{"ID":87070,"post_author":"9412100","post_date":"2022-05-05 16:00:24","post_date_gmt":"2022-05-05 20:00:24","post_content":"","post_title":"LIMSpec 2022 R2","post_excerpt":"","post_status":"publish","comment_status":"closed","ping_status":"closed","post_password":"","post_name":"limspec-2022-r1","to_ping":"","pinged":"","post_modified":"2022-12-02 12:35:37","post_modified_gmt":"2022-12-02 17:35:37","post_content_filtered":"","post_parent":0,"guid":"https:\/\/www.limsforum.com\/?post_type=ebook&p=87070","menu_order":0,"post_type":"ebook","post_mime_type":"","comment_count":"0","filter":"","_ebook_metadata":{"enabled":"on","private":"0","guid":"CA6052E9-0DBE-4786-AF7D-431F9CCD4799","title":"LIMSpec 2022 R2","subtitle":"A Regulatory-, Standards-, and Guidance-based Laboratory Informatics Specification","cover_theme":"nico_3","cover_image":"https:\/\/www.limsforum.com\/wp-content\/plugins\/rdp-ebook-builder\/pl\/cover.php?cover_style=nico_3&subtitle=A+Regulatory-%2C+Standards-%2C+and+Guidance-based+Laboratory+Informatics+Specification&editor=Shawn+Douglas&title=LIMSpec+2022+R2&title_image=https%3A%2F%2Fs3.limsforum.com%2Fwww.limsforum.com%2Fwp-content%2Fuploads%2FSystems_Requirement_Analysis.jpg&publisher=LabLynx+Press","editor":"Shawn Douglas","publisher":"LabLynx Press","author_id":"26","image_url":"https:\/\/s3.limsforum.com\/www.limsforum.com\/wp-content\/uploads\/Systems_Requirement_Analysis.jpg","items":{"5f527b047b67a208cce8ad6301dd8959_type":"article","5f527b047b67a208cce8ad6301dd8959_title":"Putting LIMSpec to use","5f527b047b67a208cce8ad6301dd8959_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Putting_LIMSpec_to_use","5f527b047b67a208cce8ad6301dd8959_plaintext":"\n\nLII:LIMSpec\/Putting LIMSpec to useFrom LIMSWikiJump to navigationJump to searchContents \n\n1 Putting those requirements to practical use \n\n1.1 Software developer considerations \n1.2 Buyer considerations \n\n1.2.1 Software vendor selection \n\n\n1.3 Caveats \n1.4 LIMSpec in Microsoft Word format \n\n\n2 References \n\n\n\nPutting those requirements to practical use \nThe LIMSpec covered laboratory informatics requirements organized into five broad categories, which are heavily influenced by the functional requirements checklist and Figure 3 of ASTM E1578-18 Standard Guide for Laboratory Informatics. However, the requirements listed prior are all based on not just the ASTM E1578 standard but also a wide variety of other standards, regulations, guidance documents, and standardized procedures (hereon out referred to as \"sources\"). That ultimately means a foundational reasoning is provided for each requirement, not necessarily a \"just because I want it\" reasoning. As foundational requirements, this LIMSpec should thus operate as an excellent starting point for building your own software requirements specification or for researching the best laboratory informatics solution for your laboratory. \nSoftware developer considerations \nWhat does that mean for you? How can you best use this document? If you're a software developer for the laboratory industry, many of the sources referenced in these requirements should already be familiar to you. However, some of them may not be, and you'll probably want to at least familiarize yourself with them. Additionally, if you're developing a generic laboratory information management system (LIMS) or some other informatics solution, not tailored to a particular industry, most everything in chapters two, three, five, and six should largely be applicable to what you're doing with your commercial off-the-shelf (COTS) software solution. Definitely review the requirements items listed there and make sure the most important ones are part of your own software requirements specification. If the software solution you're developing is tailored to a particular industry (e.g., clinical or public health, pharmaceutical development, or heavy metals testing), you'll also want to examine chapter four. If you don't see many requirements for your industry listed (see the \"Caveats\" section later), you'll probably have additional research to conduct to see what additional sources will affect how you develop the functional and, particularly, non-functional requirements. \n\nBuyer considerations \nIf you're a potential buyer of a laboratory informatics solution, this LIMSpec is also useful to you. Perhaps you know a bit about your laboratory's workflow and a few of the regulations and standards that influence how that workflow is conducted, but you're not entirely informed. Reviewing the five broad categories of requirements may be necessary to help further inform you regarding what's vital in regards to what a laboratory informatics solution should be capable of. Additionally, you can then use these requirements as a base for your laboratory's own requirements list. Using the categories and their subdivisions, you can then add those requirements that are unique to your laboratory and industry that are not sufficiently covered by the LIMSpec requirements. As you review the various options available to you and narrow down your search, your own list of requirements can be used as both as a personal checklist and as a requirements list you hand over to the vendor you query.\n\nSoftware vendor selection \nThat said, the requirements you hand off to the vendor should be discussed a bit more. Software vendor selection can at times be a tedious yet necessary process, one which requires careful planning and best practices. This topic has been written about by both software developers and end users alike, and their experiences should play a role in how you select a vendor. What follows is bullet-pointed advice as offered by some of those developers and end users.[1][2][3][4][5][6][7][8]\n\nHave a clear business case and build your business needs into your laboratory's requirements.\nBe mindful of how detailed you get with your own business-based requirements and what you initially hand off to a vendor. If you're too specific with too many requirements, you may have trouble finding a vendor that matches up. Start with the essentials that involve your laboratory's processes, regulations, integrations, reporting, service needs, etc. As this LIMSpec is foundation-based, you have a good starting point in that regard. You can always get more detailed with requirements as you narrow down vendors.\nAs discussed briefly in the introduction, you'll need to prioritize your needs somewhere between \"critical\" and \"nice to have.\" The LIMSpec's requirements are largely critical for most purposes and can be marked as such. The requirements you add will have to be prioritized more carefully.\nYou'll also want to perform some informal third-party information gathering about the vendors. Are reviews of the vendors trustworthy? Have peers had any interactions and success with the vendor? Does the vendor have the ability to scale to meet your needs?\nSchedule demonstrations of programs that seem like strong initial candidates. Make sure there is a question and answer session afterwards, and perform a post-demo evaluation.\nA formal request for proposal (RFP) may or may not be necessary, depending on the level of information you acquire prior. However, formally requesting pricing and clarification of maintenance and additional service costs is useful. Just don't let price be the only thing that guides you.\nConsider some of the intangibles. Does the vendor genuinely seem interested in your business and its needs? Do they communicate well and promptly? Do they seem flexible and able to accommodate a few special case requirements?\nBe sure to consider future needs as you anticipate potential laboratory expansion.\nDon't be afraid to choose a consultant to help you with the vendor selection process.\nCaveats \nFirst, note that this LIMSpec is still an evolving entity. Standards change. Regulations change. Procedures also change with such standards and regulations. That means that as those foundational characteristics shift, this set of requirements will have to also evolve. As such, do your homework and don't take everything you see here as fixed law. If you're responsible for investigating and\/or purchasing a laboratory informatics system, be sure you have at least some familiarity with the primary industry your laboratory serves, and by extension the regulations and standards that affect it. \nSecond, the number of industry-specific applications of laboratory informatics software continues to grow, and with it also the regulations and standards that affect those specialty laboratories. As such, some industry-specific requirements may have been missed for lack of or too expensive public-facing sources. As mentioned with the first caveat, this version of LIMSpec is evolving, and as industry experts and researchers are able to provide additional feedback on this document, it will surely grow with more relevant sources. In other words, don't consider this complete, particularly if you're in a specialized laboratory industry. You may have to add more items based on you industry knowledge and insights.\n\nLIMSpec in Microsoft Word format \nMicrosoft Excel is often used as a tool to document requirements specifications. However, one downside to Microsoft Excel is its inability to handle multiple hyperlinks in the same cell. If you've looked over the LIMSpec, you've likely noticed there are multiple hyperlinks to regulations, specifications, and guidance documents in the first column of the tables. Translating these wiki-based documents to Excel makes for a challenge when trying to maintain those hyperlinks. As they add value to not only your laboratory's requirements research but also to vendors' understanding of the sources for your requirements, it was decided the hyperlinks should be maintained in any portable version. As such, a Microsoft Word version was created.\nYou can download a copy of the Microsoft Word version of LIMSpec from LIMSwiki by going to File:LIMSpec 2022R2 v1.0.docx, right-clicking the URL under the white box, and selecting \"Save link as...\" (Alternatively, you can just click the link, open the file, and then save it.) A compromise was made between keeping the hyperlinks in the first column readable and leaving enough room in the third column for a vendor to provide a response. This response space admittedly may be a limiting factor for vendors wanting to include screenshots. If this situation arises, you may encourage the vendor to select the entire first column and delete it, then widening the response column.\nNote that this downloadable version of LIMSpec is released under the same licensing terms as this guide. Please see the first paragraph of the download for more details.\n\nReferences \n\n\n\u2191 Pearce, O. (21 June 2016). \"Software Vendor Selection: How to Define Your Requirements\". Montrium Blog. Montrium, Inc. https:\/\/blog.montrium.com\/blog\/software-vendor-selection-defining-your-requirements . Retrieved 27 April 2022 .   \n \n\n\u2191 Pearce, O. (23 June 2016). \"Software Vendor Selection: Finding the Right Vendor\". Montrium Blog. Montrium, Inc. https:\/\/blog.montrium.com\/blog\/software-vendor-selection-finding-the-right-vendor . Retrieved 27 April 2022 .   \n \n\n\u2191 Pearce, O. (28 June 2016). \"Software Vendor Selection: The Pitfalls and Successes of Vendor Demos\". Montrium Blog. Montrium, Inc. https:\/\/blog.montrium.com\/blog\/software-vendor-selection-conducting-demonstrations . Retrieved 27 April 2022 .   \n \n\n\u2191 Pearce, O. (5 July 2016). \"Software Vendor Selection: Requesting Proposals & Quotes\". Montrium Blog. Montrium, Inc. https:\/\/blog.montrium.com\/blog\/software-vendor-selection-requesting-proposals-quotes . Retrieved 27 April 2022 .   \n \n\n\u2191 Persaud, D. (4 February 2016). \"Business Requirements Gathering for Enterprise Software Selection\". SelectHub Blog. Abuyo, Inc. https:\/\/www.selecthub.com\/miscellaneous\/technology-selection\/business-requirements-gathering-enterprise-software-selection\/ . Retrieved 27 April 2022 .   \n \n\n\u2191 Lichtenberger, A. (23 July 2012). \"Six Steps for a Successful Vendor Selection\". ITIL.org. https:\/\/blog.itil.org\/2012\/07\/six-steps-for-a-successful-vendor-selection\/ . Retrieved 27 April 2022 .   \n \n\n\u2191 Poon, L. (29 May 2015). \"Insider\u2019s Guide to LIMS Selection\". Genologics Blog. GenoLogics Life Sciences Software Inc. https:\/\/www.genologics.com\/blog\/insiders-guide-to-lims-selection\/ . Retrieved 20 September 2019 .   \n[dead link ] \n\n\u2191 \"How to Select an ELN for Biology R&D\". Benchling, Inc. https:\/\/benchling.com\/static\/docs\/resources\/eln-for-biology-rnd.pdf . Retrieved 27 April 2022 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Putting_LIMSpec_to_use\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Putting_LIMSpec_to_use<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 22 January 2022, at 19:38.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2,150 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","5f527b047b67a208cce8ad6301dd8959_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Putting_LIMSpec_to_use rootpage-LII_LIMSpec_Putting_LIMSpec_to_use skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Putting LIMSpec to use<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\">\n\n<h2><span class=\"mw-headline\" id=\"Putting_those_requirements_to_practical_use\">Putting those requirements to practical use<\/span><\/h2>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Requirements_Allocation_Sheet.jpg\" class=\"image wiki-link\" data-key=\"750f6faf620baf76955d7ed0f7c86197\"><img alt=\"Requirements Allocation Sheet.jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/c\/cf\/Requirements_Allocation_Sheet.jpg\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div><p>The LIMSpec covered <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_informatics\" title=\"Laboratory informatics\" class=\"wiki-link\" data-key=\"00edfa43edcde538a695f6d429280301\">laboratory informatics<\/a> requirements organized into five broad categories, which are heavily influenced by the functional requirements checklist and Figure 3 of <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> <i>Standard Guide for Laboratory Informatics<\/i>. However, the requirements listed prior are all based on not just the ASTM E1578 standard but also a wide variety of other standards, regulations, guidance documents, and standardized procedures (hereon out referred to as \"sources\"). That ultimately means a foundational reasoning is provided for each requirement, not necessarily a \"just because I want it\" reasoning. As foundational requirements, this LIMSpec should thus operate as an excellent starting point for building your own software requirements specification or for researching the best laboratory informatics solution for your <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory\" title=\"Laboratory\" class=\"wiki-link\" data-key=\"c57fc5aac9e4abf31dccae81df664c33\">laboratory<\/a>. \n<\/p><h3><span class=\"mw-headline\" id=\"Software_developer_considerations\">Software developer considerations<\/span><\/h3>\n<p>What does that mean for you? How can you best use this document? If you're a software developer for the laboratory industry, many of the sources referenced in these requirements should already be familiar to you. However, some of them may not be, and you'll probably want to at least familiarize yourself with them. Additionally, if you're developing a generic <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_management_system\" title=\"Laboratory information management system\" class=\"wiki-link\" data-key=\"8ff56a51d34c9b1806fcebdcde634d00\">laboratory information management system<\/a> (LIMS) or some other informatics solution, not tailored to a particular industry, most everything in chapters two, three, five, and six should largely be applicable to what you're doing with your commercial off-the-shelf (COTS) software solution. Definitely review the requirements items listed there and make sure the most important ones are part of your own software requirements specification. If the software solution you're developing is tailored to a particular industry (e.g., clinical or public health, pharmaceutical development, or heavy metals testing), you'll also want to examine chapter four. If you don't see many requirements for your industry listed (see the \"Caveats\" section later), you'll probably have additional research to conduct to see what additional sources will affect how you develop the functional and, particularly, non-functional requirements. \n<\/p>\n<h3><span class=\"mw-headline\" id=\"Buyer_considerations\">Buyer considerations<\/span><\/h3>\n<p>If you're a potential buyer of a laboratory informatics solution, this LIMSpec is also useful to you. Perhaps you know a bit about your laboratory's workflow and a few of the regulations and standards that influence how that workflow is conducted, but you're not entirely informed. Reviewing the five broad categories of requirements may be necessary to help further inform you regarding what's vital in regards to what a laboratory informatics solution should be capable of. Additionally, you can then use these requirements as a base for your laboratory's own requirements list. Using the categories and their subdivisions, you can then add those requirements that are unique to your laboratory and industry that are not sufficiently covered by the LIMSpec requirements. As you review the various options available to you and narrow down your search, your own list of requirements can be used as both as a personal checklist and as a requirements list you hand over to the vendor you query.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"Software_vendor_selection\">Software vendor selection<\/span><\/h4>\n<p>That said, the requirements you hand off to the vendor should be discussed a bit more. Software vendor selection can at times be a tedious yet necessary process, one which requires careful planning and best practices. This topic has been written about by both software developers and end users alike, and their experiences should play a role in how you select a vendor. What follows is bullet-pointed advice as offered by some of those developers and end users.<sup id=\"rdp-ebb-cite_ref-PearceSoftware16_1-0\" class=\"reference\"><a href=\"#cite_note-PearceSoftware16-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PearceSoftware16-2_2-0\" class=\"reference\"><a href=\"#cite_note-PearceSoftware16-2-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PearceSoftware16-3_3-0\" class=\"reference\"><a href=\"#cite_note-PearceSoftware16-3-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PearceSoftware16-4_4-0\" class=\"reference\"><a href=\"#cite_note-PearceSoftware16-4-4\">[4]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PersaudBusiness16_5-0\" class=\"reference\"><a href=\"#cite_note-PersaudBusiness16-5\">[5]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-LichtenbergerSix12_6-0\" class=\"reference\"><a href=\"#cite_note-LichtenbergerSix12-6\">[6]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PoonInsider15_7-0\" class=\"reference\"><a href=\"#cite_note-PoonInsider15-7\">[7]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BenchlingHowTo_8-0\" class=\"reference\"><a href=\"#cite_note-BenchlingHowTo-8\">[8]<\/a><\/sup>\n<\/p>\n<ul><li>Have a clear business case and build your business needs into your laboratory's requirements.<\/li>\n<li>Be mindful of how detailed you get with your own business-based requirements and what you initially hand off to a vendor. If you're too specific with too many requirements, you may have trouble finding a vendor that matches up. Start with the essentials that involve your laboratory's processes, regulations, integrations, reporting, service needs, etc. As this LIMSpec is foundation-based, you have a good starting point in that regard. You can always get more detailed with requirements as you narrow down vendors.<\/li>\n<li>As discussed briefly in the introduction, you'll need to prioritize your needs somewhere between \"critical\" and \"nice to have.\" The LIMSpec's requirements are largely critical for most purposes and can be marked as such. The requirements you add will have to be prioritized more carefully.<\/li>\n<li>You'll also want to perform some informal third-party information gathering about the vendors. Are reviews of the vendors trustworthy? Have peers had any interactions and success with the vendor? Does the vendor have the ability to scale to meet your needs?<\/li>\n<li>Schedule demonstrations of programs that seem like strong initial candidates. Make sure there is a question and answer session afterwards, and perform a post-demo evaluation.<\/li>\n<li>A formal request for proposal (RFP) may or may not be necessary, depending on the level of information you acquire prior. However, formally requesting pricing and clarification of maintenance and additional service costs is useful. Just don't let price be the only thing that guides you.<\/li>\n<li>Consider some of the intangibles. Does the vendor genuinely seem interested in your business and its needs? Do they communicate well and promptly? Do they seem flexible and able to accommodate a few special case requirements?<\/li>\n<li>Be sure to consider future needs as you anticipate potential laboratory expansion.<\/li>\n<li>Don't be afraid to choose a consultant to help you with the vendor selection process.<\/li><\/ul>\n<h3><span class=\"mw-headline\" id=\"Caveats\">Caveats<\/span><\/h3>\n<p>First, note that this LIMSpec is still an evolving entity. Standards change. Regulations change. Procedures also change with such standards and regulations. That means that as those foundational characteristics shift, this set of requirements will have to also evolve. As such, do your homework and don't take everything you see here as fixed law. If you're responsible for investigating and\/or purchasing a laboratory informatics system, be sure you have at least some familiarity with the primary industry your laboratory serves, and by extension the regulations and standards that affect it. \n<\/p><p>Second, the number of industry-specific applications of laboratory informatics software continues to grow, and with it also the regulations and standards that affect those specialty laboratories. As such, some industry-specific requirements may have been missed for lack of or too expensive public-facing sources. As mentioned with the first caveat, this version of LIMSpec is evolving, and as industry experts and researchers are able to provide additional feedback on this document, it will surely grow with more relevant sources. In other words, don't consider this complete, particularly if you're in a specialized laboratory industry. You may have to add more items based on you industry knowledge and insights.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"LIMSpec_in_Microsoft_Word_format\">LIMSpec in Microsoft Word format<\/span><\/h3>\n<p>Microsoft Excel is often used as a tool to document requirements specifications. However, one downside to Microsoft Excel is its inability to handle multiple hyperlinks in the same cell. If you've looked over the LIMSpec, you've likely noticed there are multiple hyperlinks to regulations, specifications, and guidance documents in the first column of the tables. Translating these wiki-based documents to Excel makes for a challenge when trying to maintain those hyperlinks. As they add value to not only your laboratory's requirements research but also to vendors' understanding of the sources for your requirements, it was decided the hyperlinks should be maintained in any portable version. As such, a Microsoft Word version was created.\n<\/p><p>You can download a copy of the Microsoft Word version of LIMSpec from LIMSwiki by going to <a href=\"https:\/\/www.limswiki.org\/index.php\/File:LIMSpec_2022R2_v1.0.docx\" title=\"File:LIMSpec 2022R2 v1.0.docx\" class=\"wiki-link\" data-key=\"6ecc50a09cbc136f1ea678e477ab2dac\">File:LIMSpec 2022R2 v1.0.docx<\/a>, right-clicking the URL under the white box, and selecting \"Save link as...\" (Alternatively, you can just click the link, open the file, and then save it.) A compromise was made between keeping the hyperlinks in the first column readable and leaving enough room in the third column for a vendor to provide a response. This response space admittedly may be a limiting factor for vendors wanting to include screenshots. If this situation arises, you may encourage the vendor to select the entire first column and delete it, then widening the response column.\n<\/p><p>Note that this downloadable version of LIMSpec is released under the same licensing terms as this guide. Please see the first paragraph of the download for more details.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap\"><ol class=\"references\">\n<li id=\"cite_note-PearceSoftware16-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PearceSoftware16_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Pearce, O. (21 June 2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-defining-your-requirements\" target=\"_blank\">\"Software Vendor Selection: How to Define Your Requirements\"<\/a>. <i>Montrium Blog<\/i>. Montrium, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-defining-your-requirements\" target=\"_blank\">https:\/\/blog.montrium.com\/blog\/software-vendor-selection-defining-your-requirements<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 27 April 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Software+Vendor+Selection%3A+How+to+Define+Your+Requirements&rft.atitle=Montrium+Blog&rft.aulast=Pearce%2C+O.&rft.au=Pearce%2C+O.&rft.date=21+June+2016&rft.pub=Montrium%2C+Inc&rft_id=https%3A%2F%2Fblog.montrium.com%2Fblog%2Fsoftware-vendor-selection-defining-your-requirements&rfr_id=info:sid\/en.wikipedia.org:LII:LIMSpec\/Putting_LIMSpec_to_use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PearceSoftware16-2-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PearceSoftware16-2_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Pearce, O. (23 June 2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-finding-the-right-vendor\" target=\"_blank\">\"Software Vendor Selection: Finding the Right Vendor\"<\/a>. <i>Montrium Blog<\/i>. Montrium, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-finding-the-right-vendor\" target=\"_blank\">https:\/\/blog.montrium.com\/blog\/software-vendor-selection-finding-the-right-vendor<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 27 April 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Software+Vendor+Selection%3A+Finding+the+Right+Vendor&rft.atitle=Montrium+Blog&rft.aulast=Pearce%2C+O.&rft.au=Pearce%2C+O.&rft.date=23+June+2016&rft.pub=Montrium%2C+Inc&rft_id=https%3A%2F%2Fblog.montrium.com%2Fblog%2Fsoftware-vendor-selection-finding-the-right-vendor&rfr_id=info:sid\/en.wikipedia.org:LII:LIMSpec\/Putting_LIMSpec_to_use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PearceSoftware16-3-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PearceSoftware16-3_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Pearce, O. (28 June 2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-conducting-demonstrations\" target=\"_blank\">\"Software Vendor Selection: The Pitfalls and Successes of Vendor Demos\"<\/a>. <i>Montrium Blog<\/i>. Montrium, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-conducting-demonstrations\" target=\"_blank\">https:\/\/blog.montrium.com\/blog\/software-vendor-selection-conducting-demonstrations<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 27 April 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Software+Vendor+Selection%3A+The+Pitfalls+and+Successes+of+Vendor+Demos&rft.atitle=Montrium+Blog&rft.aulast=Pearce%2C+O.&rft.au=Pearce%2C+O.&rft.date=28+June+2016&rft.pub=Montrium%2C+Inc&rft_id=https%3A%2F%2Fblog.montrium.com%2Fblog%2Fsoftware-vendor-selection-conducting-demonstrations&rfr_id=info:sid\/en.wikipedia.org:LII:LIMSpec\/Putting_LIMSpec_to_use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PearceSoftware16-4-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PearceSoftware16-4_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Pearce, O. (5 July 2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-requesting-proposals-quotes\" target=\"_blank\">\"Software Vendor Selection: Requesting Proposals & Quotes\"<\/a>. <i>Montrium Blog<\/i>. Montrium, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-requesting-proposals-quotes\" target=\"_blank\">https:\/\/blog.montrium.com\/blog\/software-vendor-selection-requesting-proposals-quotes<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 27 April 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Software+Vendor+Selection%3A+Requesting+Proposals+%26+Quotes&rft.atitle=Montrium+Blog&rft.aulast=Pearce%2C+O.&rft.au=Pearce%2C+O.&rft.date=5+July+2016&rft.pub=Montrium%2C+Inc&rft_id=https%3A%2F%2Fblog.montrium.com%2Fblog%2Fsoftware-vendor-selection-requesting-proposals-quotes&rfr_id=info:sid\/en.wikipedia.org:LII:LIMSpec\/Putting_LIMSpec_to_use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PersaudBusiness16-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PersaudBusiness16_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Persaud, D. (4 February 2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.selecthub.com\/miscellaneous\/technology-selection\/business-requirements-gathering-enterprise-software-selection\/\" target=\"_blank\">\"Business Requirements Gathering for Enterprise Software Selection\"<\/a>. <i>SelectHub Blog<\/i>. Abuyo, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.selecthub.com\/miscellaneous\/technology-selection\/business-requirements-gathering-enterprise-software-selection\/\" target=\"_blank\">https:\/\/www.selecthub.com\/miscellaneous\/technology-selection\/business-requirements-gathering-enterprise-software-selection\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 27 April 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Business+Requirements+Gathering+for+Enterprise+Software+Selection&rft.atitle=SelectHub+Blog&rft.aulast=Persaud%2C+D.&rft.au=Persaud%2C+D.&rft.date=4+February+2016&rft.pub=Abuyo%2C+Inc&rft_id=https%3A%2F%2Fwww.selecthub.com%2Fmiscellaneous%2Ftechnology-selection%2Fbusiness-requirements-gathering-enterprise-software-selection%2F&rfr_id=info:sid\/en.wikipedia.org:LII:LIMSpec\/Putting_LIMSpec_to_use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-LichtenbergerSix12-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-LichtenbergerSix12_6-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Lichtenberger, A. (23 July 2012). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/blog.itil.org\/2012\/07\/six-steps-for-a-successful-vendor-selection\/\" target=\"_blank\">\"Six Steps for a Successful Vendor Selection\"<\/a>. <i>ITIL.org<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/blog.itil.org\/2012\/07\/six-steps-for-a-successful-vendor-selection\/\" target=\"_blank\">https:\/\/blog.itil.org\/2012\/07\/six-steps-for-a-successful-vendor-selection\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 27 April 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Six+Steps+for+a+Successful+Vendor+Selection&rft.atitle=ITIL.org&rft.aulast=Lichtenberger%2C+A.&rft.au=Lichtenberger%2C+A.&rft.date=23+July+2012&rft_id=https%3A%2F%2Fblog.itil.org%2F2012%2F07%2Fsix-steps-for-a-successful-vendor-selection%2F&rfr_id=info:sid\/en.wikipedia.org:LII:LIMSpec\/Putting_LIMSpec_to_use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PoonInsider15-7\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PoonInsider15_7-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Poon, L. (29 May 2015). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.genologics.com\/blog\/insiders-guide-to-lims-selection\/\" target=\"_blank\">\"Insider\u2019s Guide to LIMS Selection\"<\/a>. <i>Genologics Blog<\/i>. GenoLogics Life Sciences Software Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.genologics.com\/blog\/insiders-guide-to-lims-selection\/\" target=\"_blank\">https:\/\/www.genologics.com\/blog\/insiders-guide-to-lims-selection\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 20 September 2019<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Insider%E2%80%99s+Guide+to+LIMS+Selection&rft.atitle=Genologics+Blog&rft.aulast=Poon%2C+L.&rft.au=Poon%2C+L.&rft.date=29+May+2015&rft.pub=GenoLogics+Life+Sciences+Software+Inc&rft_id=https%3A%2F%2Fwww.genologics.com%2Fblog%2Finsiders-guide-to-lims-selection%2F&rfr_id=info:sid\/en.wikipedia.org:LII:LIMSpec\/Putting_LIMSpec_to_use\"><span style=\"display: none;\"> <\/span><\/span>\n<sup class=\"noprint Inline-Template\"><span style=\"white-space: nowrap;\">[<i><a href=\"https:\/\/en.wikipedia.org\/wiki\/Wikipedia:Link_rot\" class=\"extiw wiki-link\" title=\"wikipedia:Wikipedia:Link rot\" data-key=\"8e73a2ff6f82d88817bdd8ee8b302ab7\"><span title=\" Dead link since April 2022\">dead link<\/span><\/a><\/i>]<\/span><\/sup><\/span>\n<\/li>\n<li id=\"cite_note-BenchlingHowTo-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BenchlingHowTo_8-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/benchling.com\/static\/docs\/resources\/eln-for-biology-rnd.pdf\" target=\"_blank\">\"How to Select an ELN for Biology R&D\"<\/a>. Benchling, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/benchling.com\/static\/docs\/resources\/eln-for-biology-rnd.pdf\" target=\"_blank\">https:\/\/benchling.com\/static\/docs\/resources\/eln-for-biology-rnd.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 27 April 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=How+to+Select+an+ELN+for+Biology+R%26D&rft.atitle=&rft.pub=Benchling%2C+Inc&rft_id=https%3A%2F%2Fbenchling.com%2Fstatic%2Fdocs%2Fresources%2Feln-for-biology-rnd.pdf&rfr_id=info:sid\/en.wikipedia.org:LII:LIMSpec\/Putting_LIMSpec_to_use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20221202173244\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.135 seconds\nReal time usage: 0.194 seconds\nPreprocessor visited node count: 5820\/1000000\nPost\u2010expand include size: 47376\/2097152 bytes\nTemplate argument size: 15659\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 12307\/5000000 bytes\nLua time usage: 0.030\/7 seconds\nLua virtual size: 5488640\/52428800 bytes\nLua estimated memory usage: 0 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 173.148 1 -total\n 94.66% 163.910 1 Template:Reflist\n 48.66% 84.255 1 Template:Dead_link\n 46.51% 80.533 1 Template:Fix\n 40.26% 69.701 1 Template:Category_handler\n 38.38% 66.457 8 Template:Cite_web\n 34.70% 60.087 8 Template:Citation\/core\n 8.95% 15.502 7 Template:Date\n 5.28% 9.139 1 Template:LIMSpec\/Putting_LIMSpec_to_use\n 4.11% 7.119 15 Template:Citation\/make_link\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11216-0!canonical and timestamp 20221202173244 and revision id 45967. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Putting_LIMSpec_to_use\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Putting_LIMSpec_to_use<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","5f527b047b67a208cce8ad6301dd8959_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/c\/cf\/Requirements_Allocation_Sheet.jpg"],"5f527b047b67a208cce8ad6301dd8959_timestamp":1670002548,"111b080aebf48e07f19c5b0f8f2b6a2e_type":"article","111b080aebf48e07f19c5b0f8f2b6a2e_title":"36. Information privacy","111b080aebf48e07f19c5b0f8f2b6a2e_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#36._Information_privacy","111b080aebf48e07f19c5b0f8f2b6a2e_plaintext":"\n\nLII:LIMSpec\/Security and Integrity of Systems and OperationsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.\n\n31. Data integrity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-17-1\r\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\nWHO Technical Report Series, #996, Annex 5, 9.1\n\n31.1 System functionality should support ALCOA principles.\n\n\n\n61 FR 38806, 9 CFR Part 417.5\r\n\nASTM E1578-18 E-17-2\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nA2LA C211 4.13.2.3\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nNIST 800-53, Rev. 5, SI-12\n\n\n31.2 The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.\n\n\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 58.190\r\n\n42 CFR Part 93.305\r\n\n42 CFR Part 93.310\r\n\nASTM E1578-18 E-17-3\r\n\nCLSI QMS22 2.2.2.2\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\r\n\nNIST 800-53, Rev. 5, SI-12\r\n\nOECD GLP Principles 10\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\r\n\nUSDA Data and Instrumentation for PDP 8.1.3\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n\n31.3 The system shall securely maintain a true, readable copy of an instrument's original (raw) data for on-demand review.\n\n\n\n7 CFR Part 91.30\r\n\n7 CFR Part 331.17 (c)\r\n\n9 CFR Part 2.35\r\n\n9 CFR Part 121.17 (c)\r\n\n10 CFR Part 20.2103\u201310\r\n\n10 CFR Part 30.34 (g)\r\n\n10 CFR Part 30.51\u20132\r\n\n21 CFR Part 1.1154 (a)\r\n\n21 CFR Part 11.10 (c)\r\n\n21 CFR Part 58.195\r\n\n21 CFR Part 106.100 (n)\r\n\n21 CFR Part 112.164\r\n\n21 CFR Part 114.100 (e)\r\n\n21 CFR Part 117.315\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.9\r\n\n21 CFR Part 129.80 (h)\r\n\n21 CFR Part 211.180\r\n\n21 CFR Part 212.110 (c)\r\n\n21 CFR Part 225.42 (b-8)\r\n\n21 CFR Part 225.58 (c\u2013d)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 225.110\r\n\n21 CFR Part 225.158\r\n\n21 CFR Part 225.202\r\n\n21 CFR Part 226.42 (a)\r\n\n21 CFR Part 226.58 (f)\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 226.115\r\n\n21 CFR Part 312.57\r\n\n21 CFR Part 312.62\r\n\n21 CFR Part 507.208\r\n\n21 CFR Part 606.160 (d)\r\n\n21 CFR Part 812.140 (d)\r\n\n21 CFR Part 820.180 (b)\r\n\n29 CFR Part 1910.120 (f)(8)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n40 CFR Part 141.33\r\n\n40 CFR Part 141.722\r\n\n40 CFR Part 262.11 (f)\r\n\n40 CFR Part 262.40\r\n\n40 CFR Part 262.213\r\n\n40 CFR Part 704 Subpart A\r\n\n40 CFR Part 717.15 (d)\r\n\n42 CFR Part 73.17 (c)\r\n\n42 CFR Part 93.313 (h)\r\n\n42 CFR Part 93.317\r\n\n42 CFR Part 493.1105\r\n\n42 CFR Part 493.1283\r\n\n45 CFR Part 164.105\r\n\n45 CFR Part 164.316\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\n61 FR 38806, 9 CFR Part 417.5\r\n\nA2LA C223 5.4\r\n\nA2LA C223 5.9\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.1.2\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.2.1\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.3.2\r\n\nABFT Accreditation Manual Sec. E-33\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.6\r\n\nACMG Technical Standards for Clinical Genetics Laboratories E2.1\r\n\nAIHA-LAP Policies 2022 2A.7.5.1\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7\r\n\nASTM E1578-18 E-17-4\r\n\nBRC GSFS, Issue 8, 3.3.2\r\n\nCAP Laboratory Accreditation Manual\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.3.4\r\n\nCJIS Security Policy 5.4.6\u20137\r\n\nCJIS Security Policy 5.5.2.1\r\n\nCLSI QMS22 2.8.3\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.4\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nE.U. Annex 11-7.1\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.1\r\n\nE.U. Commission Directive 2003\/94\/EC Article 11.4\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c\r\n\nEPA 815-R-05-004 Chap. III, Sec. 15\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nEPA ERLN Laboratory Requirements 4.9.18\r\n\nEPA ERLN Laboratory Requirements 4.11.17\r\n\nEPA QA\/G-5 2.1.9\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3\r\n\nICH GCP 4.9.5\r\n\nIFS Food 7, Part 2, 2.1.2.2\r\n\nIFS PACsecure 2, Part 2, 2.1.2.2\r\n\nISO 15189:2012 4.3\r\n\nISO\/IEC 17025:2017 8.4.2\r\n\nNIST 800-53, Rev. 5, AT-4\r\n\nNIST 800-53, Rev. 5, AU-11 and AU-11(1)\r\n\nNIST 800-53, Rev. 5, SI-12\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 10\r\n\nOSHA 1910.1020(d)(1)(i\u2013ii)\r\n\nOSHA 1910.1450(j)(2)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.2.3.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP 5.4\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c\r\n\nUSDA Sampling Procedures for PDP 6.5\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0\r\n\nWHO Technical Report Series, #986, Annex 2, 15.8\u20139\r\n\nWHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1\n\n\n31.4 The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.\n\n\nASTM E1578-18 E-17-6\r\nCJIS Security Policy 5.4.4\r\nNIST 800-53, Rev. 5, AU-8\r\nWHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n31.5 The system shall accurately reflect the system date and time in its use of electronic record time stamps.\n\n\nAPHL 2019 LIS Project Management Guidebook\r\nASTM E1578-18 E-17-7\r\nCJIS Security Policy 5.6.1\n\n31.6 The system shall require each and every user to be assigned a unique user ID.\n\n\n\nASTM E1578-18 E-17-8\r\n\n21 CFR Part 11.10 (e)\r\n\nCJIS Security Policy 5.4.5\r\n\nE.U. Annex 11-9\r\n\nNIST 800-53, Rev. 5, AU-9\n\n\n31.7 The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.\n\n\nCJIS Security Policy 5.4.2\r\nNIST 800-53, Rev. 5, AU-5\r\nNIST 800-53, Rev. 5, SI-4\n\n31.8 The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.\n\n\n\n32. Configuration management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 S-1-1\r\nAPHL 2019 LIS Project Management Guidebook\n\n32.1 The system shall provide tools to enter and manage user-configurable lookup or master data.\n\n\nASTM E1578-18 S-1-2\n\n32.2 The system shall allow authorized users to configure the specification limits for sample and instrument tests.\n\n\n45 CFR Part 162.1002\r\nUSDA Sampling Procedures for PDP 6.3.2\n\n32.3 The system shall allow system nomenclature to be configured to use specific data code sets\u2014such as the International Classification of Diseases or the Healthcare Common Procedure Coding System\u2014or mandated terminology to support regulatory requirements.\n\n\nASTM E1578-18 S-1-3\n\n32.4 The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.\n\n\nASTM E1578-18 S-1-4\n\n32.5 The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.\n\n\n21 CFR Part 211.100 (b)\r\n21 CFR Part 211.160 (a)\n\n32.6 The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.\n\n\n\n40 CFR Part 3.10\r\n\n40 CFR Part 3.2000\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C13.3\r\n\nASTM E1578-18 S-1-5\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.7 The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.\n\n\nASTM E1578-18 S-1-6\n\n32.8 The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.\n\n\nASTM E1578-18 S-1-7\n\n32.9 The system shall support configurable laboratory workflows based on appropriate laboratory process and procedure.\n\n\nASTM E1578-18 S-1-8\n\n32.10 The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of laboratory workflow.\n\n\n21 CFR Part 211.68\r\nAPHL 2019 LIS Project Management Guidebook\r\nASTM E1578-18 S-1-9\n\n32.11 The system should allow authorized personnel to perform revision control of lookup or master data.\n\n\nASTM E1578-18 S-1-10\r\nAPHL 2019 LIS Project Management Guidebook\n\n32.12 The system should provide a means for importing lookup or master data.\n\n\n\nAIHA-LAP Policies 2022 2A.7.8.4\r\n\nASTM E1578-18 S-1-11\r\n\nEPA ERLN Laboratory Requirements 4.11.6\r\n\nUSDA Data and Instrumentation for PDP 9.1\n\n\n32.13 The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.\n\n\nASTM E1578-18 S-1-12\n\n32.14 The system should allow calculated limits to be created and managed based on test results and relevant metadata.\n\n\nASTM E1578-18 S-1-13\r\nEPA ERLN Laboratory Requirements 3.2.6\r\nEPA ERLN Laboratory Requirements 4.9.11\n\n32.15 The system should provide a clear alert or notification upon entry of out-of-specification results.\n\n\nASTM E1578-18 S-1-14\n\n32.16 The system shall allow authorized personnel to update static and dynamic data.\n\n\nASTM E1578-18 S-1-15\n\n32.17 The system should allow workflow events and status changes to trigger one or more user-defined actions.\n\n\nASTM E1578-18 S-1-17\r\n\nCJIS Security Policy 5.7.1\r\n\nNIST 800-53, Rev. 5, AC-6(1)\r\n\nNIST 800-53, Rev. 5, CM-7\n\n\n32.18 The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.\n\n\nASTM E1578-18 S-1-18\r\nCAP Laboratory Accreditation Manual\n\n32.19 The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.\n\n\nASTM E1578-18 S-1-19\n\n32.20 The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.\n\n\n21 CFR Part 11.100 (a)\r\n\nASTM E1578-18 S-1-20\r\n\nE.U. Annex 11-14\r\n\nNIST 800-53, Rev. 5, CM-5(1)\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.21 The system should support rules governing electronic records and electronic signatures in regulated environments.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n10 CFR Part 20.2110\r\n\n10 CFR Part 30.51 (c-1\r\n\n21 CFR Part 11.10 (d)\r\n\n21 CFR Part 211.68\r\n\n42 CFR Part 73.11\r\n\n45 CFR Part 164.308\r\n\nA2LA C211 4.13.1.4\r\n\nA2LA C211 5.4.7.2\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.4.1\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\nASTM E1492-11 4.2.4\r\n\nASTM E1578-18 S-1-16\r\n\nASTM E1578-18 S-1-21\r\n\nCJIS Security Policy 5.5.2\r\n\nCLSI QMS22 2.4.3\r\n\nE.U. Annex 11-12\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nEPA ERLN Laboratory Requirements 4.9.4 and 4.9.14\r\n\nICH GCP 2.10\r\n\nISO\/IEC 17025:2017 7.11.3\r\n\nNIST 800-53, Rev. 5, CM-5 and CM-5(1)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\n\n\n32.22 The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.\n\n\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nCJIS Security Policy 5.5.2.2\u20133\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nNIST 800-53, Rev. 5, AC-2(11)\n\n\n32.23 The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.\n\n\nASTM E1578-18 S-1-22\r\nNIST 800-53, Rev. 5, IA-2(10)\n\n32.24 The system should support single sign-on such that a user can log in once and access all permitted functions and data.\n\n\n\n21 CFR Part 11.200 (a)\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d)\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCJIS Security Policy 5.6.1\r\n\nCLSI QMS22 2.4.2.2\r\n\nE.U. Annex 11-14\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nEPA ERLN Laboratory Requirements 4.9.4\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\nNIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\r\n\nNIST 800-53, Rev. 5, MA-4\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.25 The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.\n\n\n\n21 CFR Part 11.300 (a)\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, IA-4 and IA-5\n\n\n32.26 The system shall prevent the same combination of identification components from being used across more than one account.\n\n\n\n21 CFR Part 11.300 (b)\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCLSI QMS22 2.4.2\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, IA-5 and IA-5(1)\n\n\n32.27 The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.\n\n\nCJIS Security Policy 5.6.3.1\r\nNIST 800-53, Rev. 5, AC-2(3)\r\n\nNIST 800-53, Rev. 5, IA-4 and IA-5(1)\r\n\nNIST 800-53, Rev. 5, PS-4\n\n\n32.28 The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.\n\n\nCJIS Security Policy 5.5.2.2\r\nNIST 800-53, Rev. 5, AC-10\n\n32.29 The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.\n\n\nCJIS Security Policy 5.5.4\r\nNIST 800-53, Rev. 5, AC-8\n\n32.30 The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.\n\n\n\n21 CFR Part 11.300 (d)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\nA2LA C211 4.13.2.1\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCLSI QMS22 2.4.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, CM-5(1)\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\n\n\n32.31 The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.\n\n\n\n21 CFR Part 11.300 (d)\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCJIS Security Policy 5.5.3\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, AC-7\n\n\n32.32 The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.\n\n\n21 CFR Part 11.200 (a)\r\nASTM E1578-18 S-3-1\n\n32.33 The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.200 (a)\r\n\n21 CFR Part 211.68 (b)\r\n\n21 CFR Part 211.188 (b-11)\r\n\n21 CFR Part 211.194 (a-7 and a-8)\r\n\n21 CFR Part 212.50 (c-10)\r\n\n42 CFR Part 73.11\r\n\nASTM E1578-18 S-3-1\r\n\nCJIS Security Policy 5.6.3.2\r\n\nNIST 800-53, Rev. 5, IA-5\n\n\n32.34 The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.10 (d)\r\n\n42 CFR Part 73.11\r\n\n42 CFR Part 493.1231\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.514\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 S-1-25\r\n\nCJIS Security Policy 5.5.1\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nNIST 800-53, Rev. 5, AC-3\r\n\nNIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\n\n\n32.35 The system shall support the ability to initially assign new individual users to system groups, roles, or both.\n\n\n\n21 CFR Part 11.100 (a)\r\n\n45 CFR Part 164.312\r\n\nASTM E1578-18 S-1-24\r\n\nE.U. Annex 11-14\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.36 The system shall force a user's electronic signature to be unique and traceable to a specific user's account.\n\n\n21 CFR Part 11.100 (a)\r\nASTM E1578-18 S-1-24\r\n\n\n32.37 The system shall prevent the reuse or reassignment of a user's electronic signature.\n\n\n21 CFR Part 11.50\r\nE.U. Annex 11-14\n\n32.38 When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.\n\n\n\nASTM E1578-18 S-1-26\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nCLSI QMS22 2.8.5.3\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.39 The system should provide a means to migrate static data into the system.\n\n\nNIST 800-53, Rev. 5, IA-5(1)\r\nCLSI QMS22 2.4.2\n\n32.40 The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.\n\n\nNIST 800-53, Rev. 5, IA-6\n\n32.41 The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.\n\n\n\n33. System validation and commission \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 S-2-1\r\nCJIS Security Policy Appendix G.8\r\nNIST 800-53, Rev. 5, SA-4(3)\n\n33.1 The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.\n\n\nASTM E1578-18 S-2-2\r\nNIST 800-53, Rev. 5, SA-4(2)\n\n33.2 The vendor should be willing to provide access to source code through a suitable escrow.\n\n\nASTM E1578-18 S-2-3\n\n33.3 The system should be able to document a summary and evaluation of enterprise performance markers and processes.\n\n\n\nA2LA C211 5.4.7.2\r\n\nASTM E1578-18 S-2-4\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 7.11.5\r\n\nNIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5\n\n\n33.4 The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.\n\n\n\n21 CFR Part 11.10 (a)\r\n\n21 CFR Part 820.70 (i)\r\n\nA2LA C211 5.4.7.2\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nE.U. Annex 11-11\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 7.11.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 4.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)\r\n\nWHO Technical Report Series, #996, Annex 5, 10.2\n\n\n33.5 The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.\n\n\nASTM E1578-18 S-2-2\r\nCLSI QMS22 2.5\r\nE.U. Annex 11-4\r\nWHO Technical Report Series, #996, Annex 5, 10.3\u20137\n\n33.6 The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.\n\n\n\n34. System administration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 11.200 (a)\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d-5)\r\n\nASTM E1578-18 S-3-1\r\n\nCJIS Security Policy 5.5.5\r\n\nCLSI QMS22 2.4.2\r\n\nNIST 800-53, Rev. 5, AC-11 and AC-12\n\n\n34.1 The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.\n\n\nASTM E1578-18 S-3-2\n\n34.2 The system should provide a means for modifying personnel data in a batch.\n\n\nASTM E1578-18 S-3-3\n\n34.3 The system should support the storage of standard and industry-specific data formats.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.10 (d)\r\n\n21 CFR Part 211.68 (b)\r\n\n42 CFR Part 73.11\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.514\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 S-3-7\r\n\nCJIS Security Policy 5.5.1\r\n\nCJIS Security Policy 5.5.2.4\r\n\nCJIS Security Policy Appendix G.5\r\n\nCLSI QMS22 2.4.2\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nISO 15189:2012 5.10.2\r\n\nNIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\nNIST 800-53, Rev. 5, IA-2 and IA-8\r\n\nNIST 800-53, Rev. 5, MA-4\r\n\nNIST 800-53, Rev. 5, PS-4 and PS-5\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Administrative Procedures for the PDP 5.5.1.2\r\n\nWHO Technical Report Series, #996, Annex 5, 5.4 and Appendix 1\n\n\n34.4 The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.\n\n\nASTM E1578-18 S-3-8\n\n34.5 The vendor should provide maintenance agreements and support services for its applications and services.\n\n\nASTM E1578-18 S-3-9\r\n\nE.U. Annex 11-3.3\r\n\nNIST 800-53, Rev. 5, SA-16\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\n\n\n34.6 The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.10 (c)\r\n\n42 CFR Part 73.11\r\n\n45 CFR Part 164.310\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.4.3\r\n\nABFT Accreditation Manual Sec. D-5\u2013D-8\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\nASTM E1492-11 4.2.4\r\n\nCJIS Security Policy 5.5.2\r\n\nCJIS Security Policy 5.8.1\r\n\nEPA ERLN Laboratory Requirements 4.9.6\r\n\nE.U. Annex 11-7.1\r\n\nE.U. Annex 11-12\r\n\nISO 15189:2012 5.10.2\r\n\nISO\/IEC 17025:2017 7.11.3\r\n\nNIST 800-53, Rev. 5, MA-5\r\n\nNIST 800-53, Rev. 5, MP-2\r\n\nNIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\n\n\n34.7 The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)\n\n\nCJIS Security Policy 5.5.1\n\n34.8 The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n42 CFR Part 73.17\r\n\nASTM E1578-18 S-3-10\n\n\n34.9 The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n42 CFR Part 73.11\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 S-3-11\r\n\nCJIS Security Policy 5.10.4.1\r\n\nCLSI QMS22 2.1.4\r\n\nCLSI QMS22 2.6.1\r\n\nEPA ERLN Laboratory Requirements 4.9.13\r\n\nNIST 800-53, Rev. 5, SI-2(5)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n34.10 The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.\n\n\nASTM E1578-18 S-3-12\n\n34.11 The system shall provide a means for migrating data to a new release upon system upgrade.\n\n\n21 CFR Part 1.1154 (b)\r\nASTM E1578-18 S-3-13\n\n34.12 The system should be expedient with the retrieval of stored items.\n\n\n\n21 CFR Part 11.10 (b)\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nE.U. Annex 11-5\r\n\nE.U. Annex 11-8.1\n\n\n34.13 The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.\n\n\nASTM E1578-18 S-3-14\n\n34.14 The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.\n\n\nASTM E1578-18 S-3-15\r\n\nEPA ERLN Laboratory Requirements 4.9.13\r\n\nNIST 800-53, Rev. 5, CM-3(2)\r\n\nNIST 800-53, Rev. 5, SI-2\n\n\n34.15 The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.\n\n\n\n35. Cybersecurity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n42 CFR Part 493.1231\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d-9)\r\n\nASTM E1578-18 S-4-1\r\n\nCJIS Security Policy 5.6.4\r\n\nCJIS Security Policy 5.8.2.1\r\n\nCJIS Security Policy 5.10.1.2\r\n\nCJIS Security Policy Appendix G.6\r\n\nCLSI QMS22 2.2.3.2\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nNIST 800-53, Rev. 5, AC-17(2)\n\n\n35.1 The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.\n\n\n\n42 CFR Part 493.1231\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d)\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.6\r\n\nASTM E1578-18 S-4-2\r\n\nCJIS Security Policy 5.5.2.4\r\n\nCJIS Security Policy 5.10.1.2\r\n\nCJIS Security Policy Appendix G.6\r\n\nNIST 800-53, Rev. 5, SC-13 and SC-28(1)\n\n\n35.2 The system should support database encryption and be capable of recording the encryption status of the data contained within.\n\n\n42 CFR Part 493.1231\r\n\nCJIS Security Policy 5.6.2.2.1\r\n\nCLSI QMS22 2.4.2.2\r\n\nNIST 800-53, Rev. 5, AC-3\r\n\nNIST 800-53, Rev. 5, IA-2, IA-2(1\u20134), and IA-8\r\n\nNIST 800-53, Rev. 5, MA-4\n\n\n35.3 The system should be able to support multifactor authentication.\n\n\n45 CFR Part 170.202\r\n45 CFR Part 170.315 (h)\n\n35.4 The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information.\n\n\nNIST 800-53, Rev. 5, IA-7\n\n35.5 The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.\n\n\nNIST 800-53, Rev. 5, SC-15\n\n35.6 The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.\n\n\n\n36. Information privacy \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n45 CFR Part 164 Subpart E\r\nACMG Technical Standards for Clinical Genetics Laboratories G17.2\r\nASTM E1578-18 S-5-1\r\nCAP Laboratory Accreditation Manual\n\n36.1 The system shall comply with privacy protection compliance like that found in HIPAA provisions.\n\n\n\n10 CFR Part 20.2106 (d)\r\n\n45 CFR Part 164.105\r\n\n45 CFR Part 164 Subpart C\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 S-5-2\r\n\nICH GCP 2.11\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.3\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\n\n\n36.2 The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.\n\n\n45 CFR Part 164.514\r\nACMG Technical Standards for Clinical Genetics Laboratories C5.5\r\nCAP Laboratory Accreditation Manual\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3\n\n\n36.3 The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.\n\n\n45 CFR Part 164 Subpart E\r\n\nNIST 800-53, Rev. 5, AC-6\n\n\n36.4 The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.\n\n\nNIST 800-53, Rev. 5, SI-19(7)\n\n36.5 The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#36._Information_privacy\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#36._Information_privacy<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 20 September 2019, at 18:12.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 1,950 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","111b080aebf48e07f19c5b0f8f2b6a2e_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Security_and_Integrity_of_Systems_and_Operations rootpage-LII_LIMSpec_Security_and_Integrity_of_Systems_and_Operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Security and Integrity of Systems and Operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"31._Data_integrity\">31. Data integrity<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 9.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.1<\/b> System functionality should support ALCOA principles.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.2<\/b> The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.305\" target=\"_blank\">42 CFR Part 93.305<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.310\" target=\"_blank\">42 CFR Part 93.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.3<\/b> The system shall securely maintain a true, readable copy of an instrument's original (raw) data for on-demand review.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.30\" target=\"_blank\">7 CFR Part 91.30<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.195\" target=\"_blank\">21 CFR Part 58.195<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (n)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.164<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.180\" target=\"_blank\">21 CFR Part 211.180<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 212.110 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42 (b-8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (c\u2013d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.202\" target=\"_blank\">21 CFR Part 225.202<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.115\" target=\"_blank\">21 CFR Part 226.115<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.208<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.160\" target=\"_blank\">21 CFR Part 606.160 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.180\" target=\"_blank\">21 CFR Part 820.180 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120 (f)(8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.722\" target=\"_blank\">40 CFR Part 141.722<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.11\" target=\"_blank\">40 CFR Part 262.11 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.40\" target=\"_blank\">40 CFR Part 262.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.213\" target=\"_blank\">40 CFR Part 262.213<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\/subpart-A\" target=\"_blank\">40 CFR Part 704 Subpart A<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/717.15\" target=\"_blank\">40 CFR Part 717.15 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.313\" target=\"_blank\">42 CFR Part 93.313 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.317\" target=\"_blank\">42 CFR Part 93.317<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1105\" target=\"_blank\">42 CFR Part 493.1105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.105\" target=\"_blank\">45 CFR Part 164.105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.316\" target=\"_blank\">45 CFR Part 164.316<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories E2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.4<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.18<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 2.1.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 2.1.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-11 and AU-11(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020(d)(1)(i\u2013ii)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(j)(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.8\u20139<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.4<\/b> The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.5<\/b> The system shall accurately reflect the system date and time in its use of electronic record time stamps.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-7<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.6<\/b> The system shall require each and every user to be assigned a unique user ID.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.7<\/b> The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.8<\/b> The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"32._Configuration_management\">32. Configuration management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.1<\/b> The system shall provide tools to enter and manage user-configurable lookup or master data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.2<\/b> The system shall allow authorized users to configure the specification limits for sample and instrument tests.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/162.1002\" target=\"_blank\">45 CFR Part 162.1002<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.3.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.3<\/b> The system shall allow system nomenclature to be configured to use specific data code sets\u2014such as the International Classification of Diseases or the Healthcare Common Procedure Coding System\u2014or mandated terminology to support regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.4<\/b> The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.5<\/b> The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.6<\/b> The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.10\" target=\"_blank\">40 CFR Part 3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.2000\" target=\"_blank\">40 CFR Part 3.2000<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C13.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.7<\/b> The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.8<\/b> The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.9<\/b> The system shall support configurable laboratory workflows based on appropriate laboratory process and procedure.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.10<\/b> The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of laboratory workflow.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.11<\/b> The system should allow authorized personnel to perform revision control of lookup or master data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-10<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.12<\/b> The system should provide a means for importing lookup or master data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 9.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.13<\/b> The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.14<\/b> The system should allow calculated limits to be created and managed based on test results and relevant metadata.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-13<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.15<\/b> The system should provide a clear alert or notification upon entry of out-of-specification results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.16<\/b> The system shall allow authorized personnel to update static and dynamic data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-15<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.17<\/b> The system should allow workflow events and status changes to trigger one or more user-defined actions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-17<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.18<\/b> The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-18<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.19<\/b> The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-19<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.20<\/b> The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.21<\/b> The system should support rules governing electronic records and electronic signatures in regulated environments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2110\" target=\"_blank\">10 CFR Part 20.2110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51 (c-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4 and 4.9.14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5 and CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.22<\/b> The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(11)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.23<\/b> The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-22<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2(10)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.24<\/b> The system should support single sign-on such that a user can log in once and access all permitted functions and data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(7) and AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.25<\/b> The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-4 and IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.26<\/b> The system shall prevent the same combination of identification components from being used across more than one account.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5 and IA-5(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.27<\/b> The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(3)<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-4 and IA-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PS-4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.28<\/b> The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.29<\/b> The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.30<\/b> The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.31<\/b> The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.32<\/b> The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.33<\/b> The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188 (b-11)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (a-7 and a-8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (c-10)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.34<\/b> The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.35<\/b> The system shall support the ability to initially assign new individual users to system groups, roles, or both.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.36<\/b> The system shall force a user's electronic signature to be unique and traceable to a specific user's account.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>32.37<\/b> The system shall prevent the reuse or reassignment of a user's electronic signature.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.50\" target=\"_blank\">21 CFR Part 11.50<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.38<\/b> When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-26<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.39<\/b> The system should provide a means to migrate static data into the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5(1)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.40<\/b> The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.41<\/b> The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"33._System_validation_and_commission\">33. System validation and commission<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.1<\/b> The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(2)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.2<\/b> The vendor should be willing to provide access to source code through a suitable escrow.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.3<\/b> The system should be able to document a summary and evaluation of enterprise performance markers and processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>33.4<\/b> The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>33.5<\/b> The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.3\u20137<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.6<\/b> The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"34._System_administration\">34. System administration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-11 and AC-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.1<\/b> The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.2<\/b> The system should provide a means for modifying personnel data in a batch.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.3<\/b> The system should support the storage of standard and industry-specific data formats.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(7) and AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2 and IA-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PS-4 and PS-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 5.4 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.4<\/b> The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.5<\/b> The vendor should provide maintenance agreements and support services for its applications and services.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-9<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.6<\/b> The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D-5\u2013D-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MP-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.7<\/b> The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.8<\/b> The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.9<\/b> The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2(5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.10<\/b> The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.11<\/b> The system shall provide a means for migrating data to a new release upon system upgrade.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-13<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.12<\/b> The system should be expedient with the retrieval of stored items.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.13<\/b> The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.14<\/b> The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-15<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-3(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.15<\/b> The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"35._Cybersecurity\">35. Cybersecurity<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-9)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-4-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.8.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>35.1<\/b> The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-4-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-13 and SC-28(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>35.2<\/b> The system should support database encryption and be capable of recording the encryption status of the data contained within.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-2(1\u20134), and IA-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>35.3<\/b> The system should be able to support multifactor authentication.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.202\" target=\"_blank\">45 CFR Part 170.202<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (h)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>35.4<\/b> The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>35.5<\/b> The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-15<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>35.6<\/b> The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"36._Information_privacy\">36. Information privacy<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-E\" target=\"_blank\">45 CFR Part 164 Subpart E<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G17.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-5-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.1<\/b> The system shall comply with privacy protection compliance like that found in HIPAA provisions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2106\" target=\"_blank\">10 CFR Part 20.2106 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.105\" target=\"_blank\">45 CFR Part 164.105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-C\" target=\"_blank\">45 CFR Part 164 Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-5-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 2.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>36.2<\/b> The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>36.3<\/b> The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-E\" target=\"_blank\">45 CFR Part 164 Subpart E<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>36.4<\/b> The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-19(7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.5<\/b> The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173546\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.060 seconds\nReal time usage: 0.064 seconds\nPreprocessor visited node count: 478\/1000000\nPost\u2010expand include size: 78225\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 13.410 1 -total\n 20.15% 2.702 1 Template:LIMSpec\/Configuration_management\n 15.95% 2.139 1 Template:LIMSpec\/System_validation_and_commission\n 15.72% 2.108 1 Template:LIMSpec\/Data_integrity\n 14.72% 1.974 1 Template:LIMSpec\/System_administration\n 13.47% 1.807 1 Template:LIMSpec\/Information_privacy\n 13.26% 1.778 1 Template:LIMSpec\/Cybersecurity\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11215-0!canonical and timestamp 20221202173546 and revision id 36393. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#36._Information_privacy\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#36._Information_privacy<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","111b080aebf48e07f19c5b0f8f2b6a2e_images":[],"111b080aebf48e07f19c5b0f8f2b6a2e_timestamp":1670002547,"46f38a22c13a626b571bac684fbf12ae_type":"article","46f38a22c13a626b571bac684fbf12ae_title":"35. Cybersecurity","46f38a22c13a626b571bac684fbf12ae_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#35._Cybersecurity","46f38a22c13a626b571bac684fbf12ae_plaintext":"\n\nLII:LIMSpec\/Security and Integrity of Systems and OperationsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.\n\n31. Data integrity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-17-1\r\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\nWHO Technical Report Series, #996, Annex 5, 9.1\n\n31.1 System functionality should support ALCOA principles.\n\n\n\n61 FR 38806, 9 CFR Part 417.5\r\n\nASTM E1578-18 E-17-2\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nA2LA C211 4.13.2.3\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nNIST 800-53, Rev. 5, SI-12\n\n\n31.2 The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.\n\n\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 58.190\r\n\n42 CFR Part 93.305\r\n\n42 CFR Part 93.310\r\n\nASTM E1578-18 E-17-3\r\n\nCLSI QMS22 2.2.2.2\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\r\n\nNIST 800-53, Rev. 5, SI-12\r\n\nOECD GLP Principles 10\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\r\n\nUSDA Data and Instrumentation for PDP 8.1.3\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n\n31.3 The system shall securely maintain a true, readable copy of an instrument's original (raw) data for on-demand review.\n\n\n\n7 CFR Part 91.30\r\n\n7 CFR Part 331.17 (c)\r\n\n9 CFR Part 2.35\r\n\n9 CFR Part 121.17 (c)\r\n\n10 CFR Part 20.2103\u201310\r\n\n10 CFR Part 30.34 (g)\r\n\n10 CFR Part 30.51\u20132\r\n\n21 CFR Part 1.1154 (a)\r\n\n21 CFR Part 11.10 (c)\r\n\n21 CFR Part 58.195\r\n\n21 CFR Part 106.100 (n)\r\n\n21 CFR Part 112.164\r\n\n21 CFR Part 114.100 (e)\r\n\n21 CFR Part 117.315\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.9\r\n\n21 CFR Part 129.80 (h)\r\n\n21 CFR Part 211.180\r\n\n21 CFR Part 212.110 (c)\r\n\n21 CFR Part 225.42 (b-8)\r\n\n21 CFR Part 225.58 (c\u2013d)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 225.110\r\n\n21 CFR Part 225.158\r\n\n21 CFR Part 225.202\r\n\n21 CFR Part 226.42 (a)\r\n\n21 CFR Part 226.58 (f)\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 226.115\r\n\n21 CFR Part 312.57\r\n\n21 CFR Part 312.62\r\n\n21 CFR Part 507.208\r\n\n21 CFR Part 606.160 (d)\r\n\n21 CFR Part 812.140 (d)\r\n\n21 CFR Part 820.180 (b)\r\n\n29 CFR Part 1910.120 (f)(8)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n40 CFR Part 141.33\r\n\n40 CFR Part 141.722\r\n\n40 CFR Part 262.11 (f)\r\n\n40 CFR Part 262.40\r\n\n40 CFR Part 262.213\r\n\n40 CFR Part 704 Subpart A\r\n\n40 CFR Part 717.15 (d)\r\n\n42 CFR Part 73.17 (c)\r\n\n42 CFR Part 93.313 (h)\r\n\n42 CFR Part 93.317\r\n\n42 CFR Part 493.1105\r\n\n42 CFR Part 493.1283\r\n\n45 CFR Part 164.105\r\n\n45 CFR Part 164.316\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\n61 FR 38806, 9 CFR Part 417.5\r\n\nA2LA C223 5.4\r\n\nA2LA C223 5.9\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.1.2\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.2.1\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.3.2\r\n\nABFT Accreditation Manual Sec. E-33\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.6\r\n\nACMG Technical Standards for Clinical Genetics Laboratories E2.1\r\n\nAIHA-LAP Policies 2022 2A.7.5.1\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7\r\n\nASTM E1578-18 E-17-4\r\n\nBRC GSFS, Issue 8, 3.3.2\r\n\nCAP Laboratory Accreditation Manual\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.3.4\r\n\nCJIS Security Policy 5.4.6\u20137\r\n\nCJIS Security Policy 5.5.2.1\r\n\nCLSI QMS22 2.8.3\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.4\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nE.U. Annex 11-7.1\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.1\r\n\nE.U. Commission Directive 2003\/94\/EC Article 11.4\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c\r\n\nEPA 815-R-05-004 Chap. III, Sec. 15\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nEPA ERLN Laboratory Requirements 4.9.18\r\n\nEPA ERLN Laboratory Requirements 4.11.17\r\n\nEPA QA\/G-5 2.1.9\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3\r\n\nICH GCP 4.9.5\r\n\nIFS Food 7, Part 2, 2.1.2.2\r\n\nIFS PACsecure 2, Part 2, 2.1.2.2\r\n\nISO 15189:2012 4.3\r\n\nISO\/IEC 17025:2017 8.4.2\r\n\nNIST 800-53, Rev. 5, AT-4\r\n\nNIST 800-53, Rev. 5, AU-11 and AU-11(1)\r\n\nNIST 800-53, Rev. 5, SI-12\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 10\r\n\nOSHA 1910.1020(d)(1)(i\u2013ii)\r\n\nOSHA 1910.1450(j)(2)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.2.3.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP 5.4\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c\r\n\nUSDA Sampling Procedures for PDP 6.5\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0\r\n\nWHO Technical Report Series, #986, Annex 2, 15.8\u20139\r\n\nWHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1\n\n\n31.4 The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.\n\n\nASTM E1578-18 E-17-6\r\nCJIS Security Policy 5.4.4\r\nNIST 800-53, Rev. 5, AU-8\r\nWHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n31.5 The system shall accurately reflect the system date and time in its use of electronic record time stamps.\n\n\nAPHL 2019 LIS Project Management Guidebook\r\nASTM E1578-18 E-17-7\r\nCJIS Security Policy 5.6.1\n\n31.6 The system shall require each and every user to be assigned a unique user ID.\n\n\n\nASTM E1578-18 E-17-8\r\n\n21 CFR Part 11.10 (e)\r\n\nCJIS Security Policy 5.4.5\r\n\nE.U. Annex 11-9\r\n\nNIST 800-53, Rev. 5, AU-9\n\n\n31.7 The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.\n\n\nCJIS Security Policy 5.4.2\r\nNIST 800-53, Rev. 5, AU-5\r\nNIST 800-53, Rev. 5, SI-4\n\n31.8 The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.\n\n\n\n32. Configuration management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 S-1-1\r\nAPHL 2019 LIS Project Management Guidebook\n\n32.1 The system shall provide tools to enter and manage user-configurable lookup or master data.\n\n\nASTM E1578-18 S-1-2\n\n32.2 The system shall allow authorized users to configure the specification limits for sample and instrument tests.\n\n\n45 CFR Part 162.1002\r\nUSDA Sampling Procedures for PDP 6.3.2\n\n32.3 The system shall allow system nomenclature to be configured to use specific data code sets\u2014such as the International Classification of Diseases or the Healthcare Common Procedure Coding System\u2014or mandated terminology to support regulatory requirements.\n\n\nASTM E1578-18 S-1-3\n\n32.4 The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.\n\n\nASTM E1578-18 S-1-4\n\n32.5 The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.\n\n\n21 CFR Part 211.100 (b)\r\n21 CFR Part 211.160 (a)\n\n32.6 The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.\n\n\n\n40 CFR Part 3.10\r\n\n40 CFR Part 3.2000\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C13.3\r\n\nASTM E1578-18 S-1-5\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.7 The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.\n\n\nASTM E1578-18 S-1-6\n\n32.8 The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.\n\n\nASTM E1578-18 S-1-7\n\n32.9 The system shall support configurable laboratory workflows based on appropriate laboratory process and procedure.\n\n\nASTM E1578-18 S-1-8\n\n32.10 The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of laboratory workflow.\n\n\n21 CFR Part 211.68\r\nAPHL 2019 LIS Project Management Guidebook\r\nASTM E1578-18 S-1-9\n\n32.11 The system should allow authorized personnel to perform revision control of lookup or master data.\n\n\nASTM E1578-18 S-1-10\r\nAPHL 2019 LIS Project Management Guidebook\n\n32.12 The system should provide a means for importing lookup or master data.\n\n\n\nAIHA-LAP Policies 2022 2A.7.8.4\r\n\nASTM E1578-18 S-1-11\r\n\nEPA ERLN Laboratory Requirements 4.11.6\r\n\nUSDA Data and Instrumentation for PDP 9.1\n\n\n32.13 The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.\n\n\nASTM E1578-18 S-1-12\n\n32.14 The system should allow calculated limits to be created and managed based on test results and relevant metadata.\n\n\nASTM E1578-18 S-1-13\r\nEPA ERLN Laboratory Requirements 3.2.6\r\nEPA ERLN Laboratory Requirements 4.9.11\n\n32.15 The system should provide a clear alert or notification upon entry of out-of-specification results.\n\n\nASTM E1578-18 S-1-14\n\n32.16 The system shall allow authorized personnel to update static and dynamic data.\n\n\nASTM E1578-18 S-1-15\n\n32.17 The system should allow workflow events and status changes to trigger one or more user-defined actions.\n\n\nASTM E1578-18 S-1-17\r\n\nCJIS Security Policy 5.7.1\r\n\nNIST 800-53, Rev. 5, AC-6(1)\r\n\nNIST 800-53, Rev. 5, CM-7\n\n\n32.18 The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.\n\n\nASTM E1578-18 S-1-18\r\nCAP Laboratory Accreditation Manual\n\n32.19 The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.\n\n\nASTM E1578-18 S-1-19\n\n32.20 The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.\n\n\n21 CFR Part 11.100 (a)\r\n\nASTM E1578-18 S-1-20\r\n\nE.U. Annex 11-14\r\n\nNIST 800-53, Rev. 5, CM-5(1)\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.21 The system should support rules governing electronic records and electronic signatures in regulated environments.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n10 CFR Part 20.2110\r\n\n10 CFR Part 30.51 (c-1\r\n\n21 CFR Part 11.10 (d)\r\n\n21 CFR Part 211.68\r\n\n42 CFR Part 73.11\r\n\n45 CFR Part 164.308\r\n\nA2LA C211 4.13.1.4\r\n\nA2LA C211 5.4.7.2\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.4.1\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\nASTM E1492-11 4.2.4\r\n\nASTM E1578-18 S-1-16\r\n\nASTM E1578-18 S-1-21\r\n\nCJIS Security Policy 5.5.2\r\n\nCLSI QMS22 2.4.3\r\n\nE.U. Annex 11-12\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nEPA ERLN Laboratory Requirements 4.9.4 and 4.9.14\r\n\nICH GCP 2.10\r\n\nISO\/IEC 17025:2017 7.11.3\r\n\nNIST 800-53, Rev. 5, CM-5 and CM-5(1)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\n\n\n32.22 The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.\n\n\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nCJIS Security Policy 5.5.2.2\u20133\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nNIST 800-53, Rev. 5, AC-2(11)\n\n\n32.23 The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.\n\n\nASTM E1578-18 S-1-22\r\nNIST 800-53, Rev. 5, IA-2(10)\n\n32.24 The system should support single sign-on such that a user can log in once and access all permitted functions and data.\n\n\n\n21 CFR Part 11.200 (a)\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d)\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCJIS Security Policy 5.6.1\r\n\nCLSI QMS22 2.4.2.2\r\n\nE.U. Annex 11-14\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nEPA ERLN Laboratory Requirements 4.9.4\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\nNIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\r\n\nNIST 800-53, Rev. 5, MA-4\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.25 The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.\n\n\n\n21 CFR Part 11.300 (a)\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, IA-4 and IA-5\n\n\n32.26 The system shall prevent the same combination of identification components from being used across more than one account.\n\n\n\n21 CFR Part 11.300 (b)\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCLSI QMS22 2.4.2\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, IA-5 and IA-5(1)\n\n\n32.27 The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.\n\n\nCJIS Security Policy 5.6.3.1\r\nNIST 800-53, Rev. 5, AC-2(3)\r\n\nNIST 800-53, Rev. 5, IA-4 and IA-5(1)\r\n\nNIST 800-53, Rev. 5, PS-4\n\n\n32.28 The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.\n\n\nCJIS Security Policy 5.5.2.2\r\nNIST 800-53, Rev. 5, AC-10\n\n32.29 The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.\n\n\nCJIS Security Policy 5.5.4\r\nNIST 800-53, Rev. 5, AC-8\n\n32.30 The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.\n\n\n\n21 CFR Part 11.300 (d)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\nA2LA C211 4.13.2.1\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCLSI QMS22 2.4.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, CM-5(1)\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\n\n\n32.31 The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.\n\n\n\n21 CFR Part 11.300 (d)\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCJIS Security Policy 5.5.3\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, AC-7\n\n\n32.32 The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.\n\n\n21 CFR Part 11.200 (a)\r\nASTM E1578-18 S-3-1\n\n32.33 The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.200 (a)\r\n\n21 CFR Part 211.68 (b)\r\n\n21 CFR Part 211.188 (b-11)\r\n\n21 CFR Part 211.194 (a-7 and a-8)\r\n\n21 CFR Part 212.50 (c-10)\r\n\n42 CFR Part 73.11\r\n\nASTM E1578-18 S-3-1\r\n\nCJIS Security Policy 5.6.3.2\r\n\nNIST 800-53, Rev. 5, IA-5\n\n\n32.34 The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.10 (d)\r\n\n42 CFR Part 73.11\r\n\n42 CFR Part 493.1231\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.514\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 S-1-25\r\n\nCJIS Security Policy 5.5.1\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nNIST 800-53, Rev. 5, AC-3\r\n\nNIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\n\n\n32.35 The system shall support the ability to initially assign new individual users to system groups, roles, or both.\n\n\n\n21 CFR Part 11.100 (a)\r\n\n45 CFR Part 164.312\r\n\nASTM E1578-18 S-1-24\r\n\nE.U. Annex 11-14\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.36 The system shall force a user's electronic signature to be unique and traceable to a specific user's account.\n\n\n21 CFR Part 11.100 (a)\r\nASTM E1578-18 S-1-24\r\n\n\n32.37 The system shall prevent the reuse or reassignment of a user's electronic signature.\n\n\n21 CFR Part 11.50\r\nE.U. Annex 11-14\n\n32.38 When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.\n\n\n\nASTM E1578-18 S-1-26\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nCLSI QMS22 2.8.5.3\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.39 The system should provide a means to migrate static data into the system.\n\n\nNIST 800-53, Rev. 5, IA-5(1)\r\nCLSI QMS22 2.4.2\n\n32.40 The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.\n\n\nNIST 800-53, Rev. 5, IA-6\n\n32.41 The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.\n\n\n\n33. System validation and commission \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 S-2-1\r\nCJIS Security Policy Appendix G.8\r\nNIST 800-53, Rev. 5, SA-4(3)\n\n33.1 The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.\n\n\nASTM E1578-18 S-2-2\r\nNIST 800-53, Rev. 5, SA-4(2)\n\n33.2 The vendor should be willing to provide access to source code through a suitable escrow.\n\n\nASTM E1578-18 S-2-3\n\n33.3 The system should be able to document a summary and evaluation of enterprise performance markers and processes.\n\n\n\nA2LA C211 5.4.7.2\r\n\nASTM E1578-18 S-2-4\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 7.11.5\r\n\nNIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5\n\n\n33.4 The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.\n\n\n\n21 CFR Part 11.10 (a)\r\n\n21 CFR Part 820.70 (i)\r\n\nA2LA C211 5.4.7.2\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nE.U. Annex 11-11\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 7.11.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 4.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)\r\n\nWHO Technical Report Series, #996, Annex 5, 10.2\n\n\n33.5 The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.\n\n\nASTM E1578-18 S-2-2\r\nCLSI QMS22 2.5\r\nE.U. Annex 11-4\r\nWHO Technical Report Series, #996, Annex 5, 10.3\u20137\n\n33.6 The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.\n\n\n\n34. System administration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 11.200 (a)\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d-5)\r\n\nASTM E1578-18 S-3-1\r\n\nCJIS Security Policy 5.5.5\r\n\nCLSI QMS22 2.4.2\r\n\nNIST 800-53, Rev. 5, AC-11 and AC-12\n\n\n34.1 The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.\n\n\nASTM E1578-18 S-3-2\n\n34.2 The system should provide a means for modifying personnel data in a batch.\n\n\nASTM E1578-18 S-3-3\n\n34.3 The system should support the storage of standard and industry-specific data formats.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.10 (d)\r\n\n21 CFR Part 211.68 (b)\r\n\n42 CFR Part 73.11\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.514\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 S-3-7\r\n\nCJIS Security Policy 5.5.1\r\n\nCJIS Security Policy 5.5.2.4\r\n\nCJIS Security Policy Appendix G.5\r\n\nCLSI QMS22 2.4.2\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nISO 15189:2012 5.10.2\r\n\nNIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\nNIST 800-53, Rev. 5, IA-2 and IA-8\r\n\nNIST 800-53, Rev. 5, MA-4\r\n\nNIST 800-53, Rev. 5, PS-4 and PS-5\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Administrative Procedures for the PDP 5.5.1.2\r\n\nWHO Technical Report Series, #996, Annex 5, 5.4 and Appendix 1\n\n\n34.4 The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.\n\n\nASTM E1578-18 S-3-8\n\n34.5 The vendor should provide maintenance agreements and support services for its applications and services.\n\n\nASTM E1578-18 S-3-9\r\n\nE.U. Annex 11-3.3\r\n\nNIST 800-53, Rev. 5, SA-16\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\n\n\n34.6 The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.10 (c)\r\n\n42 CFR Part 73.11\r\n\n45 CFR Part 164.310\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.4.3\r\n\nABFT Accreditation Manual Sec. D-5\u2013D-8\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\nASTM E1492-11 4.2.4\r\n\nCJIS Security Policy 5.5.2\r\n\nCJIS Security Policy 5.8.1\r\n\nEPA ERLN Laboratory Requirements 4.9.6\r\n\nE.U. Annex 11-7.1\r\n\nE.U. Annex 11-12\r\n\nISO 15189:2012 5.10.2\r\n\nISO\/IEC 17025:2017 7.11.3\r\n\nNIST 800-53, Rev. 5, MA-5\r\n\nNIST 800-53, Rev. 5, MP-2\r\n\nNIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\n\n\n34.7 The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)\n\n\nCJIS Security Policy 5.5.1\n\n34.8 The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n42 CFR Part 73.17\r\n\nASTM E1578-18 S-3-10\n\n\n34.9 The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n42 CFR Part 73.11\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 S-3-11\r\n\nCJIS Security Policy 5.10.4.1\r\n\nCLSI QMS22 2.1.4\r\n\nCLSI QMS22 2.6.1\r\n\nEPA ERLN Laboratory Requirements 4.9.13\r\n\nNIST 800-53, Rev. 5, SI-2(5)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n34.10 The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.\n\n\nASTM E1578-18 S-3-12\n\n34.11 The system shall provide a means for migrating data to a new release upon system upgrade.\n\n\n21 CFR Part 1.1154 (b)\r\nASTM E1578-18 S-3-13\n\n34.12 The system should be expedient with the retrieval of stored items.\n\n\n\n21 CFR Part 11.10 (b)\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nE.U. Annex 11-5\r\n\nE.U. Annex 11-8.1\n\n\n34.13 The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.\n\n\nASTM E1578-18 S-3-14\n\n34.14 The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.\n\n\nASTM E1578-18 S-3-15\r\n\nEPA ERLN Laboratory Requirements 4.9.13\r\n\nNIST 800-53, Rev. 5, CM-3(2)\r\n\nNIST 800-53, Rev. 5, SI-2\n\n\n34.15 The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.\n\n\n\n35. Cybersecurity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n42 CFR Part 493.1231\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d-9)\r\n\nASTM E1578-18 S-4-1\r\n\nCJIS Security Policy 5.6.4\r\n\nCJIS Security Policy 5.8.2.1\r\n\nCJIS Security Policy 5.10.1.2\r\n\nCJIS Security Policy Appendix G.6\r\n\nCLSI QMS22 2.2.3.2\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nNIST 800-53, Rev. 5, AC-17(2)\n\n\n35.1 The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.\n\n\n\n42 CFR Part 493.1231\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d)\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.6\r\n\nASTM E1578-18 S-4-2\r\n\nCJIS Security Policy 5.5.2.4\r\n\nCJIS Security Policy 5.10.1.2\r\n\nCJIS Security Policy Appendix G.6\r\n\nNIST 800-53, Rev. 5, SC-13 and SC-28(1)\n\n\n35.2 The system should support database encryption and be capable of recording the encryption status of the data contained within.\n\n\n42 CFR Part 493.1231\r\n\nCJIS Security Policy 5.6.2.2.1\r\n\nCLSI QMS22 2.4.2.2\r\n\nNIST 800-53, Rev. 5, AC-3\r\n\nNIST 800-53, Rev. 5, IA-2, IA-2(1\u20134), and IA-8\r\n\nNIST 800-53, Rev. 5, MA-4\n\n\n35.3 The system should be able to support multifactor authentication.\n\n\n45 CFR Part 170.202\r\n45 CFR Part 170.315 (h)\n\n35.4 The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information.\n\n\nNIST 800-53, Rev. 5, IA-7\n\n35.5 The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.\n\n\nNIST 800-53, Rev. 5, SC-15\n\n35.6 The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.\n\n\n\n36. Information privacy \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n45 CFR Part 164 Subpart E\r\nACMG Technical Standards for Clinical Genetics Laboratories G17.2\r\nASTM E1578-18 S-5-1\r\nCAP Laboratory Accreditation Manual\n\n36.1 The system shall comply with privacy protection compliance like that found in HIPAA provisions.\n\n\n\n10 CFR Part 20.2106 (d)\r\n\n45 CFR Part 164.105\r\n\n45 CFR Part 164 Subpart C\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 S-5-2\r\n\nICH GCP 2.11\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.3\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\n\n\n36.2 The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.\n\n\n45 CFR Part 164.514\r\nACMG Technical Standards for Clinical Genetics Laboratories C5.5\r\nCAP Laboratory Accreditation Manual\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3\n\n\n36.3 The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.\n\n\n45 CFR Part 164 Subpart E\r\n\nNIST 800-53, Rev. 5, AC-6\n\n\n36.4 The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.\n\n\nNIST 800-53, Rev. 5, SI-19(7)\n\n36.5 The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#35._Cybersecurity\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#35._Cybersecurity<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 20 September 2019, at 18:12.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 1,950 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","46f38a22c13a626b571bac684fbf12ae_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Security_and_Integrity_of_Systems_and_Operations rootpage-LII_LIMSpec_Security_and_Integrity_of_Systems_and_Operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Security and Integrity of Systems and Operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"31._Data_integrity\">31. Data integrity<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 9.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.1<\/b> System functionality should support ALCOA principles.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.2<\/b> The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.305\" target=\"_blank\">42 CFR Part 93.305<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.310\" target=\"_blank\">42 CFR Part 93.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.3<\/b> The system shall securely maintain a true, readable copy of an instrument's original (raw) data for on-demand review.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.30\" target=\"_blank\">7 CFR Part 91.30<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.195\" target=\"_blank\">21 CFR Part 58.195<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (n)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.164<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.180\" target=\"_blank\">21 CFR Part 211.180<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 212.110 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42 (b-8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (c\u2013d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.202\" target=\"_blank\">21 CFR Part 225.202<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.115\" target=\"_blank\">21 CFR Part 226.115<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.208<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.160\" target=\"_blank\">21 CFR Part 606.160 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.180\" target=\"_blank\">21 CFR Part 820.180 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120 (f)(8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.722\" target=\"_blank\">40 CFR Part 141.722<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.11\" target=\"_blank\">40 CFR Part 262.11 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.40\" target=\"_blank\">40 CFR Part 262.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.213\" target=\"_blank\">40 CFR Part 262.213<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\/subpart-A\" target=\"_blank\">40 CFR Part 704 Subpart A<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/717.15\" target=\"_blank\">40 CFR Part 717.15 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.313\" target=\"_blank\">42 CFR Part 93.313 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.317\" target=\"_blank\">42 CFR Part 93.317<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1105\" target=\"_blank\">42 CFR Part 493.1105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.105\" target=\"_blank\">45 CFR Part 164.105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.316\" target=\"_blank\">45 CFR Part 164.316<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories E2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.4<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.18<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 2.1.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 2.1.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-11 and AU-11(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020(d)(1)(i\u2013ii)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(j)(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.8\u20139<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.4<\/b> The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.5<\/b> The system shall accurately reflect the system date and time in its use of electronic record time stamps.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-7<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.6<\/b> The system shall require each and every user to be assigned a unique user ID.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.7<\/b> The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.8<\/b> The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"32._Configuration_management\">32. Configuration management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.1<\/b> The system shall provide tools to enter and manage user-configurable lookup or master data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.2<\/b> The system shall allow authorized users to configure the specification limits for sample and instrument tests.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/162.1002\" target=\"_blank\">45 CFR Part 162.1002<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.3.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.3<\/b> The system shall allow system nomenclature to be configured to use specific data code sets\u2014such as the International Classification of Diseases or the Healthcare Common Procedure Coding System\u2014or mandated terminology to support regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.4<\/b> The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.5<\/b> The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.6<\/b> The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.10\" target=\"_blank\">40 CFR Part 3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.2000\" target=\"_blank\">40 CFR Part 3.2000<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C13.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.7<\/b> The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.8<\/b> The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.9<\/b> The system shall support configurable laboratory workflows based on appropriate laboratory process and procedure.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.10<\/b> The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of laboratory workflow.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.11<\/b> The system should allow authorized personnel to perform revision control of lookup or master data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-10<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.12<\/b> The system should provide a means for importing lookup or master data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 9.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.13<\/b> The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.14<\/b> The system should allow calculated limits to be created and managed based on test results and relevant metadata.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-13<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.15<\/b> The system should provide a clear alert or notification upon entry of out-of-specification results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.16<\/b> The system shall allow authorized personnel to update static and dynamic data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-15<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.17<\/b> The system should allow workflow events and status changes to trigger one or more user-defined actions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-17<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.18<\/b> The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-18<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.19<\/b> The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-19<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.20<\/b> The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.21<\/b> The system should support rules governing electronic records and electronic signatures in regulated environments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2110\" target=\"_blank\">10 CFR Part 20.2110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51 (c-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4 and 4.9.14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5 and CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.22<\/b> The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(11)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.23<\/b> The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-22<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2(10)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.24<\/b> The system should support single sign-on such that a user can log in once and access all permitted functions and data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(7) and AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.25<\/b> The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-4 and IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.26<\/b> The system shall prevent the same combination of identification components from being used across more than one account.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5 and IA-5(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.27<\/b> The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(3)<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-4 and IA-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PS-4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.28<\/b> The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.29<\/b> The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.30<\/b> The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.31<\/b> The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.32<\/b> The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.33<\/b> The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188 (b-11)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (a-7 and a-8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (c-10)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.34<\/b> The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.35<\/b> The system shall support the ability to initially assign new individual users to system groups, roles, or both.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.36<\/b> The system shall force a user's electronic signature to be unique and traceable to a specific user's account.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>32.37<\/b> The system shall prevent the reuse or reassignment of a user's electronic signature.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.50\" target=\"_blank\">21 CFR Part 11.50<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.38<\/b> When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-26<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.39<\/b> The system should provide a means to migrate static data into the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5(1)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.40<\/b> The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.41<\/b> The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"33._System_validation_and_commission\">33. System validation and commission<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.1<\/b> The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(2)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.2<\/b> The vendor should be willing to provide access to source code through a suitable escrow.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.3<\/b> The system should be able to document a summary and evaluation of enterprise performance markers and processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>33.4<\/b> The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>33.5<\/b> The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.3\u20137<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.6<\/b> The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"34._System_administration\">34. System administration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-11 and AC-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.1<\/b> The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.2<\/b> The system should provide a means for modifying personnel data in a batch.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.3<\/b> The system should support the storage of standard and industry-specific data formats.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(7) and AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2 and IA-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PS-4 and PS-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 5.4 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.4<\/b> The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.5<\/b> The vendor should provide maintenance agreements and support services for its applications and services.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-9<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.6<\/b> The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D-5\u2013D-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MP-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.7<\/b> The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.8<\/b> The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.9<\/b> The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2(5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.10<\/b> The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.11<\/b> The system shall provide a means for migrating data to a new release upon system upgrade.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-13<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.12<\/b> The system should be expedient with the retrieval of stored items.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.13<\/b> The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.14<\/b> The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-15<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-3(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.15<\/b> The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"35._Cybersecurity\">35. Cybersecurity<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-9)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-4-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.8.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>35.1<\/b> The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-4-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-13 and SC-28(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>35.2<\/b> The system should support database encryption and be capable of recording the encryption status of the data contained within.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-2(1\u20134), and IA-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>35.3<\/b> The system should be able to support multifactor authentication.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.202\" target=\"_blank\">45 CFR Part 170.202<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (h)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>35.4<\/b> The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>35.5<\/b> The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-15<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>35.6<\/b> The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"36._Information_privacy\">36. Information privacy<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-E\" target=\"_blank\">45 CFR Part 164 Subpart E<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G17.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-5-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.1<\/b> The system shall comply with privacy protection compliance like that found in HIPAA provisions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2106\" target=\"_blank\">10 CFR Part 20.2106 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.105\" target=\"_blank\">45 CFR Part 164.105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-C\" target=\"_blank\">45 CFR Part 164 Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-5-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 2.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>36.2<\/b> The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>36.3<\/b> The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-E\" target=\"_blank\">45 CFR Part 164 Subpart E<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>36.4<\/b> The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-19(7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.5<\/b> The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173546\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.060 seconds\nReal time usage: 0.064 seconds\nPreprocessor visited node count: 478\/1000000\nPost\u2010expand include size: 78225\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 13.410 1 -total\n 20.15% 2.702 1 Template:LIMSpec\/Configuration_management\n 15.95% 2.139 1 Template:LIMSpec\/System_validation_and_commission\n 15.72% 2.108 1 Template:LIMSpec\/Data_integrity\n 14.72% 1.974 1 Template:LIMSpec\/System_administration\n 13.47% 1.807 1 Template:LIMSpec\/Information_privacy\n 13.26% 1.778 1 Template:LIMSpec\/Cybersecurity\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11215-0!canonical and timestamp 20221202173546 and revision id 36393. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#35._Cybersecurity\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#35._Cybersecurity<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","46f38a22c13a626b571bac684fbf12ae_images":[],"46f38a22c13a626b571bac684fbf12ae_timestamp":1670002547,"4e61932b867065094a0b64f809b55574_type":"article","4e61932b867065094a0b64f809b55574_title":"34. System administration","4e61932b867065094a0b64f809b55574_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#34._System_administration","4e61932b867065094a0b64f809b55574_plaintext":"\n\nLII:LIMSpec\/Security and Integrity of Systems and OperationsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.\n\n31. Data integrity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-17-1\r\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\nWHO Technical Report Series, #996, Annex 5, 9.1\n\n31.1 System functionality should support ALCOA principles.\n\n\n\n61 FR 38806, 9 CFR Part 417.5\r\n\nASTM E1578-18 E-17-2\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nA2LA C211 4.13.2.3\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nNIST 800-53, Rev. 5, SI-12\n\n\n31.2 The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.\n\n\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 58.190\r\n\n42 CFR Part 93.305\r\n\n42 CFR Part 93.310\r\n\nASTM E1578-18 E-17-3\r\n\nCLSI QMS22 2.2.2.2\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\r\n\nNIST 800-53, Rev. 5, SI-12\r\n\nOECD GLP Principles 10\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\r\n\nUSDA Data and Instrumentation for PDP 8.1.3\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n\n31.3 The system shall securely maintain a true, readable copy of an instrument's original (raw) data for on-demand review.\n\n\n\n7 CFR Part 91.30\r\n\n7 CFR Part 331.17 (c)\r\n\n9 CFR Part 2.35\r\n\n9 CFR Part 121.17 (c)\r\n\n10 CFR Part 20.2103\u201310\r\n\n10 CFR Part 30.34 (g)\r\n\n10 CFR Part 30.51\u20132\r\n\n21 CFR Part 1.1154 (a)\r\n\n21 CFR Part 11.10 (c)\r\n\n21 CFR Part 58.195\r\n\n21 CFR Part 106.100 (n)\r\n\n21 CFR Part 112.164\r\n\n21 CFR Part 114.100 (e)\r\n\n21 CFR Part 117.315\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.9\r\n\n21 CFR Part 129.80 (h)\r\n\n21 CFR Part 211.180\r\n\n21 CFR Part 212.110 (c)\r\n\n21 CFR Part 225.42 (b-8)\r\n\n21 CFR Part 225.58 (c\u2013d)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 225.110\r\n\n21 CFR Part 225.158\r\n\n21 CFR Part 225.202\r\n\n21 CFR Part 226.42 (a)\r\n\n21 CFR Part 226.58 (f)\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 226.115\r\n\n21 CFR Part 312.57\r\n\n21 CFR Part 312.62\r\n\n21 CFR Part 507.208\r\n\n21 CFR Part 606.160 (d)\r\n\n21 CFR Part 812.140 (d)\r\n\n21 CFR Part 820.180 (b)\r\n\n29 CFR Part 1910.120 (f)(8)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n40 CFR Part 141.33\r\n\n40 CFR Part 141.722\r\n\n40 CFR Part 262.11 (f)\r\n\n40 CFR Part 262.40\r\n\n40 CFR Part 262.213\r\n\n40 CFR Part 704 Subpart A\r\n\n40 CFR Part 717.15 (d)\r\n\n42 CFR Part 73.17 (c)\r\n\n42 CFR Part 93.313 (h)\r\n\n42 CFR Part 93.317\r\n\n42 CFR Part 493.1105\r\n\n42 CFR Part 493.1283\r\n\n45 CFR Part 164.105\r\n\n45 CFR Part 164.316\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\n61 FR 38806, 9 CFR Part 417.5\r\n\nA2LA C223 5.4\r\n\nA2LA C223 5.9\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.1.2\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.2.1\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.3.2\r\n\nABFT Accreditation Manual Sec. E-33\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.6\r\n\nACMG Technical Standards for Clinical Genetics Laboratories E2.1\r\n\nAIHA-LAP Policies 2022 2A.7.5.1\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7\r\n\nASTM E1578-18 E-17-4\r\n\nBRC GSFS, Issue 8, 3.3.2\r\n\nCAP Laboratory Accreditation Manual\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.3.4\r\n\nCJIS Security Policy 5.4.6\u20137\r\n\nCJIS Security Policy 5.5.2.1\r\n\nCLSI QMS22 2.8.3\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.4\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nE.U. Annex 11-7.1\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.1\r\n\nE.U. Commission Directive 2003\/94\/EC Article 11.4\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c\r\n\nEPA 815-R-05-004 Chap. III, Sec. 15\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nEPA ERLN Laboratory Requirements 4.9.18\r\n\nEPA ERLN Laboratory Requirements 4.11.17\r\n\nEPA QA\/G-5 2.1.9\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3\r\n\nICH GCP 4.9.5\r\n\nIFS Food 7, Part 2, 2.1.2.2\r\n\nIFS PACsecure 2, Part 2, 2.1.2.2\r\n\nISO 15189:2012 4.3\r\n\nISO\/IEC 17025:2017 8.4.2\r\n\nNIST 800-53, Rev. 5, AT-4\r\n\nNIST 800-53, Rev. 5, AU-11 and AU-11(1)\r\n\nNIST 800-53, Rev. 5, SI-12\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 10\r\n\nOSHA 1910.1020(d)(1)(i\u2013ii)\r\n\nOSHA 1910.1450(j)(2)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.2.3.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP 5.4\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c\r\n\nUSDA Sampling Procedures for PDP 6.5\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0\r\n\nWHO Technical Report Series, #986, Annex 2, 15.8\u20139\r\n\nWHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1\n\n\n31.4 The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.\n\n\nASTM E1578-18 E-17-6\r\nCJIS Security Policy 5.4.4\r\nNIST 800-53, Rev. 5, AU-8\r\nWHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n31.5 The system shall accurately reflect the system date and time in its use of electronic record time stamps.\n\n\nAPHL 2019 LIS Project Management Guidebook\r\nASTM E1578-18 E-17-7\r\nCJIS Security Policy 5.6.1\n\n31.6 The system shall require each and every user to be assigned a unique user ID.\n\n\n\nASTM E1578-18 E-17-8\r\n\n21 CFR Part 11.10 (e)\r\n\nCJIS Security Policy 5.4.5\r\n\nE.U. Annex 11-9\r\n\nNIST 800-53, Rev. 5, AU-9\n\n\n31.7 The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.\n\n\nCJIS Security Policy 5.4.2\r\nNIST 800-53, Rev. 5, AU-5\r\nNIST 800-53, Rev. 5, SI-4\n\n31.8 The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.\n\n\n\n32. Configuration management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 S-1-1\r\nAPHL 2019 LIS Project Management Guidebook\n\n32.1 The system shall provide tools to enter and manage user-configurable lookup or master data.\n\n\nASTM E1578-18 S-1-2\n\n32.2 The system shall allow authorized users to configure the specification limits for sample and instrument tests.\n\n\n45 CFR Part 162.1002\r\nUSDA Sampling Procedures for PDP 6.3.2\n\n32.3 The system shall allow system nomenclature to be configured to use specific data code sets\u2014such as the International Classification of Diseases or the Healthcare Common Procedure Coding System\u2014or mandated terminology to support regulatory requirements.\n\n\nASTM E1578-18 S-1-3\n\n32.4 The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.\n\n\nASTM E1578-18 S-1-4\n\n32.5 The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.\n\n\n21 CFR Part 211.100 (b)\r\n21 CFR Part 211.160 (a)\n\n32.6 The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.\n\n\n\n40 CFR Part 3.10\r\n\n40 CFR Part 3.2000\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C13.3\r\n\nASTM E1578-18 S-1-5\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.7 The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.\n\n\nASTM E1578-18 S-1-6\n\n32.8 The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.\n\n\nASTM E1578-18 S-1-7\n\n32.9 The system shall support configurable laboratory workflows based on appropriate laboratory process and procedure.\n\n\nASTM E1578-18 S-1-8\n\n32.10 The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of laboratory workflow.\n\n\n21 CFR Part 211.68\r\nAPHL 2019 LIS Project Management Guidebook\r\nASTM E1578-18 S-1-9\n\n32.11 The system should allow authorized personnel to perform revision control of lookup or master data.\n\n\nASTM E1578-18 S-1-10\r\nAPHL 2019 LIS Project Management Guidebook\n\n32.12 The system should provide a means for importing lookup or master data.\n\n\n\nAIHA-LAP Policies 2022 2A.7.8.4\r\n\nASTM E1578-18 S-1-11\r\n\nEPA ERLN Laboratory Requirements 4.11.6\r\n\nUSDA Data and Instrumentation for PDP 9.1\n\n\n32.13 The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.\n\n\nASTM E1578-18 S-1-12\n\n32.14 The system should allow calculated limits to be created and managed based on test results and relevant metadata.\n\n\nASTM E1578-18 S-1-13\r\nEPA ERLN Laboratory Requirements 3.2.6\r\nEPA ERLN Laboratory Requirements 4.9.11\n\n32.15 The system should provide a clear alert or notification upon entry of out-of-specification results.\n\n\nASTM E1578-18 S-1-14\n\n32.16 The system shall allow authorized personnel to update static and dynamic data.\n\n\nASTM E1578-18 S-1-15\n\n32.17 The system should allow workflow events and status changes to trigger one or more user-defined actions.\n\n\nASTM E1578-18 S-1-17\r\n\nCJIS Security Policy 5.7.1\r\n\nNIST 800-53, Rev. 5, AC-6(1)\r\n\nNIST 800-53, Rev. 5, CM-7\n\n\n32.18 The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.\n\n\nASTM E1578-18 S-1-18\r\nCAP Laboratory Accreditation Manual\n\n32.19 The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.\n\n\nASTM E1578-18 S-1-19\n\n32.20 The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.\n\n\n21 CFR Part 11.100 (a)\r\n\nASTM E1578-18 S-1-20\r\n\nE.U. Annex 11-14\r\n\nNIST 800-53, Rev. 5, CM-5(1)\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.21 The system should support rules governing electronic records and electronic signatures in regulated environments.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n10 CFR Part 20.2110\r\n\n10 CFR Part 30.51 (c-1\r\n\n21 CFR Part 11.10 (d)\r\n\n21 CFR Part 211.68\r\n\n42 CFR Part 73.11\r\n\n45 CFR Part 164.308\r\n\nA2LA C211 4.13.1.4\r\n\nA2LA C211 5.4.7.2\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.4.1\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\nASTM E1492-11 4.2.4\r\n\nASTM E1578-18 S-1-16\r\n\nASTM E1578-18 S-1-21\r\n\nCJIS Security Policy 5.5.2\r\n\nCLSI QMS22 2.4.3\r\n\nE.U. Annex 11-12\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nEPA ERLN Laboratory Requirements 4.9.4 and 4.9.14\r\n\nICH GCP 2.10\r\n\nISO\/IEC 17025:2017 7.11.3\r\n\nNIST 800-53, Rev. 5, CM-5 and CM-5(1)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\n\n\n32.22 The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.\n\n\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nCJIS Security Policy 5.5.2.2\u20133\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nNIST 800-53, Rev. 5, AC-2(11)\n\n\n32.23 The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.\n\n\nASTM E1578-18 S-1-22\r\nNIST 800-53, Rev. 5, IA-2(10)\n\n32.24 The system should support single sign-on such that a user can log in once and access all permitted functions and data.\n\n\n\n21 CFR Part 11.200 (a)\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d)\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCJIS Security Policy 5.6.1\r\n\nCLSI QMS22 2.4.2.2\r\n\nE.U. Annex 11-14\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nEPA ERLN Laboratory Requirements 4.9.4\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\nNIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\r\n\nNIST 800-53, Rev. 5, MA-4\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.25 The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.\n\n\n\n21 CFR Part 11.300 (a)\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, IA-4 and IA-5\n\n\n32.26 The system shall prevent the same combination of identification components from being used across more than one account.\n\n\n\n21 CFR Part 11.300 (b)\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCLSI QMS22 2.4.2\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, IA-5 and IA-5(1)\n\n\n32.27 The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.\n\n\nCJIS Security Policy 5.6.3.1\r\nNIST 800-53, Rev. 5, AC-2(3)\r\n\nNIST 800-53, Rev. 5, IA-4 and IA-5(1)\r\n\nNIST 800-53, Rev. 5, PS-4\n\n\n32.28 The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.\n\n\nCJIS Security Policy 5.5.2.2\r\nNIST 800-53, Rev. 5, AC-10\n\n32.29 The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.\n\n\nCJIS Security Policy 5.5.4\r\nNIST 800-53, Rev. 5, AC-8\n\n32.30 The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.\n\n\n\n21 CFR Part 11.300 (d)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\nA2LA C211 4.13.2.1\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCLSI QMS22 2.4.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, CM-5(1)\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\n\n\n32.31 The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.\n\n\n\n21 CFR Part 11.300 (d)\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCJIS Security Policy 5.5.3\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, AC-7\n\n\n32.32 The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.\n\n\n21 CFR Part 11.200 (a)\r\nASTM E1578-18 S-3-1\n\n32.33 The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.200 (a)\r\n\n21 CFR Part 211.68 (b)\r\n\n21 CFR Part 211.188 (b-11)\r\n\n21 CFR Part 211.194 (a-7 and a-8)\r\n\n21 CFR Part 212.50 (c-10)\r\n\n42 CFR Part 73.11\r\n\nASTM E1578-18 S-3-1\r\n\nCJIS Security Policy 5.6.3.2\r\n\nNIST 800-53, Rev. 5, IA-5\n\n\n32.34 The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.10 (d)\r\n\n42 CFR Part 73.11\r\n\n42 CFR Part 493.1231\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.514\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 S-1-25\r\n\nCJIS Security Policy 5.5.1\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nNIST 800-53, Rev. 5, AC-3\r\n\nNIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\n\n\n32.35 The system shall support the ability to initially assign new individual users to system groups, roles, or both.\n\n\n\n21 CFR Part 11.100 (a)\r\n\n45 CFR Part 164.312\r\n\nASTM E1578-18 S-1-24\r\n\nE.U. Annex 11-14\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.36 The system shall force a user's electronic signature to be unique and traceable to a specific user's account.\n\n\n21 CFR Part 11.100 (a)\r\nASTM E1578-18 S-1-24\r\n\n\n32.37 The system shall prevent the reuse or reassignment of a user's electronic signature.\n\n\n21 CFR Part 11.50\r\nE.U. Annex 11-14\n\n32.38 When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.\n\n\n\nASTM E1578-18 S-1-26\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nCLSI QMS22 2.8.5.3\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.39 The system should provide a means to migrate static data into the system.\n\n\nNIST 800-53, Rev. 5, IA-5(1)\r\nCLSI QMS22 2.4.2\n\n32.40 The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.\n\n\nNIST 800-53, Rev. 5, IA-6\n\n32.41 The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.\n\n\n\n33. System validation and commission \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 S-2-1\r\nCJIS Security Policy Appendix G.8\r\nNIST 800-53, Rev. 5, SA-4(3)\n\n33.1 The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.\n\n\nASTM E1578-18 S-2-2\r\nNIST 800-53, Rev. 5, SA-4(2)\n\n33.2 The vendor should be willing to provide access to source code through a suitable escrow.\n\n\nASTM E1578-18 S-2-3\n\n33.3 The system should be able to document a summary and evaluation of enterprise performance markers and processes.\n\n\n\nA2LA C211 5.4.7.2\r\n\nASTM E1578-18 S-2-4\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 7.11.5\r\n\nNIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5\n\n\n33.4 The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.\n\n\n\n21 CFR Part 11.10 (a)\r\n\n21 CFR Part 820.70 (i)\r\n\nA2LA C211 5.4.7.2\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nE.U. Annex 11-11\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 7.11.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 4.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)\r\n\nWHO Technical Report Series, #996, Annex 5, 10.2\n\n\n33.5 The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.\n\n\nASTM E1578-18 S-2-2\r\nCLSI QMS22 2.5\r\nE.U. Annex 11-4\r\nWHO Technical Report Series, #996, Annex 5, 10.3\u20137\n\n33.6 The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.\n\n\n\n34. System administration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 11.200 (a)\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d-5)\r\n\nASTM E1578-18 S-3-1\r\n\nCJIS Security Policy 5.5.5\r\n\nCLSI QMS22 2.4.2\r\n\nNIST 800-53, Rev. 5, AC-11 and AC-12\n\n\n34.1 The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.\n\n\nASTM E1578-18 S-3-2\n\n34.2 The system should provide a means for modifying personnel data in a batch.\n\n\nASTM E1578-18 S-3-3\n\n34.3 The system should support the storage of standard and industry-specific data formats.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.10 (d)\r\n\n21 CFR Part 211.68 (b)\r\n\n42 CFR Part 73.11\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.514\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 S-3-7\r\n\nCJIS Security Policy 5.5.1\r\n\nCJIS Security Policy 5.5.2.4\r\n\nCJIS Security Policy Appendix G.5\r\n\nCLSI QMS22 2.4.2\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nISO 15189:2012 5.10.2\r\n\nNIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\nNIST 800-53, Rev. 5, IA-2 and IA-8\r\n\nNIST 800-53, Rev. 5, MA-4\r\n\nNIST 800-53, Rev. 5, PS-4 and PS-5\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Administrative Procedures for the PDP 5.5.1.2\r\n\nWHO Technical Report Series, #996, Annex 5, 5.4 and Appendix 1\n\n\n34.4 The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.\n\n\nASTM E1578-18 S-3-8\n\n34.5 The vendor should provide maintenance agreements and support services for its applications and services.\n\n\nASTM E1578-18 S-3-9\r\n\nE.U. Annex 11-3.3\r\n\nNIST 800-53, Rev. 5, SA-16\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\n\n\n34.6 The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.10 (c)\r\n\n42 CFR Part 73.11\r\n\n45 CFR Part 164.310\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.4.3\r\n\nABFT Accreditation Manual Sec. D-5\u2013D-8\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\nASTM E1492-11 4.2.4\r\n\nCJIS Security Policy 5.5.2\r\n\nCJIS Security Policy 5.8.1\r\n\nEPA ERLN Laboratory Requirements 4.9.6\r\n\nE.U. Annex 11-7.1\r\n\nE.U. Annex 11-12\r\n\nISO 15189:2012 5.10.2\r\n\nISO\/IEC 17025:2017 7.11.3\r\n\nNIST 800-53, Rev. 5, MA-5\r\n\nNIST 800-53, Rev. 5, MP-2\r\n\nNIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\n\n\n34.7 The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)\n\n\nCJIS Security Policy 5.5.1\n\n34.8 The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n42 CFR Part 73.17\r\n\nASTM E1578-18 S-3-10\n\n\n34.9 The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n42 CFR Part 73.11\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 S-3-11\r\n\nCJIS Security Policy 5.10.4.1\r\n\nCLSI QMS22 2.1.4\r\n\nCLSI QMS22 2.6.1\r\n\nEPA ERLN Laboratory Requirements 4.9.13\r\n\nNIST 800-53, Rev. 5, SI-2(5)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n34.10 The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.\n\n\nASTM E1578-18 S-3-12\n\n34.11 The system shall provide a means for migrating data to a new release upon system upgrade.\n\n\n21 CFR Part 1.1154 (b)\r\nASTM E1578-18 S-3-13\n\n34.12 The system should be expedient with the retrieval of stored items.\n\n\n\n21 CFR Part 11.10 (b)\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nE.U. Annex 11-5\r\n\nE.U. Annex 11-8.1\n\n\n34.13 The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.\n\n\nASTM E1578-18 S-3-14\n\n34.14 The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.\n\n\nASTM E1578-18 S-3-15\r\n\nEPA ERLN Laboratory Requirements 4.9.13\r\n\nNIST 800-53, Rev. 5, CM-3(2)\r\n\nNIST 800-53, Rev. 5, SI-2\n\n\n34.15 The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.\n\n\n\n35. Cybersecurity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n42 CFR Part 493.1231\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d-9)\r\n\nASTM E1578-18 S-4-1\r\n\nCJIS Security Policy 5.6.4\r\n\nCJIS Security Policy 5.8.2.1\r\n\nCJIS Security Policy 5.10.1.2\r\n\nCJIS Security Policy Appendix G.6\r\n\nCLSI QMS22 2.2.3.2\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nNIST 800-53, Rev. 5, AC-17(2)\n\n\n35.1 The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.\n\n\n\n42 CFR Part 493.1231\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d)\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.6\r\n\nASTM E1578-18 S-4-2\r\n\nCJIS Security Policy 5.5.2.4\r\n\nCJIS Security Policy 5.10.1.2\r\n\nCJIS Security Policy Appendix G.6\r\n\nNIST 800-53, Rev. 5, SC-13 and SC-28(1)\n\n\n35.2 The system should support database encryption and be capable of recording the encryption status of the data contained within.\n\n\n42 CFR Part 493.1231\r\n\nCJIS Security Policy 5.6.2.2.1\r\n\nCLSI QMS22 2.4.2.2\r\n\nNIST 800-53, Rev. 5, AC-3\r\n\nNIST 800-53, Rev. 5, IA-2, IA-2(1\u20134), and IA-8\r\n\nNIST 800-53, Rev. 5, MA-4\n\n\n35.3 The system should be able to support multifactor authentication.\n\n\n45 CFR Part 170.202\r\n45 CFR Part 170.315 (h)\n\n35.4 The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information.\n\n\nNIST 800-53, Rev. 5, IA-7\n\n35.5 The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.\n\n\nNIST 800-53, Rev. 5, SC-15\n\n35.6 The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.\n\n\n\n36. Information privacy \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n45 CFR Part 164 Subpart E\r\nACMG Technical Standards for Clinical Genetics Laboratories G17.2\r\nASTM E1578-18 S-5-1\r\nCAP Laboratory Accreditation Manual\n\n36.1 The system shall comply with privacy protection compliance like that found in HIPAA provisions.\n\n\n\n10 CFR Part 20.2106 (d)\r\n\n45 CFR Part 164.105\r\n\n45 CFR Part 164 Subpart C\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 S-5-2\r\n\nICH GCP 2.11\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.3\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\n\n\n36.2 The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.\n\n\n45 CFR Part 164.514\r\nACMG Technical Standards for Clinical Genetics Laboratories C5.5\r\nCAP Laboratory Accreditation Manual\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3\n\n\n36.3 The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.\n\n\n45 CFR Part 164 Subpart E\r\n\nNIST 800-53, Rev. 5, AC-6\n\n\n36.4 The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.\n\n\nNIST 800-53, Rev. 5, SI-19(7)\n\n36.5 The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#34._System_administration\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#34._System_administration<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 20 September 2019, at 18:12.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 1,950 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","4e61932b867065094a0b64f809b55574_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Security_and_Integrity_of_Systems_and_Operations rootpage-LII_LIMSpec_Security_and_Integrity_of_Systems_and_Operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Security and Integrity of Systems and Operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"31._Data_integrity\">31. Data integrity<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 9.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.1<\/b> System functionality should support ALCOA principles.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.2<\/b> The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.305\" target=\"_blank\">42 CFR Part 93.305<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.310\" target=\"_blank\">42 CFR Part 93.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.3<\/b> The system shall securely maintain a true, readable copy of an instrument's original (raw) data for on-demand review.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.30\" target=\"_blank\">7 CFR Part 91.30<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.195\" target=\"_blank\">21 CFR Part 58.195<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (n)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.164<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.180\" target=\"_blank\">21 CFR Part 211.180<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 212.110 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42 (b-8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (c\u2013d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.202\" target=\"_blank\">21 CFR Part 225.202<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.115\" target=\"_blank\">21 CFR Part 226.115<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.208<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.160\" target=\"_blank\">21 CFR Part 606.160 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.180\" target=\"_blank\">21 CFR Part 820.180 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120 (f)(8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.722\" target=\"_blank\">40 CFR Part 141.722<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.11\" target=\"_blank\">40 CFR Part 262.11 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.40\" target=\"_blank\">40 CFR Part 262.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.213\" target=\"_blank\">40 CFR Part 262.213<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\/subpart-A\" target=\"_blank\">40 CFR Part 704 Subpart A<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/717.15\" target=\"_blank\">40 CFR Part 717.15 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.313\" target=\"_blank\">42 CFR Part 93.313 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.317\" target=\"_blank\">42 CFR Part 93.317<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1105\" target=\"_blank\">42 CFR Part 493.1105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.105\" target=\"_blank\">45 CFR Part 164.105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.316\" target=\"_blank\">45 CFR Part 164.316<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories E2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.4<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.18<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 2.1.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 2.1.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-11 and AU-11(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020(d)(1)(i\u2013ii)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(j)(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.8\u20139<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.4<\/b> The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.5<\/b> The system shall accurately reflect the system date and time in its use of electronic record time stamps.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-7<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.6<\/b> The system shall require each and every user to be assigned a unique user ID.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.7<\/b> The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.8<\/b> The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"32._Configuration_management\">32. Configuration management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.1<\/b> The system shall provide tools to enter and manage user-configurable lookup or master data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.2<\/b> The system shall allow authorized users to configure the specification limits for sample and instrument tests.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/162.1002\" target=\"_blank\">45 CFR Part 162.1002<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.3.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.3<\/b> The system shall allow system nomenclature to be configured to use specific data code sets\u2014such as the International Classification of Diseases or the Healthcare Common Procedure Coding System\u2014or mandated terminology to support regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.4<\/b> The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.5<\/b> The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.6<\/b> The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.10\" target=\"_blank\">40 CFR Part 3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.2000\" target=\"_blank\">40 CFR Part 3.2000<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C13.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.7<\/b> The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.8<\/b> The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.9<\/b> The system shall support configurable laboratory workflows based on appropriate laboratory process and procedure.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.10<\/b> The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of laboratory workflow.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.11<\/b> The system should allow authorized personnel to perform revision control of lookup or master data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-10<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.12<\/b> The system should provide a means for importing lookup or master data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 9.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.13<\/b> The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.14<\/b> The system should allow calculated limits to be created and managed based on test results and relevant metadata.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-13<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.15<\/b> The system should provide a clear alert or notification upon entry of out-of-specification results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.16<\/b> The system shall allow authorized personnel to update static and dynamic data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-15<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.17<\/b> The system should allow workflow events and status changes to trigger one or more user-defined actions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-17<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.18<\/b> The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-18<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.19<\/b> The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-19<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.20<\/b> The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.21<\/b> The system should support rules governing electronic records and electronic signatures in regulated environments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2110\" target=\"_blank\">10 CFR Part 20.2110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51 (c-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4 and 4.9.14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5 and CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.22<\/b> The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(11)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.23<\/b> The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-22<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2(10)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.24<\/b> The system should support single sign-on such that a user can log in once and access all permitted functions and data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(7) and AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.25<\/b> The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-4 and IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.26<\/b> The system shall prevent the same combination of identification components from being used across more than one account.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5 and IA-5(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.27<\/b> The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(3)<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-4 and IA-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PS-4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.28<\/b> The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.29<\/b> The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.30<\/b> The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.31<\/b> The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.32<\/b> The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.33<\/b> The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188 (b-11)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (a-7 and a-8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (c-10)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.34<\/b> The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.35<\/b> The system shall support the ability to initially assign new individual users to system groups, roles, or both.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.36<\/b> The system shall force a user's electronic signature to be unique and traceable to a specific user's account.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>32.37<\/b> The system shall prevent the reuse or reassignment of a user's electronic signature.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.50\" target=\"_blank\">21 CFR Part 11.50<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.38<\/b> When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-26<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.39<\/b> The system should provide a means to migrate static data into the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5(1)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.40<\/b> The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.41<\/b> The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"33._System_validation_and_commission\">33. System validation and commission<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.1<\/b> The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(2)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.2<\/b> The vendor should be willing to provide access to source code through a suitable escrow.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.3<\/b> The system should be able to document a summary and evaluation of enterprise performance markers and processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>33.4<\/b> The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>33.5<\/b> The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.3\u20137<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.6<\/b> The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"34._System_administration\">34. System administration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-11 and AC-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.1<\/b> The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.2<\/b> The system should provide a means for modifying personnel data in a batch.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.3<\/b> The system should support the storage of standard and industry-specific data formats.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(7) and AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2 and IA-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PS-4 and PS-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 5.4 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.4<\/b> The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.5<\/b> The vendor should provide maintenance agreements and support services for its applications and services.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-9<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.6<\/b> The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D-5\u2013D-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MP-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.7<\/b> The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.8<\/b> The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.9<\/b> The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2(5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.10<\/b> The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.11<\/b> The system shall provide a means for migrating data to a new release upon system upgrade.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-13<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.12<\/b> The system should be expedient with the retrieval of stored items.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.13<\/b> The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.14<\/b> The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-15<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-3(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.15<\/b> The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"35._Cybersecurity\">35. Cybersecurity<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-9)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-4-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.8.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>35.1<\/b> The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-4-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-13 and SC-28(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>35.2<\/b> The system should support database encryption and be capable of recording the encryption status of the data contained within.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-2(1\u20134), and IA-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>35.3<\/b> The system should be able to support multifactor authentication.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.202\" target=\"_blank\">45 CFR Part 170.202<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (h)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>35.4<\/b> The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>35.5<\/b> The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-15<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>35.6<\/b> The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"36._Information_privacy\">36. Information privacy<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-E\" target=\"_blank\">45 CFR Part 164 Subpart E<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G17.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-5-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.1<\/b> The system shall comply with privacy protection compliance like that found in HIPAA provisions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2106\" target=\"_blank\">10 CFR Part 20.2106 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.105\" target=\"_blank\">45 CFR Part 164.105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-C\" target=\"_blank\">45 CFR Part 164 Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-5-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 2.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>36.2<\/b> The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>36.3<\/b> The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-E\" target=\"_blank\">45 CFR Part 164 Subpart E<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>36.4<\/b> The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-19(7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.5<\/b> The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173546\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.060 seconds\nReal time usage: 0.064 seconds\nPreprocessor visited node count: 478\/1000000\nPost\u2010expand include size: 78225\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 13.410 1 -total\n 20.15% 2.702 1 Template:LIMSpec\/Configuration_management\n 15.95% 2.139 1 Template:LIMSpec\/System_validation_and_commission\n 15.72% 2.108 1 Template:LIMSpec\/Data_integrity\n 14.72% 1.974 1 Template:LIMSpec\/System_administration\n 13.47% 1.807 1 Template:LIMSpec\/Information_privacy\n 13.26% 1.778 1 Template:LIMSpec\/Cybersecurity\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11215-0!canonical and timestamp 20221202173546 and revision id 36393. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#34._System_administration\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#34._System_administration<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","4e61932b867065094a0b64f809b55574_images":[],"4e61932b867065094a0b64f809b55574_timestamp":1670002547,"962b522f454655e6db263e82dc72efff_type":"article","962b522f454655e6db263e82dc72efff_title":"33. System validation and commission","962b522f454655e6db263e82dc72efff_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#33._System_validation_and_commission","962b522f454655e6db263e82dc72efff_plaintext":"\n\nLII:LIMSpec\/Security and Integrity of Systems and OperationsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.\n\n31. Data integrity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-17-1\r\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\nWHO Technical Report Series, #996, Annex 5, 9.1\n\n31.1 System functionality should support ALCOA principles.\n\n\n\n61 FR 38806, 9 CFR Part 417.5\r\n\nASTM E1578-18 E-17-2\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nA2LA C211 4.13.2.3\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nNIST 800-53, Rev. 5, SI-12\n\n\n31.2 The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.\n\n\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 58.190\r\n\n42 CFR Part 93.305\r\n\n42 CFR Part 93.310\r\n\nASTM E1578-18 E-17-3\r\n\nCLSI QMS22 2.2.2.2\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\r\n\nNIST 800-53, Rev. 5, SI-12\r\n\nOECD GLP Principles 10\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\r\n\nUSDA Data and Instrumentation for PDP 8.1.3\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n\n31.3 The system shall securely maintain a true, readable copy of an instrument's original (raw) data for on-demand review.\n\n\n\n7 CFR Part 91.30\r\n\n7 CFR Part 331.17 (c)\r\n\n9 CFR Part 2.35\r\n\n9 CFR Part 121.17 (c)\r\n\n10 CFR Part 20.2103\u201310\r\n\n10 CFR Part 30.34 (g)\r\n\n10 CFR Part 30.51\u20132\r\n\n21 CFR Part 1.1154 (a)\r\n\n21 CFR Part 11.10 (c)\r\n\n21 CFR Part 58.195\r\n\n21 CFR Part 106.100 (n)\r\n\n21 CFR Part 112.164\r\n\n21 CFR Part 114.100 (e)\r\n\n21 CFR Part 117.315\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.9\r\n\n21 CFR Part 129.80 (h)\r\n\n21 CFR Part 211.180\r\n\n21 CFR Part 212.110 (c)\r\n\n21 CFR Part 225.42 (b-8)\r\n\n21 CFR Part 225.58 (c\u2013d)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 225.110\r\n\n21 CFR Part 225.158\r\n\n21 CFR Part 225.202\r\n\n21 CFR Part 226.42 (a)\r\n\n21 CFR Part 226.58 (f)\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 226.115\r\n\n21 CFR Part 312.57\r\n\n21 CFR Part 312.62\r\n\n21 CFR Part 507.208\r\n\n21 CFR Part 606.160 (d)\r\n\n21 CFR Part 812.140 (d)\r\n\n21 CFR Part 820.180 (b)\r\n\n29 CFR Part 1910.120 (f)(8)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n40 CFR Part 141.33\r\n\n40 CFR Part 141.722\r\n\n40 CFR Part 262.11 (f)\r\n\n40 CFR Part 262.40\r\n\n40 CFR Part 262.213\r\n\n40 CFR Part 704 Subpart A\r\n\n40 CFR Part 717.15 (d)\r\n\n42 CFR Part 73.17 (c)\r\n\n42 CFR Part 93.313 (h)\r\n\n42 CFR Part 93.317\r\n\n42 CFR Part 493.1105\r\n\n42 CFR Part 493.1283\r\n\n45 CFR Part 164.105\r\n\n45 CFR Part 164.316\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\n61 FR 38806, 9 CFR Part 417.5\r\n\nA2LA C223 5.4\r\n\nA2LA C223 5.9\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.1.2\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.2.1\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.3.2\r\n\nABFT Accreditation Manual Sec. E-33\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.6\r\n\nACMG Technical Standards for Clinical Genetics Laboratories E2.1\r\n\nAIHA-LAP Policies 2022 2A.7.5.1\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7\r\n\nASTM E1578-18 E-17-4\r\n\nBRC GSFS, Issue 8, 3.3.2\r\n\nCAP Laboratory Accreditation Manual\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.3.4\r\n\nCJIS Security Policy 5.4.6\u20137\r\n\nCJIS Security Policy 5.5.2.1\r\n\nCLSI QMS22 2.8.3\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.4\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nE.U. Annex 11-7.1\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.1\r\n\nE.U. Commission Directive 2003\/94\/EC Article 11.4\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c\r\n\nEPA 815-R-05-004 Chap. III, Sec. 15\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nEPA ERLN Laboratory Requirements 4.9.18\r\n\nEPA ERLN Laboratory Requirements 4.11.17\r\n\nEPA QA\/G-5 2.1.9\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3\r\n\nICH GCP 4.9.5\r\n\nIFS Food 7, Part 2, 2.1.2.2\r\n\nIFS PACsecure 2, Part 2, 2.1.2.2\r\n\nISO 15189:2012 4.3\r\n\nISO\/IEC 17025:2017 8.4.2\r\n\nNIST 800-53, Rev. 5, AT-4\r\n\nNIST 800-53, Rev. 5, AU-11 and AU-11(1)\r\n\nNIST 800-53, Rev. 5, SI-12\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 10\r\n\nOSHA 1910.1020(d)(1)(i\u2013ii)\r\n\nOSHA 1910.1450(j)(2)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.2.3.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP 5.4\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c\r\n\nUSDA Sampling Procedures for PDP 6.5\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0\r\n\nWHO Technical Report Series, #986, Annex 2, 15.8\u20139\r\n\nWHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1\n\n\n31.4 The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.\n\n\nASTM E1578-18 E-17-6\r\nCJIS Security Policy 5.4.4\r\nNIST 800-53, Rev. 5, AU-8\r\nWHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n31.5 The system shall accurately reflect the system date and time in its use of electronic record time stamps.\n\n\nAPHL 2019 LIS Project Management Guidebook\r\nASTM E1578-18 E-17-7\r\nCJIS Security Policy 5.6.1\n\n31.6 The system shall require each and every user to be assigned a unique user ID.\n\n\n\nASTM E1578-18 E-17-8\r\n\n21 CFR Part 11.10 (e)\r\n\nCJIS Security Policy 5.4.5\r\n\nE.U. Annex 11-9\r\n\nNIST 800-53, Rev. 5, AU-9\n\n\n31.7 The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.\n\n\nCJIS Security Policy 5.4.2\r\nNIST 800-53, Rev. 5, AU-5\r\nNIST 800-53, Rev. 5, SI-4\n\n31.8 The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.\n\n\n\n32. Configuration management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 S-1-1\r\nAPHL 2019 LIS Project Management Guidebook\n\n32.1 The system shall provide tools to enter and manage user-configurable lookup or master data.\n\n\nASTM E1578-18 S-1-2\n\n32.2 The system shall allow authorized users to configure the specification limits for sample and instrument tests.\n\n\n45 CFR Part 162.1002\r\nUSDA Sampling Procedures for PDP 6.3.2\n\n32.3 The system shall allow system nomenclature to be configured to use specific data code sets\u2014such as the International Classification of Diseases or the Healthcare Common Procedure Coding System\u2014or mandated terminology to support regulatory requirements.\n\n\nASTM E1578-18 S-1-3\n\n32.4 The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.\n\n\nASTM E1578-18 S-1-4\n\n32.5 The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.\n\n\n21 CFR Part 211.100 (b)\r\n21 CFR Part 211.160 (a)\n\n32.6 The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.\n\n\n\n40 CFR Part 3.10\r\n\n40 CFR Part 3.2000\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C13.3\r\n\nASTM E1578-18 S-1-5\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.7 The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.\n\n\nASTM E1578-18 S-1-6\n\n32.8 The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.\n\n\nASTM E1578-18 S-1-7\n\n32.9 The system shall support configurable laboratory workflows based on appropriate laboratory process and procedure.\n\n\nASTM E1578-18 S-1-8\n\n32.10 The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of laboratory workflow.\n\n\n21 CFR Part 211.68\r\nAPHL 2019 LIS Project Management Guidebook\r\nASTM E1578-18 S-1-9\n\n32.11 The system should allow authorized personnel to perform revision control of lookup or master data.\n\n\nASTM E1578-18 S-1-10\r\nAPHL 2019 LIS Project Management Guidebook\n\n32.12 The system should provide a means for importing lookup or master data.\n\n\n\nAIHA-LAP Policies 2022 2A.7.8.4\r\n\nASTM E1578-18 S-1-11\r\n\nEPA ERLN Laboratory Requirements 4.11.6\r\n\nUSDA Data and Instrumentation for PDP 9.1\n\n\n32.13 The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.\n\n\nASTM E1578-18 S-1-12\n\n32.14 The system should allow calculated limits to be created and managed based on test results and relevant metadata.\n\n\nASTM E1578-18 S-1-13\r\nEPA ERLN Laboratory Requirements 3.2.6\r\nEPA ERLN Laboratory Requirements 4.9.11\n\n32.15 The system should provide a clear alert or notification upon entry of out-of-specification results.\n\n\nASTM E1578-18 S-1-14\n\n32.16 The system shall allow authorized personnel to update static and dynamic data.\n\n\nASTM E1578-18 S-1-15\n\n32.17 The system should allow workflow events and status changes to trigger one or more user-defined actions.\n\n\nASTM E1578-18 S-1-17\r\n\nCJIS Security Policy 5.7.1\r\n\nNIST 800-53, Rev. 5, AC-6(1)\r\n\nNIST 800-53, Rev. 5, CM-7\n\n\n32.18 The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.\n\n\nASTM E1578-18 S-1-18\r\nCAP Laboratory Accreditation Manual\n\n32.19 The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.\n\n\nASTM E1578-18 S-1-19\n\n32.20 The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.\n\n\n21 CFR Part 11.100 (a)\r\n\nASTM E1578-18 S-1-20\r\n\nE.U. Annex 11-14\r\n\nNIST 800-53, Rev. 5, CM-5(1)\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.21 The system should support rules governing electronic records and electronic signatures in regulated environments.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n10 CFR Part 20.2110\r\n\n10 CFR Part 30.51 (c-1\r\n\n21 CFR Part 11.10 (d)\r\n\n21 CFR Part 211.68\r\n\n42 CFR Part 73.11\r\n\n45 CFR Part 164.308\r\n\nA2LA C211 4.13.1.4\r\n\nA2LA C211 5.4.7.2\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.4.1\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\nASTM E1492-11 4.2.4\r\n\nASTM E1578-18 S-1-16\r\n\nASTM E1578-18 S-1-21\r\n\nCJIS Security Policy 5.5.2\r\n\nCLSI QMS22 2.4.3\r\n\nE.U. Annex 11-12\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nEPA ERLN Laboratory Requirements 4.9.4 and 4.9.14\r\n\nICH GCP 2.10\r\n\nISO\/IEC 17025:2017 7.11.3\r\n\nNIST 800-53, Rev. 5, CM-5 and CM-5(1)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\n\n\n32.22 The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.\n\n\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nCJIS Security Policy 5.5.2.2\u20133\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nNIST 800-53, Rev. 5, AC-2(11)\n\n\n32.23 The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.\n\n\nASTM E1578-18 S-1-22\r\nNIST 800-53, Rev. 5, IA-2(10)\n\n32.24 The system should support single sign-on such that a user can log in once and access all permitted functions and data.\n\n\n\n21 CFR Part 11.200 (a)\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d)\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCJIS Security Policy 5.6.1\r\n\nCLSI QMS22 2.4.2.2\r\n\nE.U. Annex 11-14\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nEPA ERLN Laboratory Requirements 4.9.4\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\nNIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\r\n\nNIST 800-53, Rev. 5, MA-4\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.25 The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.\n\n\n\n21 CFR Part 11.300 (a)\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, IA-4 and IA-5\n\n\n32.26 The system shall prevent the same combination of identification components from being used across more than one account.\n\n\n\n21 CFR Part 11.300 (b)\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCLSI QMS22 2.4.2\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, IA-5 and IA-5(1)\n\n\n32.27 The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.\n\n\nCJIS Security Policy 5.6.3.1\r\nNIST 800-53, Rev. 5, AC-2(3)\r\n\nNIST 800-53, Rev. 5, IA-4 and IA-5(1)\r\n\nNIST 800-53, Rev. 5, PS-4\n\n\n32.28 The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.\n\n\nCJIS Security Policy 5.5.2.2\r\nNIST 800-53, Rev. 5, AC-10\n\n32.29 The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.\n\n\nCJIS Security Policy 5.5.4\r\nNIST 800-53, Rev. 5, AC-8\n\n32.30 The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.\n\n\n\n21 CFR Part 11.300 (d)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\nA2LA C211 4.13.2.1\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCLSI QMS22 2.4.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, CM-5(1)\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\n\n\n32.31 The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.\n\n\n\n21 CFR Part 11.300 (d)\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCJIS Security Policy 5.5.3\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, AC-7\n\n\n32.32 The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.\n\n\n21 CFR Part 11.200 (a)\r\nASTM E1578-18 S-3-1\n\n32.33 The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.200 (a)\r\n\n21 CFR Part 211.68 (b)\r\n\n21 CFR Part 211.188 (b-11)\r\n\n21 CFR Part 211.194 (a-7 and a-8)\r\n\n21 CFR Part 212.50 (c-10)\r\n\n42 CFR Part 73.11\r\n\nASTM E1578-18 S-3-1\r\n\nCJIS Security Policy 5.6.3.2\r\n\nNIST 800-53, Rev. 5, IA-5\n\n\n32.34 The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.10 (d)\r\n\n42 CFR Part 73.11\r\n\n42 CFR Part 493.1231\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.514\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 S-1-25\r\n\nCJIS Security Policy 5.5.1\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nNIST 800-53, Rev. 5, AC-3\r\n\nNIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\n\n\n32.35 The system shall support the ability to initially assign new individual users to system groups, roles, or both.\n\n\n\n21 CFR Part 11.100 (a)\r\n\n45 CFR Part 164.312\r\n\nASTM E1578-18 S-1-24\r\n\nE.U. Annex 11-14\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.36 The system shall force a user's electronic signature to be unique and traceable to a specific user's account.\n\n\n21 CFR Part 11.100 (a)\r\nASTM E1578-18 S-1-24\r\n\n\n32.37 The system shall prevent the reuse or reassignment of a user's electronic signature.\n\n\n21 CFR Part 11.50\r\nE.U. Annex 11-14\n\n32.38 When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.\n\n\n\nASTM E1578-18 S-1-26\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nCLSI QMS22 2.8.5.3\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.39 The system should provide a means to migrate static data into the system.\n\n\nNIST 800-53, Rev. 5, IA-5(1)\r\nCLSI QMS22 2.4.2\n\n32.40 The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.\n\n\nNIST 800-53, Rev. 5, IA-6\n\n32.41 The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.\n\n\n\n33. System validation and commission \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 S-2-1\r\nCJIS Security Policy Appendix G.8\r\nNIST 800-53, Rev. 5, SA-4(3)\n\n33.1 The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.\n\n\nASTM E1578-18 S-2-2\r\nNIST 800-53, Rev. 5, SA-4(2)\n\n33.2 The vendor should be willing to provide access to source code through a suitable escrow.\n\n\nASTM E1578-18 S-2-3\n\n33.3 The system should be able to document a summary and evaluation of enterprise performance markers and processes.\n\n\n\nA2LA C211 5.4.7.2\r\n\nASTM E1578-18 S-2-4\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 7.11.5\r\n\nNIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5\n\n\n33.4 The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.\n\n\n\n21 CFR Part 11.10 (a)\r\n\n21 CFR Part 820.70 (i)\r\n\nA2LA C211 5.4.7.2\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nE.U. Annex 11-11\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 7.11.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 4.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)\r\n\nWHO Technical Report Series, #996, Annex 5, 10.2\n\n\n33.5 The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.\n\n\nASTM E1578-18 S-2-2\r\nCLSI QMS22 2.5\r\nE.U. Annex 11-4\r\nWHO Technical Report Series, #996, Annex 5, 10.3\u20137\n\n33.6 The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.\n\n\n\n34. System administration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 11.200 (a)\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d-5)\r\n\nASTM E1578-18 S-3-1\r\n\nCJIS Security Policy 5.5.5\r\n\nCLSI QMS22 2.4.2\r\n\nNIST 800-53, Rev. 5, AC-11 and AC-12\n\n\n34.1 The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.\n\n\nASTM E1578-18 S-3-2\n\n34.2 The system should provide a means for modifying personnel data in a batch.\n\n\nASTM E1578-18 S-3-3\n\n34.3 The system should support the storage of standard and industry-specific data formats.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.10 (d)\r\n\n21 CFR Part 211.68 (b)\r\n\n42 CFR Part 73.11\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.514\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 S-3-7\r\n\nCJIS Security Policy 5.5.1\r\n\nCJIS Security Policy 5.5.2.4\r\n\nCJIS Security Policy Appendix G.5\r\n\nCLSI QMS22 2.4.2\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nISO 15189:2012 5.10.2\r\n\nNIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\nNIST 800-53, Rev. 5, IA-2 and IA-8\r\n\nNIST 800-53, Rev. 5, MA-4\r\n\nNIST 800-53, Rev. 5, PS-4 and PS-5\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Administrative Procedures for the PDP 5.5.1.2\r\n\nWHO Technical Report Series, #996, Annex 5, 5.4 and Appendix 1\n\n\n34.4 The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.\n\n\nASTM E1578-18 S-3-8\n\n34.5 The vendor should provide maintenance agreements and support services for its applications and services.\n\n\nASTM E1578-18 S-3-9\r\n\nE.U. Annex 11-3.3\r\n\nNIST 800-53, Rev. 5, SA-16\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\n\n\n34.6 The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.10 (c)\r\n\n42 CFR Part 73.11\r\n\n45 CFR Part 164.310\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.4.3\r\n\nABFT Accreditation Manual Sec. D-5\u2013D-8\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\nASTM E1492-11 4.2.4\r\n\nCJIS Security Policy 5.5.2\r\n\nCJIS Security Policy 5.8.1\r\n\nEPA ERLN Laboratory Requirements 4.9.6\r\n\nE.U. Annex 11-7.1\r\n\nE.U. Annex 11-12\r\n\nISO 15189:2012 5.10.2\r\n\nISO\/IEC 17025:2017 7.11.3\r\n\nNIST 800-53, Rev. 5, MA-5\r\n\nNIST 800-53, Rev. 5, MP-2\r\n\nNIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\n\n\n34.7 The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)\n\n\nCJIS Security Policy 5.5.1\n\n34.8 The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n42 CFR Part 73.17\r\n\nASTM E1578-18 S-3-10\n\n\n34.9 The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n42 CFR Part 73.11\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 S-3-11\r\n\nCJIS Security Policy 5.10.4.1\r\n\nCLSI QMS22 2.1.4\r\n\nCLSI QMS22 2.6.1\r\n\nEPA ERLN Laboratory Requirements 4.9.13\r\n\nNIST 800-53, Rev. 5, SI-2(5)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n34.10 The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.\n\n\nASTM E1578-18 S-3-12\n\n34.11 The system shall provide a means for migrating data to a new release upon system upgrade.\n\n\n21 CFR Part 1.1154 (b)\r\nASTM E1578-18 S-3-13\n\n34.12 The system should be expedient with the retrieval of stored items.\n\n\n\n21 CFR Part 11.10 (b)\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nE.U. Annex 11-5\r\n\nE.U. Annex 11-8.1\n\n\n34.13 The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.\n\n\nASTM E1578-18 S-3-14\n\n34.14 The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.\n\n\nASTM E1578-18 S-3-15\r\n\nEPA ERLN Laboratory Requirements 4.9.13\r\n\nNIST 800-53, Rev. 5, CM-3(2)\r\n\nNIST 800-53, Rev. 5, SI-2\n\n\n34.15 The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.\n\n\n\n35. Cybersecurity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n42 CFR Part 493.1231\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d-9)\r\n\nASTM E1578-18 S-4-1\r\n\nCJIS Security Policy 5.6.4\r\n\nCJIS Security Policy 5.8.2.1\r\n\nCJIS Security Policy 5.10.1.2\r\n\nCJIS Security Policy Appendix G.6\r\n\nCLSI QMS22 2.2.3.2\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nNIST 800-53, Rev. 5, AC-17(2)\n\n\n35.1 The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.\n\n\n\n42 CFR Part 493.1231\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d)\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.6\r\n\nASTM E1578-18 S-4-2\r\n\nCJIS Security Policy 5.5.2.4\r\n\nCJIS Security Policy 5.10.1.2\r\n\nCJIS Security Policy Appendix G.6\r\n\nNIST 800-53, Rev. 5, SC-13 and SC-28(1)\n\n\n35.2 The system should support database encryption and be capable of recording the encryption status of the data contained within.\n\n\n42 CFR Part 493.1231\r\n\nCJIS Security Policy 5.6.2.2.1\r\n\nCLSI QMS22 2.4.2.2\r\n\nNIST 800-53, Rev. 5, AC-3\r\n\nNIST 800-53, Rev. 5, IA-2, IA-2(1\u20134), and IA-8\r\n\nNIST 800-53, Rev. 5, MA-4\n\n\n35.3 The system should be able to support multifactor authentication.\n\n\n45 CFR Part 170.202\r\n45 CFR Part 170.315 (h)\n\n35.4 The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information.\n\n\nNIST 800-53, Rev. 5, IA-7\n\n35.5 The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.\n\n\nNIST 800-53, Rev. 5, SC-15\n\n35.6 The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.\n\n\n\n36. Information privacy \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n45 CFR Part 164 Subpart E\r\nACMG Technical Standards for Clinical Genetics Laboratories G17.2\r\nASTM E1578-18 S-5-1\r\nCAP Laboratory Accreditation Manual\n\n36.1 The system shall comply with privacy protection compliance like that found in HIPAA provisions.\n\n\n\n10 CFR Part 20.2106 (d)\r\n\n45 CFR Part 164.105\r\n\n45 CFR Part 164 Subpart C\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 S-5-2\r\n\nICH GCP 2.11\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.3\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\n\n\n36.2 The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.\n\n\n45 CFR Part 164.514\r\nACMG Technical Standards for Clinical Genetics Laboratories C5.5\r\nCAP Laboratory Accreditation Manual\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3\n\n\n36.3 The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.\n\n\n45 CFR Part 164 Subpart E\r\n\nNIST 800-53, Rev. 5, AC-6\n\n\n36.4 The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.\n\n\nNIST 800-53, Rev. 5, SI-19(7)\n\n36.5 The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#33._System_validation_and_commission\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#33._System_validation_and_commission<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 20 September 2019, at 18:12.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 1,950 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","962b522f454655e6db263e82dc72efff_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Security_and_Integrity_of_Systems_and_Operations rootpage-LII_LIMSpec_Security_and_Integrity_of_Systems_and_Operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Security and Integrity of Systems and Operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"31._Data_integrity\">31. Data integrity<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 9.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.1<\/b> System functionality should support ALCOA principles.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.2<\/b> The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.305\" target=\"_blank\">42 CFR Part 93.305<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.310\" target=\"_blank\">42 CFR Part 93.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.3<\/b> The system shall securely maintain a true, readable copy of an instrument's original (raw) data for on-demand review.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.30\" target=\"_blank\">7 CFR Part 91.30<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.195\" target=\"_blank\">21 CFR Part 58.195<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (n)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.164<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.180\" target=\"_blank\">21 CFR Part 211.180<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 212.110 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42 (b-8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (c\u2013d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.202\" target=\"_blank\">21 CFR Part 225.202<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.115\" target=\"_blank\">21 CFR Part 226.115<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.208<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.160\" target=\"_blank\">21 CFR Part 606.160 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.180\" target=\"_blank\">21 CFR Part 820.180 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120 (f)(8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.722\" target=\"_blank\">40 CFR Part 141.722<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.11\" target=\"_blank\">40 CFR Part 262.11 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.40\" target=\"_blank\">40 CFR Part 262.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.213\" target=\"_blank\">40 CFR Part 262.213<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\/subpart-A\" target=\"_blank\">40 CFR Part 704 Subpart A<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/717.15\" target=\"_blank\">40 CFR Part 717.15 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.313\" target=\"_blank\">42 CFR Part 93.313 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.317\" target=\"_blank\">42 CFR Part 93.317<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1105\" target=\"_blank\">42 CFR Part 493.1105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.105\" target=\"_blank\">45 CFR Part 164.105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.316\" target=\"_blank\">45 CFR Part 164.316<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories E2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.4<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.18<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 2.1.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 2.1.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-11 and AU-11(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020(d)(1)(i\u2013ii)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(j)(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.8\u20139<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.4<\/b> The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.5<\/b> The system shall accurately reflect the system date and time in its use of electronic record time stamps.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-7<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.6<\/b> The system shall require each and every user to be assigned a unique user ID.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.7<\/b> The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.8<\/b> The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"32._Configuration_management\">32. Configuration management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.1<\/b> The system shall provide tools to enter and manage user-configurable lookup or master data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.2<\/b> The system shall allow authorized users to configure the specification limits for sample and instrument tests.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/162.1002\" target=\"_blank\">45 CFR Part 162.1002<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.3.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.3<\/b> The system shall allow system nomenclature to be configured to use specific data code sets\u2014such as the International Classification of Diseases or the Healthcare Common Procedure Coding System\u2014or mandated terminology to support regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.4<\/b> The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.5<\/b> The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.6<\/b> The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.10\" target=\"_blank\">40 CFR Part 3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.2000\" target=\"_blank\">40 CFR Part 3.2000<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C13.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.7<\/b> The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.8<\/b> The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.9<\/b> The system shall support configurable laboratory workflows based on appropriate laboratory process and procedure.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.10<\/b> The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of laboratory workflow.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.11<\/b> The system should allow authorized personnel to perform revision control of lookup or master data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-10<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.12<\/b> The system should provide a means for importing lookup or master data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 9.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.13<\/b> The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.14<\/b> The system should allow calculated limits to be created and managed based on test results and relevant metadata.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-13<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.15<\/b> The system should provide a clear alert or notification upon entry of out-of-specification results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.16<\/b> The system shall allow authorized personnel to update static and dynamic data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-15<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.17<\/b> The system should allow workflow events and status changes to trigger one or more user-defined actions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-17<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.18<\/b> The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-18<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.19<\/b> The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-19<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.20<\/b> The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.21<\/b> The system should support rules governing electronic records and electronic signatures in regulated environments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2110\" target=\"_blank\">10 CFR Part 20.2110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51 (c-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4 and 4.9.14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5 and CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.22<\/b> The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(11)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.23<\/b> The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-22<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2(10)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.24<\/b> The system should support single sign-on such that a user can log in once and access all permitted functions and data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(7) and AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.25<\/b> The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-4 and IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.26<\/b> The system shall prevent the same combination of identification components from being used across more than one account.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5 and IA-5(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.27<\/b> The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(3)<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-4 and IA-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PS-4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.28<\/b> The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.29<\/b> The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.30<\/b> The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.31<\/b> The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.32<\/b> The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.33<\/b> The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188 (b-11)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (a-7 and a-8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (c-10)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.34<\/b> The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.35<\/b> The system shall support the ability to initially assign new individual users to system groups, roles, or both.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.36<\/b> The system shall force a user's electronic signature to be unique and traceable to a specific user's account.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>32.37<\/b> The system shall prevent the reuse or reassignment of a user's electronic signature.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.50\" target=\"_blank\">21 CFR Part 11.50<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.38<\/b> When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-26<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.39<\/b> The system should provide a means to migrate static data into the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5(1)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.40<\/b> The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.41<\/b> The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"33._System_validation_and_commission\">33. System validation and commission<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.1<\/b> The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(2)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.2<\/b> The vendor should be willing to provide access to source code through a suitable escrow.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.3<\/b> The system should be able to document a summary and evaluation of enterprise performance markers and processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>33.4<\/b> The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>33.5<\/b> The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.3\u20137<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.6<\/b> The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"34._System_administration\">34. System administration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-11 and AC-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.1<\/b> The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.2<\/b> The system should provide a means for modifying personnel data in a batch.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.3<\/b> The system should support the storage of standard and industry-specific data formats.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(7) and AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2 and IA-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PS-4 and PS-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 5.4 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.4<\/b> The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.5<\/b> The vendor should provide maintenance agreements and support services for its applications and services.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-9<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.6<\/b> The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D-5\u2013D-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MP-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.7<\/b> The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.8<\/b> The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.9<\/b> The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2(5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.10<\/b> The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.11<\/b> The system shall provide a means for migrating data to a new release upon system upgrade.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-13<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.12<\/b> The system should be expedient with the retrieval of stored items.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.13<\/b> The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.14<\/b> The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-15<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-3(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.15<\/b> The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"35._Cybersecurity\">35. Cybersecurity<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-9)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-4-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.8.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>35.1<\/b> The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-4-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-13 and SC-28(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>35.2<\/b> The system should support database encryption and be capable of recording the encryption status of the data contained within.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-2(1\u20134), and IA-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>35.3<\/b> The system should be able to support multifactor authentication.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.202\" target=\"_blank\">45 CFR Part 170.202<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (h)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>35.4<\/b> The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>35.5<\/b> The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-15<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>35.6<\/b> The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"36._Information_privacy\">36. Information privacy<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-E\" target=\"_blank\">45 CFR Part 164 Subpart E<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G17.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-5-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.1<\/b> The system shall comply with privacy protection compliance like that found in HIPAA provisions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2106\" target=\"_blank\">10 CFR Part 20.2106 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.105\" target=\"_blank\">45 CFR Part 164.105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-C\" target=\"_blank\">45 CFR Part 164 Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-5-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 2.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>36.2<\/b> The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>36.3<\/b> The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-E\" target=\"_blank\">45 CFR Part 164 Subpart E<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>36.4<\/b> The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-19(7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.5<\/b> The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173546\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.060 seconds\nReal time usage: 0.064 seconds\nPreprocessor visited node count: 478\/1000000\nPost\u2010expand include size: 78225\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 13.410 1 -total\n 20.15% 2.702 1 Template:LIMSpec\/Configuration_management\n 15.95% 2.139 1 Template:LIMSpec\/System_validation_and_commission\n 15.72% 2.108 1 Template:LIMSpec\/Data_integrity\n 14.72% 1.974 1 Template:LIMSpec\/System_administration\n 13.47% 1.807 1 Template:LIMSpec\/Information_privacy\n 13.26% 1.778 1 Template:LIMSpec\/Cybersecurity\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11215-0!canonical and timestamp 20221202173546 and revision id 36393. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#33._System_validation_and_commission\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#33._System_validation_and_commission<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","962b522f454655e6db263e82dc72efff_images":[],"962b522f454655e6db263e82dc72efff_timestamp":1670002547,"e972c3ebbff256d2241b0ba5e3831389_type":"article","e972c3ebbff256d2241b0ba5e3831389_title":"32. Configuration management","e972c3ebbff256d2241b0ba5e3831389_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#32._Configuration_management","e972c3ebbff256d2241b0ba5e3831389_plaintext":"\n\nLII:LIMSpec\/Security and Integrity of Systems and OperationsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.\n\n31. Data integrity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-17-1\r\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\nWHO Technical Report Series, #996, Annex 5, 9.1\n\n31.1 System functionality should support ALCOA principles.\n\n\n\n61 FR 38806, 9 CFR Part 417.5\r\n\nASTM E1578-18 E-17-2\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nA2LA C211 4.13.2.3\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nNIST 800-53, Rev. 5, SI-12\n\n\n31.2 The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.\n\n\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 58.190\r\n\n42 CFR Part 93.305\r\n\n42 CFR Part 93.310\r\n\nASTM E1578-18 E-17-3\r\n\nCLSI QMS22 2.2.2.2\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\r\n\nNIST 800-53, Rev. 5, SI-12\r\n\nOECD GLP Principles 10\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\r\n\nUSDA Data and Instrumentation for PDP 8.1.3\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n\n31.3 The system shall securely maintain a true, readable copy of an instrument's original (raw) data for on-demand review.\n\n\n\n7 CFR Part 91.30\r\n\n7 CFR Part 331.17 (c)\r\n\n9 CFR Part 2.35\r\n\n9 CFR Part 121.17 (c)\r\n\n10 CFR Part 20.2103\u201310\r\n\n10 CFR Part 30.34 (g)\r\n\n10 CFR Part 30.51\u20132\r\n\n21 CFR Part 1.1154 (a)\r\n\n21 CFR Part 11.10 (c)\r\n\n21 CFR Part 58.195\r\n\n21 CFR Part 106.100 (n)\r\n\n21 CFR Part 112.164\r\n\n21 CFR Part 114.100 (e)\r\n\n21 CFR Part 117.315\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.9\r\n\n21 CFR Part 129.80 (h)\r\n\n21 CFR Part 211.180\r\n\n21 CFR Part 212.110 (c)\r\n\n21 CFR Part 225.42 (b-8)\r\n\n21 CFR Part 225.58 (c\u2013d)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 225.110\r\n\n21 CFR Part 225.158\r\n\n21 CFR Part 225.202\r\n\n21 CFR Part 226.42 (a)\r\n\n21 CFR Part 226.58 (f)\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 226.115\r\n\n21 CFR Part 312.57\r\n\n21 CFR Part 312.62\r\n\n21 CFR Part 507.208\r\n\n21 CFR Part 606.160 (d)\r\n\n21 CFR Part 812.140 (d)\r\n\n21 CFR Part 820.180 (b)\r\n\n29 CFR Part 1910.120 (f)(8)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n40 CFR Part 141.33\r\n\n40 CFR Part 141.722\r\n\n40 CFR Part 262.11 (f)\r\n\n40 CFR Part 262.40\r\n\n40 CFR Part 262.213\r\n\n40 CFR Part 704 Subpart A\r\n\n40 CFR Part 717.15 (d)\r\n\n42 CFR Part 73.17 (c)\r\n\n42 CFR Part 93.313 (h)\r\n\n42 CFR Part 93.317\r\n\n42 CFR Part 493.1105\r\n\n42 CFR Part 493.1283\r\n\n45 CFR Part 164.105\r\n\n45 CFR Part 164.316\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\n61 FR 38806, 9 CFR Part 417.5\r\n\nA2LA C223 5.4\r\n\nA2LA C223 5.9\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.1.2\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.2.1\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.3.2\r\n\nABFT Accreditation Manual Sec. E-33\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.6\r\n\nACMG Technical Standards for Clinical Genetics Laboratories E2.1\r\n\nAIHA-LAP Policies 2022 2A.7.5.1\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7\r\n\nASTM E1578-18 E-17-4\r\n\nBRC GSFS, Issue 8, 3.3.2\r\n\nCAP Laboratory Accreditation Manual\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.3.4\r\n\nCJIS Security Policy 5.4.6\u20137\r\n\nCJIS Security Policy 5.5.2.1\r\n\nCLSI QMS22 2.8.3\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.4\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nE.U. Annex 11-7.1\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.1\r\n\nE.U. Commission Directive 2003\/94\/EC Article 11.4\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c\r\n\nEPA 815-R-05-004 Chap. III, Sec. 15\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nEPA ERLN Laboratory Requirements 4.9.18\r\n\nEPA ERLN Laboratory Requirements 4.11.17\r\n\nEPA QA\/G-5 2.1.9\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3\r\n\nICH GCP 4.9.5\r\n\nIFS Food 7, Part 2, 2.1.2.2\r\n\nIFS PACsecure 2, Part 2, 2.1.2.2\r\n\nISO 15189:2012 4.3\r\n\nISO\/IEC 17025:2017 8.4.2\r\n\nNIST 800-53, Rev. 5, AT-4\r\n\nNIST 800-53, Rev. 5, AU-11 and AU-11(1)\r\n\nNIST 800-53, Rev. 5, SI-12\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 10\r\n\nOSHA 1910.1020(d)(1)(i\u2013ii)\r\n\nOSHA 1910.1450(j)(2)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.2.3.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP 5.4\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c\r\n\nUSDA Sampling Procedures for PDP 6.5\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0\r\n\nWHO Technical Report Series, #986, Annex 2, 15.8\u20139\r\n\nWHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1\n\n\n31.4 The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.\n\n\nASTM E1578-18 E-17-6\r\nCJIS Security Policy 5.4.4\r\nNIST 800-53, Rev. 5, AU-8\r\nWHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n31.5 The system shall accurately reflect the system date and time in its use of electronic record time stamps.\n\n\nAPHL 2019 LIS Project Management Guidebook\r\nASTM E1578-18 E-17-7\r\nCJIS Security Policy 5.6.1\n\n31.6 The system shall require each and every user to be assigned a unique user ID.\n\n\n\nASTM E1578-18 E-17-8\r\n\n21 CFR Part 11.10 (e)\r\n\nCJIS Security Policy 5.4.5\r\n\nE.U. Annex 11-9\r\n\nNIST 800-53, Rev. 5, AU-9\n\n\n31.7 The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.\n\n\nCJIS Security Policy 5.4.2\r\nNIST 800-53, Rev. 5, AU-5\r\nNIST 800-53, Rev. 5, SI-4\n\n31.8 The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.\n\n\n\n32. Configuration management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 S-1-1\r\nAPHL 2019 LIS Project Management Guidebook\n\n32.1 The system shall provide tools to enter and manage user-configurable lookup or master data.\n\n\nASTM E1578-18 S-1-2\n\n32.2 The system shall allow authorized users to configure the specification limits for sample and instrument tests.\n\n\n45 CFR Part 162.1002\r\nUSDA Sampling Procedures for PDP 6.3.2\n\n32.3 The system shall allow system nomenclature to be configured to use specific data code sets\u2014such as the International Classification of Diseases or the Healthcare Common Procedure Coding System\u2014or mandated terminology to support regulatory requirements.\n\n\nASTM E1578-18 S-1-3\n\n32.4 The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.\n\n\nASTM E1578-18 S-1-4\n\n32.5 The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.\n\n\n21 CFR Part 211.100 (b)\r\n21 CFR Part 211.160 (a)\n\n32.6 The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.\n\n\n\n40 CFR Part 3.10\r\n\n40 CFR Part 3.2000\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C13.3\r\n\nASTM E1578-18 S-1-5\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.7 The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.\n\n\nASTM E1578-18 S-1-6\n\n32.8 The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.\n\n\nASTM E1578-18 S-1-7\n\n32.9 The system shall support configurable laboratory workflows based on appropriate laboratory process and procedure.\n\n\nASTM E1578-18 S-1-8\n\n32.10 The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of laboratory workflow.\n\n\n21 CFR Part 211.68\r\nAPHL 2019 LIS Project Management Guidebook\r\nASTM E1578-18 S-1-9\n\n32.11 The system should allow authorized personnel to perform revision control of lookup or master data.\n\n\nASTM E1578-18 S-1-10\r\nAPHL 2019 LIS Project Management Guidebook\n\n32.12 The system should provide a means for importing lookup or master data.\n\n\n\nAIHA-LAP Policies 2022 2A.7.8.4\r\n\nASTM E1578-18 S-1-11\r\n\nEPA ERLN Laboratory Requirements 4.11.6\r\n\nUSDA Data and Instrumentation for PDP 9.1\n\n\n32.13 The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.\n\n\nASTM E1578-18 S-1-12\n\n32.14 The system should allow calculated limits to be created and managed based on test results and relevant metadata.\n\n\nASTM E1578-18 S-1-13\r\nEPA ERLN Laboratory Requirements 3.2.6\r\nEPA ERLN Laboratory Requirements 4.9.11\n\n32.15 The system should provide a clear alert or notification upon entry of out-of-specification results.\n\n\nASTM E1578-18 S-1-14\n\n32.16 The system shall allow authorized personnel to update static and dynamic data.\n\n\nASTM E1578-18 S-1-15\n\n32.17 The system should allow workflow events and status changes to trigger one or more user-defined actions.\n\n\nASTM E1578-18 S-1-17\r\n\nCJIS Security Policy 5.7.1\r\n\nNIST 800-53, Rev. 5, AC-6(1)\r\n\nNIST 800-53, Rev. 5, CM-7\n\n\n32.18 The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.\n\n\nASTM E1578-18 S-1-18\r\nCAP Laboratory Accreditation Manual\n\n32.19 The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.\n\n\nASTM E1578-18 S-1-19\n\n32.20 The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.\n\n\n21 CFR Part 11.100 (a)\r\n\nASTM E1578-18 S-1-20\r\n\nE.U. Annex 11-14\r\n\nNIST 800-53, Rev. 5, CM-5(1)\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.21 The system should support rules governing electronic records and electronic signatures in regulated environments.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n10 CFR Part 20.2110\r\n\n10 CFR Part 30.51 (c-1\r\n\n21 CFR Part 11.10 (d)\r\n\n21 CFR Part 211.68\r\n\n42 CFR Part 73.11\r\n\n45 CFR Part 164.308\r\n\nA2LA C211 4.13.1.4\r\n\nA2LA C211 5.4.7.2\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.4.1\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\nASTM E1492-11 4.2.4\r\n\nASTM E1578-18 S-1-16\r\n\nASTM E1578-18 S-1-21\r\n\nCJIS Security Policy 5.5.2\r\n\nCLSI QMS22 2.4.3\r\n\nE.U. Annex 11-12\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nEPA ERLN Laboratory Requirements 4.9.4 and 4.9.14\r\n\nICH GCP 2.10\r\n\nISO\/IEC 17025:2017 7.11.3\r\n\nNIST 800-53, Rev. 5, CM-5 and CM-5(1)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\n\n\n32.22 The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.\n\n\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nCJIS Security Policy 5.5.2.2\u20133\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nNIST 800-53, Rev. 5, AC-2(11)\n\n\n32.23 The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.\n\n\nASTM E1578-18 S-1-22\r\nNIST 800-53, Rev. 5, IA-2(10)\n\n32.24 The system should support single sign-on such that a user can log in once and access all permitted functions and data.\n\n\n\n21 CFR Part 11.200 (a)\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d)\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCJIS Security Policy 5.6.1\r\n\nCLSI QMS22 2.4.2.2\r\n\nE.U. Annex 11-14\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nEPA ERLN Laboratory Requirements 4.9.4\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\nNIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\r\n\nNIST 800-53, Rev. 5, MA-4\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.25 The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.\n\n\n\n21 CFR Part 11.300 (a)\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, IA-4 and IA-5\n\n\n32.26 The system shall prevent the same combination of identification components from being used across more than one account.\n\n\n\n21 CFR Part 11.300 (b)\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCLSI QMS22 2.4.2\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, IA-5 and IA-5(1)\n\n\n32.27 The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.\n\n\nCJIS Security Policy 5.6.3.1\r\nNIST 800-53, Rev. 5, AC-2(3)\r\n\nNIST 800-53, Rev. 5, IA-4 and IA-5(1)\r\n\nNIST 800-53, Rev. 5, PS-4\n\n\n32.28 The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.\n\n\nCJIS Security Policy 5.5.2.2\r\nNIST 800-53, Rev. 5, AC-10\n\n32.29 The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.\n\n\nCJIS Security Policy 5.5.4\r\nNIST 800-53, Rev. 5, AC-8\n\n32.30 The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.\n\n\n\n21 CFR Part 11.300 (d)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\nA2LA C211 4.13.2.1\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCLSI QMS22 2.4.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, CM-5(1)\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\n\n\n32.31 The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.\n\n\n\n21 CFR Part 11.300 (d)\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCJIS Security Policy 5.5.3\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, AC-7\n\n\n32.32 The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.\n\n\n21 CFR Part 11.200 (a)\r\nASTM E1578-18 S-3-1\n\n32.33 The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.200 (a)\r\n\n21 CFR Part 211.68 (b)\r\n\n21 CFR Part 211.188 (b-11)\r\n\n21 CFR Part 211.194 (a-7 and a-8)\r\n\n21 CFR Part 212.50 (c-10)\r\n\n42 CFR Part 73.11\r\n\nASTM E1578-18 S-3-1\r\n\nCJIS Security Policy 5.6.3.2\r\n\nNIST 800-53, Rev. 5, IA-5\n\n\n32.34 The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.10 (d)\r\n\n42 CFR Part 73.11\r\n\n42 CFR Part 493.1231\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.514\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 S-1-25\r\n\nCJIS Security Policy 5.5.1\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nNIST 800-53, Rev. 5, AC-3\r\n\nNIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\n\n\n32.35 The system shall support the ability to initially assign new individual users to system groups, roles, or both.\n\n\n\n21 CFR Part 11.100 (a)\r\n\n45 CFR Part 164.312\r\n\nASTM E1578-18 S-1-24\r\n\nE.U. Annex 11-14\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.36 The system shall force a user's electronic signature to be unique and traceable to a specific user's account.\n\n\n21 CFR Part 11.100 (a)\r\nASTM E1578-18 S-1-24\r\n\n\n32.37 The system shall prevent the reuse or reassignment of a user's electronic signature.\n\n\n21 CFR Part 11.50\r\nE.U. Annex 11-14\n\n32.38 When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.\n\n\n\nASTM E1578-18 S-1-26\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nCLSI QMS22 2.8.5.3\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.39 The system should provide a means to migrate static data into the system.\n\n\nNIST 800-53, Rev. 5, IA-5(1)\r\nCLSI QMS22 2.4.2\n\n32.40 The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.\n\n\nNIST 800-53, Rev. 5, IA-6\n\n32.41 The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.\n\n\n\n33. System validation and commission \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 S-2-1\r\nCJIS Security Policy Appendix G.8\r\nNIST 800-53, Rev. 5, SA-4(3)\n\n33.1 The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.\n\n\nASTM E1578-18 S-2-2\r\nNIST 800-53, Rev. 5, SA-4(2)\n\n33.2 The vendor should be willing to provide access to source code through a suitable escrow.\n\n\nASTM E1578-18 S-2-3\n\n33.3 The system should be able to document a summary and evaluation of enterprise performance markers and processes.\n\n\n\nA2LA C211 5.4.7.2\r\n\nASTM E1578-18 S-2-4\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 7.11.5\r\n\nNIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5\n\n\n33.4 The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.\n\n\n\n21 CFR Part 11.10 (a)\r\n\n21 CFR Part 820.70 (i)\r\n\nA2LA C211 5.4.7.2\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nE.U. Annex 11-11\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 7.11.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 4.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)\r\n\nWHO Technical Report Series, #996, Annex 5, 10.2\n\n\n33.5 The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.\n\n\nASTM E1578-18 S-2-2\r\nCLSI QMS22 2.5\r\nE.U. Annex 11-4\r\nWHO Technical Report Series, #996, Annex 5, 10.3\u20137\n\n33.6 The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.\n\n\n\n34. System administration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 11.200 (a)\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d-5)\r\n\nASTM E1578-18 S-3-1\r\n\nCJIS Security Policy 5.5.5\r\n\nCLSI QMS22 2.4.2\r\n\nNIST 800-53, Rev. 5, AC-11 and AC-12\n\n\n34.1 The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.\n\n\nASTM E1578-18 S-3-2\n\n34.2 The system should provide a means for modifying personnel data in a batch.\n\n\nASTM E1578-18 S-3-3\n\n34.3 The system should support the storage of standard and industry-specific data formats.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.10 (d)\r\n\n21 CFR Part 211.68 (b)\r\n\n42 CFR Part 73.11\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.514\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 S-3-7\r\n\nCJIS Security Policy 5.5.1\r\n\nCJIS Security Policy 5.5.2.4\r\n\nCJIS Security Policy Appendix G.5\r\n\nCLSI QMS22 2.4.2\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nISO 15189:2012 5.10.2\r\n\nNIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\nNIST 800-53, Rev. 5, IA-2 and IA-8\r\n\nNIST 800-53, Rev. 5, MA-4\r\n\nNIST 800-53, Rev. 5, PS-4 and PS-5\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Administrative Procedures for the PDP 5.5.1.2\r\n\nWHO Technical Report Series, #996, Annex 5, 5.4 and Appendix 1\n\n\n34.4 The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.\n\n\nASTM E1578-18 S-3-8\n\n34.5 The vendor should provide maintenance agreements and support services for its applications and services.\n\n\nASTM E1578-18 S-3-9\r\n\nE.U. Annex 11-3.3\r\n\nNIST 800-53, Rev. 5, SA-16\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\n\n\n34.6 The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.10 (c)\r\n\n42 CFR Part 73.11\r\n\n45 CFR Part 164.310\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.4.3\r\n\nABFT Accreditation Manual Sec. D-5\u2013D-8\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\nASTM E1492-11 4.2.4\r\n\nCJIS Security Policy 5.5.2\r\n\nCJIS Security Policy 5.8.1\r\n\nEPA ERLN Laboratory Requirements 4.9.6\r\n\nE.U. Annex 11-7.1\r\n\nE.U. Annex 11-12\r\n\nISO 15189:2012 5.10.2\r\n\nISO\/IEC 17025:2017 7.11.3\r\n\nNIST 800-53, Rev. 5, MA-5\r\n\nNIST 800-53, Rev. 5, MP-2\r\n\nNIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\n\n\n34.7 The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)\n\n\nCJIS Security Policy 5.5.1\n\n34.8 The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n42 CFR Part 73.17\r\n\nASTM E1578-18 S-3-10\n\n\n34.9 The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n42 CFR Part 73.11\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 S-3-11\r\n\nCJIS Security Policy 5.10.4.1\r\n\nCLSI QMS22 2.1.4\r\n\nCLSI QMS22 2.6.1\r\n\nEPA ERLN Laboratory Requirements 4.9.13\r\n\nNIST 800-53, Rev. 5, SI-2(5)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n34.10 The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.\n\n\nASTM E1578-18 S-3-12\n\n34.11 The system shall provide a means for migrating data to a new release upon system upgrade.\n\n\n21 CFR Part 1.1154 (b)\r\nASTM E1578-18 S-3-13\n\n34.12 The system should be expedient with the retrieval of stored items.\n\n\n\n21 CFR Part 11.10 (b)\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nE.U. Annex 11-5\r\n\nE.U. Annex 11-8.1\n\n\n34.13 The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.\n\n\nASTM E1578-18 S-3-14\n\n34.14 The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.\n\n\nASTM E1578-18 S-3-15\r\n\nEPA ERLN Laboratory Requirements 4.9.13\r\n\nNIST 800-53, Rev. 5, CM-3(2)\r\n\nNIST 800-53, Rev. 5, SI-2\n\n\n34.15 The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.\n\n\n\n35. Cybersecurity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n42 CFR Part 493.1231\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d-9)\r\n\nASTM E1578-18 S-4-1\r\n\nCJIS Security Policy 5.6.4\r\n\nCJIS Security Policy 5.8.2.1\r\n\nCJIS Security Policy 5.10.1.2\r\n\nCJIS Security Policy Appendix G.6\r\n\nCLSI QMS22 2.2.3.2\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nNIST 800-53, Rev. 5, AC-17(2)\n\n\n35.1 The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.\n\n\n\n42 CFR Part 493.1231\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d)\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.6\r\n\nASTM E1578-18 S-4-2\r\n\nCJIS Security Policy 5.5.2.4\r\n\nCJIS Security Policy 5.10.1.2\r\n\nCJIS Security Policy Appendix G.6\r\n\nNIST 800-53, Rev. 5, SC-13 and SC-28(1)\n\n\n35.2 The system should support database encryption and be capable of recording the encryption status of the data contained within.\n\n\n42 CFR Part 493.1231\r\n\nCJIS Security Policy 5.6.2.2.1\r\n\nCLSI QMS22 2.4.2.2\r\n\nNIST 800-53, Rev. 5, AC-3\r\n\nNIST 800-53, Rev. 5, IA-2, IA-2(1\u20134), and IA-8\r\n\nNIST 800-53, Rev. 5, MA-4\n\n\n35.3 The system should be able to support multifactor authentication.\n\n\n45 CFR Part 170.202\r\n45 CFR Part 170.315 (h)\n\n35.4 The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information.\n\n\nNIST 800-53, Rev. 5, IA-7\n\n35.5 The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.\n\n\nNIST 800-53, Rev. 5, SC-15\n\n35.6 The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.\n\n\n\n36. Information privacy \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n45 CFR Part 164 Subpart E\r\nACMG Technical Standards for Clinical Genetics Laboratories G17.2\r\nASTM E1578-18 S-5-1\r\nCAP Laboratory Accreditation Manual\n\n36.1 The system shall comply with privacy protection compliance like that found in HIPAA provisions.\n\n\n\n10 CFR Part 20.2106 (d)\r\n\n45 CFR Part 164.105\r\n\n45 CFR Part 164 Subpart C\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 S-5-2\r\n\nICH GCP 2.11\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.3\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\n\n\n36.2 The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.\n\n\n45 CFR Part 164.514\r\nACMG Technical Standards for Clinical Genetics Laboratories C5.5\r\nCAP Laboratory Accreditation Manual\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3\n\n\n36.3 The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.\n\n\n45 CFR Part 164 Subpart E\r\n\nNIST 800-53, Rev. 5, AC-6\n\n\n36.4 The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.\n\n\nNIST 800-53, Rev. 5, SI-19(7)\n\n36.5 The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#32._Configuration_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#32._Configuration_management<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 20 September 2019, at 18:12.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 1,950 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","e972c3ebbff256d2241b0ba5e3831389_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Security_and_Integrity_of_Systems_and_Operations rootpage-LII_LIMSpec_Security_and_Integrity_of_Systems_and_Operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Security and Integrity of Systems and Operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"31._Data_integrity\">31. Data integrity<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 9.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.1<\/b> System functionality should support ALCOA principles.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.2<\/b> The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.305\" target=\"_blank\">42 CFR Part 93.305<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.310\" target=\"_blank\">42 CFR Part 93.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.3<\/b> The system shall securely maintain a true, readable copy of an instrument's original (raw) data for on-demand review.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.30\" target=\"_blank\">7 CFR Part 91.30<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.195\" target=\"_blank\">21 CFR Part 58.195<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (n)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.164<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.180\" target=\"_blank\">21 CFR Part 211.180<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 212.110 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42 (b-8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (c\u2013d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.202\" target=\"_blank\">21 CFR Part 225.202<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.115\" target=\"_blank\">21 CFR Part 226.115<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.208<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.160\" target=\"_blank\">21 CFR Part 606.160 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.180\" target=\"_blank\">21 CFR Part 820.180 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120 (f)(8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.722\" target=\"_blank\">40 CFR Part 141.722<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.11\" target=\"_blank\">40 CFR Part 262.11 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.40\" target=\"_blank\">40 CFR Part 262.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.213\" target=\"_blank\">40 CFR Part 262.213<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\/subpart-A\" target=\"_blank\">40 CFR Part 704 Subpart A<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/717.15\" target=\"_blank\">40 CFR Part 717.15 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.313\" target=\"_blank\">42 CFR Part 93.313 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.317\" target=\"_blank\">42 CFR Part 93.317<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1105\" target=\"_blank\">42 CFR Part 493.1105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.105\" target=\"_blank\">45 CFR Part 164.105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.316\" target=\"_blank\">45 CFR Part 164.316<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories E2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.4<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.18<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 2.1.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 2.1.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-11 and AU-11(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020(d)(1)(i\u2013ii)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(j)(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.8\u20139<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.4<\/b> The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.5<\/b> The system shall accurately reflect the system date and time in its use of electronic record time stamps.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-7<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.6<\/b> The system shall require each and every user to be assigned a unique user ID.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.7<\/b> The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.8<\/b> The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"32._Configuration_management\">32. Configuration management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.1<\/b> The system shall provide tools to enter and manage user-configurable lookup or master data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.2<\/b> The system shall allow authorized users to configure the specification limits for sample and instrument tests.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/162.1002\" target=\"_blank\">45 CFR Part 162.1002<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.3.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.3<\/b> The system shall allow system nomenclature to be configured to use specific data code sets\u2014such as the International Classification of Diseases or the Healthcare Common Procedure Coding System\u2014or mandated terminology to support regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.4<\/b> The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.5<\/b> The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.6<\/b> The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.10\" target=\"_blank\">40 CFR Part 3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.2000\" target=\"_blank\">40 CFR Part 3.2000<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C13.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.7<\/b> The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.8<\/b> The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.9<\/b> The system shall support configurable laboratory workflows based on appropriate laboratory process and procedure.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.10<\/b> The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of laboratory workflow.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.11<\/b> The system should allow authorized personnel to perform revision control of lookup or master data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-10<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.12<\/b> The system should provide a means for importing lookup or master data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 9.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.13<\/b> The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.14<\/b> The system should allow calculated limits to be created and managed based on test results and relevant metadata.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-13<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.15<\/b> The system should provide a clear alert or notification upon entry of out-of-specification results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.16<\/b> The system shall allow authorized personnel to update static and dynamic data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-15<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.17<\/b> The system should allow workflow events and status changes to trigger one or more user-defined actions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-17<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.18<\/b> The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-18<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.19<\/b> The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-19<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.20<\/b> The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.21<\/b> The system should support rules governing electronic records and electronic signatures in regulated environments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2110\" target=\"_blank\">10 CFR Part 20.2110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51 (c-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4 and 4.9.14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5 and CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.22<\/b> The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(11)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.23<\/b> The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-22<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2(10)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.24<\/b> The system should support single sign-on such that a user can log in once and access all permitted functions and data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(7) and AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.25<\/b> The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-4 and IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.26<\/b> The system shall prevent the same combination of identification components from being used across more than one account.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5 and IA-5(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.27<\/b> The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(3)<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-4 and IA-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PS-4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.28<\/b> The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.29<\/b> The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.30<\/b> The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.31<\/b> The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.32<\/b> The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.33<\/b> The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188 (b-11)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (a-7 and a-8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (c-10)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.34<\/b> The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.35<\/b> The system shall support the ability to initially assign new individual users to system groups, roles, or both.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.36<\/b> The system shall force a user's electronic signature to be unique and traceable to a specific user's account.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>32.37<\/b> The system shall prevent the reuse or reassignment of a user's electronic signature.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.50\" target=\"_blank\">21 CFR Part 11.50<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.38<\/b> When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-26<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.39<\/b> The system should provide a means to migrate static data into the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5(1)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.40<\/b> The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.41<\/b> The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"33._System_validation_and_commission\">33. System validation and commission<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.1<\/b> The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(2)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.2<\/b> The vendor should be willing to provide access to source code through a suitable escrow.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.3<\/b> The system should be able to document a summary and evaluation of enterprise performance markers and processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>33.4<\/b> The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>33.5<\/b> The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.3\u20137<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.6<\/b> The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"34._System_administration\">34. System administration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-11 and AC-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.1<\/b> The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.2<\/b> The system should provide a means for modifying personnel data in a batch.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.3<\/b> The system should support the storage of standard and industry-specific data formats.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(7) and AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2 and IA-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PS-4 and PS-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 5.4 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.4<\/b> The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.5<\/b> The vendor should provide maintenance agreements and support services for its applications and services.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-9<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.6<\/b> The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D-5\u2013D-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MP-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.7<\/b> The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.8<\/b> The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.9<\/b> The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2(5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.10<\/b> The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.11<\/b> The system shall provide a means for migrating data to a new release upon system upgrade.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-13<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.12<\/b> The system should be expedient with the retrieval of stored items.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.13<\/b> The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.14<\/b> The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-15<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-3(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.15<\/b> The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"35._Cybersecurity\">35. Cybersecurity<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-9)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-4-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.8.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>35.1<\/b> The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-4-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-13 and SC-28(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>35.2<\/b> The system should support database encryption and be capable of recording the encryption status of the data contained within.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-2(1\u20134), and IA-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>35.3<\/b> The system should be able to support multifactor authentication.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.202\" target=\"_blank\">45 CFR Part 170.202<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (h)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>35.4<\/b> The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>35.5<\/b> The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-15<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>35.6<\/b> The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"36._Information_privacy\">36. Information privacy<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-E\" target=\"_blank\">45 CFR Part 164 Subpart E<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G17.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-5-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.1<\/b> The system shall comply with privacy protection compliance like that found in HIPAA provisions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2106\" target=\"_blank\">10 CFR Part 20.2106 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.105\" target=\"_blank\">45 CFR Part 164.105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-C\" target=\"_blank\">45 CFR Part 164 Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-5-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 2.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>36.2<\/b> The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>36.3<\/b> The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-E\" target=\"_blank\">45 CFR Part 164 Subpart E<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>36.4<\/b> The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-19(7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.5<\/b> The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173546\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.060 seconds\nReal time usage: 0.064 seconds\nPreprocessor visited node count: 478\/1000000\nPost\u2010expand include size: 78225\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 13.410 1 -total\n 20.15% 2.702 1 Template:LIMSpec\/Configuration_management\n 15.95% 2.139 1 Template:LIMSpec\/System_validation_and_commission\n 15.72% 2.108 1 Template:LIMSpec\/Data_integrity\n 14.72% 1.974 1 Template:LIMSpec\/System_administration\n 13.47% 1.807 1 Template:LIMSpec\/Information_privacy\n 13.26% 1.778 1 Template:LIMSpec\/Cybersecurity\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11215-0!canonical and timestamp 20221202173546 and revision id 36393. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#32._Configuration_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#32._Configuration_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","e972c3ebbff256d2241b0ba5e3831389_images":[],"e972c3ebbff256d2241b0ba5e3831389_timestamp":1670002546,"eedafbce6e4049ac527deb43a1e2311d_type":"article","eedafbce6e4049ac527deb43a1e2311d_title":"31. Data integrity","eedafbce6e4049ac527deb43a1e2311d_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#31._Data_integrity","eedafbce6e4049ac527deb43a1e2311d_plaintext":"\n\nLII:LIMSpec\/Security and Integrity of Systems and OperationsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.\n\n31. Data integrity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-17-1\r\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\nWHO Technical Report Series, #996, Annex 5, 9.1\n\n31.1 System functionality should support ALCOA principles.\n\n\n\n61 FR 38806, 9 CFR Part 417.5\r\n\nASTM E1578-18 E-17-2\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nA2LA C211 4.13.2.3\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nNIST 800-53, Rev. 5, SI-12\n\n\n31.2 The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.\n\n\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 58.190\r\n\n42 CFR Part 93.305\r\n\n42 CFR Part 93.310\r\n\nASTM E1578-18 E-17-3\r\n\nCLSI QMS22 2.2.2.2\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\r\n\nNIST 800-53, Rev. 5, SI-12\r\n\nOECD GLP Principles 10\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\r\n\nUSDA Data and Instrumentation for PDP 8.1.3\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n\n31.3 The system shall securely maintain a true, readable copy of an instrument's original (raw) data for on-demand review.\n\n\n\n7 CFR Part 91.30\r\n\n7 CFR Part 331.17 (c)\r\n\n9 CFR Part 2.35\r\n\n9 CFR Part 121.17 (c)\r\n\n10 CFR Part 20.2103\u201310\r\n\n10 CFR Part 30.34 (g)\r\n\n10 CFR Part 30.51\u20132\r\n\n21 CFR Part 1.1154 (a)\r\n\n21 CFR Part 11.10 (c)\r\n\n21 CFR Part 58.195\r\n\n21 CFR Part 106.100 (n)\r\n\n21 CFR Part 112.164\r\n\n21 CFR Part 114.100 (e)\r\n\n21 CFR Part 117.315\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.9\r\n\n21 CFR Part 129.80 (h)\r\n\n21 CFR Part 211.180\r\n\n21 CFR Part 212.110 (c)\r\n\n21 CFR Part 225.42 (b-8)\r\n\n21 CFR Part 225.58 (c\u2013d)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 225.110\r\n\n21 CFR Part 225.158\r\n\n21 CFR Part 225.202\r\n\n21 CFR Part 226.42 (a)\r\n\n21 CFR Part 226.58 (f)\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 226.115\r\n\n21 CFR Part 312.57\r\n\n21 CFR Part 312.62\r\n\n21 CFR Part 507.208\r\n\n21 CFR Part 606.160 (d)\r\n\n21 CFR Part 812.140 (d)\r\n\n21 CFR Part 820.180 (b)\r\n\n29 CFR Part 1910.120 (f)(8)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n40 CFR Part 141.33\r\n\n40 CFR Part 141.722\r\n\n40 CFR Part 262.11 (f)\r\n\n40 CFR Part 262.40\r\n\n40 CFR Part 262.213\r\n\n40 CFR Part 704 Subpart A\r\n\n40 CFR Part 717.15 (d)\r\n\n42 CFR Part 73.17 (c)\r\n\n42 CFR Part 93.313 (h)\r\n\n42 CFR Part 93.317\r\n\n42 CFR Part 493.1105\r\n\n42 CFR Part 493.1283\r\n\n45 CFR Part 164.105\r\n\n45 CFR Part 164.316\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\n61 FR 38806, 9 CFR Part 417.5\r\n\nA2LA C223 5.4\r\n\nA2LA C223 5.9\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.1.2\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.2.1\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.3.2\r\n\nABFT Accreditation Manual Sec. E-33\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.6\r\n\nACMG Technical Standards for Clinical Genetics Laboratories E2.1\r\n\nAIHA-LAP Policies 2022 2A.7.5.1\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7\r\n\nASTM E1578-18 E-17-4\r\n\nBRC GSFS, Issue 8, 3.3.2\r\n\nCAP Laboratory Accreditation Manual\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.3.4\r\n\nCJIS Security Policy 5.4.6\u20137\r\n\nCJIS Security Policy 5.5.2.1\r\n\nCLSI QMS22 2.8.3\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.4\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nE.U. Annex 11-7.1\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.1\r\n\nE.U. Commission Directive 2003\/94\/EC Article 11.4\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c\r\n\nEPA 815-R-05-004 Chap. III, Sec. 15\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nEPA ERLN Laboratory Requirements 4.9.18\r\n\nEPA ERLN Laboratory Requirements 4.11.17\r\n\nEPA QA\/G-5 2.1.9\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3\r\n\nICH GCP 4.9.5\r\n\nIFS Food 7, Part 2, 2.1.2.2\r\n\nIFS PACsecure 2, Part 2, 2.1.2.2\r\n\nISO 15189:2012 4.3\r\n\nISO\/IEC 17025:2017 8.4.2\r\n\nNIST 800-53, Rev. 5, AT-4\r\n\nNIST 800-53, Rev. 5, AU-11 and AU-11(1)\r\n\nNIST 800-53, Rev. 5, SI-12\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 10\r\n\nOSHA 1910.1020(d)(1)(i\u2013ii)\r\n\nOSHA 1910.1450(j)(2)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.2.3.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP 5.4\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c\r\n\nUSDA Sampling Procedures for PDP 6.5\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0\r\n\nWHO Technical Report Series, #986, Annex 2, 15.8\u20139\r\n\nWHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1\n\n\n31.4 The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.\n\n\nASTM E1578-18 E-17-6\r\nCJIS Security Policy 5.4.4\r\nNIST 800-53, Rev. 5, AU-8\r\nWHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n31.5 The system shall accurately reflect the system date and time in its use of electronic record time stamps.\n\n\nAPHL 2019 LIS Project Management Guidebook\r\nASTM E1578-18 E-17-7\r\nCJIS Security Policy 5.6.1\n\n31.6 The system shall require each and every user to be assigned a unique user ID.\n\n\n\nASTM E1578-18 E-17-8\r\n\n21 CFR Part 11.10 (e)\r\n\nCJIS Security Policy 5.4.5\r\n\nE.U. Annex 11-9\r\n\nNIST 800-53, Rev. 5, AU-9\n\n\n31.7 The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.\n\n\nCJIS Security Policy 5.4.2\r\nNIST 800-53, Rev. 5, AU-5\r\nNIST 800-53, Rev. 5, SI-4\n\n31.8 The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.\n\n\n\n32. Configuration management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 S-1-1\r\nAPHL 2019 LIS Project Management Guidebook\n\n32.1 The system shall provide tools to enter and manage user-configurable lookup or master data.\n\n\nASTM E1578-18 S-1-2\n\n32.2 The system shall allow authorized users to configure the specification limits for sample and instrument tests.\n\n\n45 CFR Part 162.1002\r\nUSDA Sampling Procedures for PDP 6.3.2\n\n32.3 The system shall allow system nomenclature to be configured to use specific data code sets\u2014such as the International Classification of Diseases or the Healthcare Common Procedure Coding System\u2014or mandated terminology to support regulatory requirements.\n\n\nASTM E1578-18 S-1-3\n\n32.4 The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.\n\n\nASTM E1578-18 S-1-4\n\n32.5 The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.\n\n\n21 CFR Part 211.100 (b)\r\n21 CFR Part 211.160 (a)\n\n32.6 The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.\n\n\n\n40 CFR Part 3.10\r\n\n40 CFR Part 3.2000\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C13.3\r\n\nASTM E1578-18 S-1-5\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.7 The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.\n\n\nASTM E1578-18 S-1-6\n\n32.8 The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.\n\n\nASTM E1578-18 S-1-7\n\n32.9 The system shall support configurable laboratory workflows based on appropriate laboratory process and procedure.\n\n\nASTM E1578-18 S-1-8\n\n32.10 The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of laboratory workflow.\n\n\n21 CFR Part 211.68\r\nAPHL 2019 LIS Project Management Guidebook\r\nASTM E1578-18 S-1-9\n\n32.11 The system should allow authorized personnel to perform revision control of lookup or master data.\n\n\nASTM E1578-18 S-1-10\r\nAPHL 2019 LIS Project Management Guidebook\n\n32.12 The system should provide a means for importing lookup or master data.\n\n\n\nAIHA-LAP Policies 2022 2A.7.8.4\r\n\nASTM E1578-18 S-1-11\r\n\nEPA ERLN Laboratory Requirements 4.11.6\r\n\nUSDA Data and Instrumentation for PDP 9.1\n\n\n32.13 The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.\n\n\nASTM E1578-18 S-1-12\n\n32.14 The system should allow calculated limits to be created and managed based on test results and relevant metadata.\n\n\nASTM E1578-18 S-1-13\r\nEPA ERLN Laboratory Requirements 3.2.6\r\nEPA ERLN Laboratory Requirements 4.9.11\n\n32.15 The system should provide a clear alert or notification upon entry of out-of-specification results.\n\n\nASTM E1578-18 S-1-14\n\n32.16 The system shall allow authorized personnel to update static and dynamic data.\n\n\nASTM E1578-18 S-1-15\n\n32.17 The system should allow workflow events and status changes to trigger one or more user-defined actions.\n\n\nASTM E1578-18 S-1-17\r\n\nCJIS Security Policy 5.7.1\r\n\nNIST 800-53, Rev. 5, AC-6(1)\r\n\nNIST 800-53, Rev. 5, CM-7\n\n\n32.18 The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.\n\n\nASTM E1578-18 S-1-18\r\nCAP Laboratory Accreditation Manual\n\n32.19 The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.\n\n\nASTM E1578-18 S-1-19\n\n32.20 The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.\n\n\n21 CFR Part 11.100 (a)\r\n\nASTM E1578-18 S-1-20\r\n\nE.U. Annex 11-14\r\n\nNIST 800-53, Rev. 5, CM-5(1)\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.21 The system should support rules governing electronic records and electronic signatures in regulated environments.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n10 CFR Part 20.2110\r\n\n10 CFR Part 30.51 (c-1\r\n\n21 CFR Part 11.10 (d)\r\n\n21 CFR Part 211.68\r\n\n42 CFR Part 73.11\r\n\n45 CFR Part 164.308\r\n\nA2LA C211 4.13.1.4\r\n\nA2LA C211 5.4.7.2\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.4.1\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\nASTM E1492-11 4.2.4\r\n\nASTM E1578-18 S-1-16\r\n\nASTM E1578-18 S-1-21\r\n\nCJIS Security Policy 5.5.2\r\n\nCLSI QMS22 2.4.3\r\n\nE.U. Annex 11-12\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nEPA ERLN Laboratory Requirements 4.9.4 and 4.9.14\r\n\nICH GCP 2.10\r\n\nISO\/IEC 17025:2017 7.11.3\r\n\nNIST 800-53, Rev. 5, CM-5 and CM-5(1)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\n\n\n32.22 The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.\n\n\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nCJIS Security Policy 5.5.2.2\u20133\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nNIST 800-53, Rev. 5, AC-2(11)\n\n\n32.23 The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.\n\n\nASTM E1578-18 S-1-22\r\nNIST 800-53, Rev. 5, IA-2(10)\n\n32.24 The system should support single sign-on such that a user can log in once and access all permitted functions and data.\n\n\n\n21 CFR Part 11.200 (a)\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d)\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCJIS Security Policy 5.6.1\r\n\nCLSI QMS22 2.4.2.2\r\n\nE.U. Annex 11-14\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nEPA ERLN Laboratory Requirements 4.9.4\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\nNIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\r\n\nNIST 800-53, Rev. 5, MA-4\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.25 The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.\n\n\n\n21 CFR Part 11.300 (a)\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, IA-4 and IA-5\n\n\n32.26 The system shall prevent the same combination of identification components from being used across more than one account.\n\n\n\n21 CFR Part 11.300 (b)\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCLSI QMS22 2.4.2\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, IA-5 and IA-5(1)\n\n\n32.27 The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.\n\n\nCJIS Security Policy 5.6.3.1\r\nNIST 800-53, Rev. 5, AC-2(3)\r\n\nNIST 800-53, Rev. 5, IA-4 and IA-5(1)\r\n\nNIST 800-53, Rev. 5, PS-4\n\n\n32.28 The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.\n\n\nCJIS Security Policy 5.5.2.2\r\nNIST 800-53, Rev. 5, AC-10\n\n32.29 The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.\n\n\nCJIS Security Policy 5.5.4\r\nNIST 800-53, Rev. 5, AC-8\n\n32.30 The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.\n\n\n\n21 CFR Part 11.300 (d)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\nA2LA C211 4.13.2.1\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCLSI QMS22 2.4.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, CM-5(1)\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\n\n\n32.31 The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.\n\n\n\n21 CFR Part 11.300 (d)\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCJIS Security Policy 5.5.3\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, AC-7\n\n\n32.32 The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.\n\n\n21 CFR Part 11.200 (a)\r\nASTM E1578-18 S-3-1\n\n32.33 The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.200 (a)\r\n\n21 CFR Part 211.68 (b)\r\n\n21 CFR Part 211.188 (b-11)\r\n\n21 CFR Part 211.194 (a-7 and a-8)\r\n\n21 CFR Part 212.50 (c-10)\r\n\n42 CFR Part 73.11\r\n\nASTM E1578-18 S-3-1\r\n\nCJIS Security Policy 5.6.3.2\r\n\nNIST 800-53, Rev. 5, IA-5\n\n\n32.34 The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.10 (d)\r\n\n42 CFR Part 73.11\r\n\n42 CFR Part 493.1231\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.514\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 S-1-25\r\n\nCJIS Security Policy 5.5.1\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nNIST 800-53, Rev. 5, AC-3\r\n\nNIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\n\n\n32.35 The system shall support the ability to initially assign new individual users to system groups, roles, or both.\n\n\n\n21 CFR Part 11.100 (a)\r\n\n45 CFR Part 164.312\r\n\nASTM E1578-18 S-1-24\r\n\nE.U. Annex 11-14\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.36 The system shall force a user's electronic signature to be unique and traceable to a specific user's account.\n\n\n21 CFR Part 11.100 (a)\r\nASTM E1578-18 S-1-24\r\n\n\n32.37 The system shall prevent the reuse or reassignment of a user's electronic signature.\n\n\n21 CFR Part 11.50\r\nE.U. Annex 11-14\n\n32.38 When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.\n\n\n\nASTM E1578-18 S-1-26\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nCLSI QMS22 2.8.5.3\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.39 The system should provide a means to migrate static data into the system.\n\n\nNIST 800-53, Rev. 5, IA-5(1)\r\nCLSI QMS22 2.4.2\n\n32.40 The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.\n\n\nNIST 800-53, Rev. 5, IA-6\n\n32.41 The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.\n\n\n\n33. System validation and commission \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 S-2-1\r\nCJIS Security Policy Appendix G.8\r\nNIST 800-53, Rev. 5, SA-4(3)\n\n33.1 The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.\n\n\nASTM E1578-18 S-2-2\r\nNIST 800-53, Rev. 5, SA-4(2)\n\n33.2 The vendor should be willing to provide access to source code through a suitable escrow.\n\n\nASTM E1578-18 S-2-3\n\n33.3 The system should be able to document a summary and evaluation of enterprise performance markers and processes.\n\n\n\nA2LA C211 5.4.7.2\r\n\nASTM E1578-18 S-2-4\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 7.11.5\r\n\nNIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5\n\n\n33.4 The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.\n\n\n\n21 CFR Part 11.10 (a)\r\n\n21 CFR Part 820.70 (i)\r\n\nA2LA C211 5.4.7.2\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nE.U. Annex 11-11\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 7.11.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 4.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)\r\n\nWHO Technical Report Series, #996, Annex 5, 10.2\n\n\n33.5 The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.\n\n\nASTM E1578-18 S-2-2\r\nCLSI QMS22 2.5\r\nE.U. Annex 11-4\r\nWHO Technical Report Series, #996, Annex 5, 10.3\u20137\n\n33.6 The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.\n\n\n\n34. System administration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 11.200 (a)\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d-5)\r\n\nASTM E1578-18 S-3-1\r\n\nCJIS Security Policy 5.5.5\r\n\nCLSI QMS22 2.4.2\r\n\nNIST 800-53, Rev. 5, AC-11 and AC-12\n\n\n34.1 The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.\n\n\nASTM E1578-18 S-3-2\n\n34.2 The system should provide a means for modifying personnel data in a batch.\n\n\nASTM E1578-18 S-3-3\n\n34.3 The system should support the storage of standard and industry-specific data formats.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.10 (d)\r\n\n21 CFR Part 211.68 (b)\r\n\n42 CFR Part 73.11\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.514\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 S-3-7\r\n\nCJIS Security Policy 5.5.1\r\n\nCJIS Security Policy 5.5.2.4\r\n\nCJIS Security Policy Appendix G.5\r\n\nCLSI QMS22 2.4.2\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nISO 15189:2012 5.10.2\r\n\nNIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\nNIST 800-53, Rev. 5, IA-2 and IA-8\r\n\nNIST 800-53, Rev. 5, MA-4\r\n\nNIST 800-53, Rev. 5, PS-4 and PS-5\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Administrative Procedures for the PDP 5.5.1.2\r\n\nWHO Technical Report Series, #996, Annex 5, 5.4 and Appendix 1\n\n\n34.4 The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.\n\n\nASTM E1578-18 S-3-8\n\n34.5 The vendor should provide maintenance agreements and support services for its applications and services.\n\n\nASTM E1578-18 S-3-9\r\n\nE.U. Annex 11-3.3\r\n\nNIST 800-53, Rev. 5, SA-16\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\n\n\n34.6 The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.10 (c)\r\n\n42 CFR Part 73.11\r\n\n45 CFR Part 164.310\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.4.3\r\n\nABFT Accreditation Manual Sec. D-5\u2013D-8\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\nASTM E1492-11 4.2.4\r\n\nCJIS Security Policy 5.5.2\r\n\nCJIS Security Policy 5.8.1\r\n\nEPA ERLN Laboratory Requirements 4.9.6\r\n\nE.U. Annex 11-7.1\r\n\nE.U. Annex 11-12\r\n\nISO 15189:2012 5.10.2\r\n\nISO\/IEC 17025:2017 7.11.3\r\n\nNIST 800-53, Rev. 5, MA-5\r\n\nNIST 800-53, Rev. 5, MP-2\r\n\nNIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\n\n\n34.7 The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)\n\n\nCJIS Security Policy 5.5.1\n\n34.8 The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n42 CFR Part 73.17\r\n\nASTM E1578-18 S-3-10\n\n\n34.9 The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n42 CFR Part 73.11\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 S-3-11\r\n\nCJIS Security Policy 5.10.4.1\r\n\nCLSI QMS22 2.1.4\r\n\nCLSI QMS22 2.6.1\r\n\nEPA ERLN Laboratory Requirements 4.9.13\r\n\nNIST 800-53, Rev. 5, SI-2(5)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n34.10 The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.\n\n\nASTM E1578-18 S-3-12\n\n34.11 The system shall provide a means for migrating data to a new release upon system upgrade.\n\n\n21 CFR Part 1.1154 (b)\r\nASTM E1578-18 S-3-13\n\n34.12 The system should be expedient with the retrieval of stored items.\n\n\n\n21 CFR Part 11.10 (b)\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nE.U. Annex 11-5\r\n\nE.U. Annex 11-8.1\n\n\n34.13 The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.\n\n\nASTM E1578-18 S-3-14\n\n34.14 The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.\n\n\nASTM E1578-18 S-3-15\r\n\nEPA ERLN Laboratory Requirements 4.9.13\r\n\nNIST 800-53, Rev. 5, CM-3(2)\r\n\nNIST 800-53, Rev. 5, SI-2\n\n\n34.15 The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.\n\n\n\n35. Cybersecurity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n42 CFR Part 493.1231\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d-9)\r\n\nASTM E1578-18 S-4-1\r\n\nCJIS Security Policy 5.6.4\r\n\nCJIS Security Policy 5.8.2.1\r\n\nCJIS Security Policy 5.10.1.2\r\n\nCJIS Security Policy Appendix G.6\r\n\nCLSI QMS22 2.2.3.2\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nNIST 800-53, Rev. 5, AC-17(2)\n\n\n35.1 The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.\n\n\n\n42 CFR Part 493.1231\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d)\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.6\r\n\nASTM E1578-18 S-4-2\r\n\nCJIS Security Policy 5.5.2.4\r\n\nCJIS Security Policy 5.10.1.2\r\n\nCJIS Security Policy Appendix G.6\r\n\nNIST 800-53, Rev. 5, SC-13 and SC-28(1)\n\n\n35.2 The system should support database encryption and be capable of recording the encryption status of the data contained within.\n\n\n42 CFR Part 493.1231\r\n\nCJIS Security Policy 5.6.2.2.1\r\n\nCLSI QMS22 2.4.2.2\r\n\nNIST 800-53, Rev. 5, AC-3\r\n\nNIST 800-53, Rev. 5, IA-2, IA-2(1\u20134), and IA-8\r\n\nNIST 800-53, Rev. 5, MA-4\n\n\n35.3 The system should be able to support multifactor authentication.\n\n\n45 CFR Part 170.202\r\n45 CFR Part 170.315 (h)\n\n35.4 The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information.\n\n\nNIST 800-53, Rev. 5, IA-7\n\n35.5 The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.\n\n\nNIST 800-53, Rev. 5, SC-15\n\n35.6 The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.\n\n\n\n36. Information privacy \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n45 CFR Part 164 Subpart E\r\nACMG Technical Standards for Clinical Genetics Laboratories G17.2\r\nASTM E1578-18 S-5-1\r\nCAP Laboratory Accreditation Manual\n\n36.1 The system shall comply with privacy protection compliance like that found in HIPAA provisions.\n\n\n\n10 CFR Part 20.2106 (d)\r\n\n45 CFR Part 164.105\r\n\n45 CFR Part 164 Subpart C\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 S-5-2\r\n\nICH GCP 2.11\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.3\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\n\n\n36.2 The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.\n\n\n45 CFR Part 164.514\r\nACMG Technical Standards for Clinical Genetics Laboratories C5.5\r\nCAP Laboratory Accreditation Manual\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3\n\n\n36.3 The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.\n\n\n45 CFR Part 164 Subpart E\r\n\nNIST 800-53, Rev. 5, AC-6\n\n\n36.4 The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.\n\n\nNIST 800-53, Rev. 5, SI-19(7)\n\n36.5 The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#31._Data_integrity\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#31._Data_integrity<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 20 September 2019, at 18:12.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 1,950 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","eedafbce6e4049ac527deb43a1e2311d_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Security_and_Integrity_of_Systems_and_Operations rootpage-LII_LIMSpec_Security_and_Integrity_of_Systems_and_Operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Security and Integrity of Systems and Operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"31._Data_integrity\">31. Data integrity<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 9.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.1<\/b> System functionality should support ALCOA principles.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.2<\/b> The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.305\" target=\"_blank\">42 CFR Part 93.305<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.310\" target=\"_blank\">42 CFR Part 93.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.3<\/b> The system shall securely maintain a true, readable copy of an instrument's original (raw) data for on-demand review.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.30\" target=\"_blank\">7 CFR Part 91.30<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.195\" target=\"_blank\">21 CFR Part 58.195<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (n)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.164<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.180\" target=\"_blank\">21 CFR Part 211.180<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 212.110 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42 (b-8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (c\u2013d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.202\" target=\"_blank\">21 CFR Part 225.202<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.115\" target=\"_blank\">21 CFR Part 226.115<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.208<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.160\" target=\"_blank\">21 CFR Part 606.160 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.180\" target=\"_blank\">21 CFR Part 820.180 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120 (f)(8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.722\" target=\"_blank\">40 CFR Part 141.722<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.11\" target=\"_blank\">40 CFR Part 262.11 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.40\" target=\"_blank\">40 CFR Part 262.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.213\" target=\"_blank\">40 CFR Part 262.213<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\/subpart-A\" target=\"_blank\">40 CFR Part 704 Subpart A<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/717.15\" target=\"_blank\">40 CFR Part 717.15 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.313\" target=\"_blank\">42 CFR Part 93.313 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.317\" target=\"_blank\">42 CFR Part 93.317<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1105\" target=\"_blank\">42 CFR Part 493.1105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.105\" target=\"_blank\">45 CFR Part 164.105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.316\" target=\"_blank\">45 CFR Part 164.316<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories E2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.4<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.18<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 2.1.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 2.1.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-11 and AU-11(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020(d)(1)(i\u2013ii)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(j)(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.8\u20139<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.4<\/b> The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.5<\/b> The system shall accurately reflect the system date and time in its use of electronic record time stamps.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-7<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.6<\/b> The system shall require each and every user to be assigned a unique user ID.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.7<\/b> The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.8<\/b> The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"32._Configuration_management\">32. Configuration management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.1<\/b> The system shall provide tools to enter and manage user-configurable lookup or master data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.2<\/b> The system shall allow authorized users to configure the specification limits for sample and instrument tests.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/162.1002\" target=\"_blank\">45 CFR Part 162.1002<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.3.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.3<\/b> The system shall allow system nomenclature to be configured to use specific data code sets\u2014such as the International Classification of Diseases or the Healthcare Common Procedure Coding System\u2014or mandated terminology to support regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.4<\/b> The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.5<\/b> The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.6<\/b> The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.10\" target=\"_blank\">40 CFR Part 3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.2000\" target=\"_blank\">40 CFR Part 3.2000<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C13.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.7<\/b> The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.8<\/b> The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.9<\/b> The system shall support configurable laboratory workflows based on appropriate laboratory process and procedure.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.10<\/b> The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of laboratory workflow.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.11<\/b> The system should allow authorized personnel to perform revision control of lookup or master data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-10<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.12<\/b> The system should provide a means for importing lookup or master data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 9.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.13<\/b> The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.14<\/b> The system should allow calculated limits to be created and managed based on test results and relevant metadata.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-13<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.15<\/b> The system should provide a clear alert or notification upon entry of out-of-specification results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.16<\/b> The system shall allow authorized personnel to update static and dynamic data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-15<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.17<\/b> The system should allow workflow events and status changes to trigger one or more user-defined actions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-17<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.18<\/b> The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-18<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.19<\/b> The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-19<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.20<\/b> The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.21<\/b> The system should support rules governing electronic records and electronic signatures in regulated environments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2110\" target=\"_blank\">10 CFR Part 20.2110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51 (c-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4 and 4.9.14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5 and CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.22<\/b> The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(11)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.23<\/b> The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-22<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2(10)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.24<\/b> The system should support single sign-on such that a user can log in once and access all permitted functions and data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(7) and AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.25<\/b> The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-4 and IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.26<\/b> The system shall prevent the same combination of identification components from being used across more than one account.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5 and IA-5(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.27<\/b> The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(3)<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-4 and IA-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PS-4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.28<\/b> The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.29<\/b> The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.30<\/b> The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.31<\/b> The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.32<\/b> The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.33<\/b> The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188 (b-11)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (a-7 and a-8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (c-10)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.34<\/b> The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.35<\/b> The system shall support the ability to initially assign new individual users to system groups, roles, or both.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.36<\/b> The system shall force a user's electronic signature to be unique and traceable to a specific user's account.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>32.37<\/b> The system shall prevent the reuse or reassignment of a user's electronic signature.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.50\" target=\"_blank\">21 CFR Part 11.50<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.38<\/b> When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-26<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.39<\/b> The system should provide a means to migrate static data into the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5(1)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.40<\/b> The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.41<\/b> The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"33._System_validation_and_commission\">33. System validation and commission<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.1<\/b> The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(2)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.2<\/b> The vendor should be willing to provide access to source code through a suitable escrow.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.3<\/b> The system should be able to document a summary and evaluation of enterprise performance markers and processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>33.4<\/b> The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>33.5<\/b> The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.3\u20137<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.6<\/b> The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"34._System_administration\">34. System administration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-11 and AC-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.1<\/b> The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.2<\/b> The system should provide a means for modifying personnel data in a batch.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.3<\/b> The system should support the storage of standard and industry-specific data formats.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(7) and AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2 and IA-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PS-4 and PS-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 5.4 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.4<\/b> The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.5<\/b> The vendor should provide maintenance agreements and support services for its applications and services.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-9<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.6<\/b> The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D-5\u2013D-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MP-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.7<\/b> The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.8<\/b> The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.9<\/b> The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2(5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.10<\/b> The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.11<\/b> The system shall provide a means for migrating data to a new release upon system upgrade.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-13<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.12<\/b> The system should be expedient with the retrieval of stored items.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.13<\/b> The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.14<\/b> The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-15<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-3(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.15<\/b> The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"35._Cybersecurity\">35. Cybersecurity<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-9)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-4-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.8.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>35.1<\/b> The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-4-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-13 and SC-28(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>35.2<\/b> The system should support database encryption and be capable of recording the encryption status of the data contained within.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-2(1\u20134), and IA-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>35.3<\/b> The system should be able to support multifactor authentication.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.202\" target=\"_blank\">45 CFR Part 170.202<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (h)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>35.4<\/b> The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>35.5<\/b> The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-15<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>35.6<\/b> The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"36._Information_privacy\">36. Information privacy<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-E\" target=\"_blank\">45 CFR Part 164 Subpart E<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G17.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-5-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.1<\/b> The system shall comply with privacy protection compliance like that found in HIPAA provisions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2106\" target=\"_blank\">10 CFR Part 20.2106 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.105\" target=\"_blank\">45 CFR Part 164.105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-C\" target=\"_blank\">45 CFR Part 164 Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-5-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 2.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>36.2<\/b> The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>36.3<\/b> The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-E\" target=\"_blank\">45 CFR Part 164 Subpart E<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>36.4<\/b> The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-19(7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.5<\/b> The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173546\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.060 seconds\nReal time usage: 0.064 seconds\nPreprocessor visited node count: 478\/1000000\nPost\u2010expand include size: 78225\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 13.410 1 -total\n 20.15% 2.702 1 Template:LIMSpec\/Configuration_management\n 15.95% 2.139 1 Template:LIMSpec\/System_validation_and_commission\n 15.72% 2.108 1 Template:LIMSpec\/Data_integrity\n 14.72% 1.974 1 Template:LIMSpec\/System_administration\n 13.47% 1.807 1 Template:LIMSpec\/Information_privacy\n 13.26% 1.778 1 Template:LIMSpec\/Cybersecurity\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11215-0!canonical and timestamp 20221202173546 and revision id 36393. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#31._Data_integrity\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#31._Data_integrity<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","eedafbce6e4049ac527deb43a1e2311d_images":[],"eedafbce6e4049ac527deb43a1e2311d_timestamp":1670002546,"8ebbeb8bfec6319a409d1d0afffa6cbf_type":"article","8ebbeb8bfec6319a409d1d0afffa6cbf_title":"30. Artificial intelligence and smart systems","8ebbeb8bfec6319a409d1d0afffa6cbf_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Technology_and_Performance_Improvements#30._Artificial_intelligence_and_smart_systems","8ebbeb8bfec6319a409d1d0afffa6cbf_plaintext":"\n\nLII:LIMSpec\/Technology and Performance ImprovementsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support core laboratory workflow, but in this case the dominant theme is additional technology that supports workflow, as well as requirements that improve overall laboratory performance.\n\n26. Instrument data systems functions \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-12-1\r\nAPHL 2019 LIS Project Management Guidebook\r\nCLSI AUTO15 2.0\n\n26.1 The system should be able to use an application programming interface or web services to communicate with instrument data systems.\r\n\n\n\nASTM E1578-18 E-12-2\r\nAPHL 2019 LIS Project Management Guidebook\r\nCLSI AUTO15 2.0\n\n26.2 The system should be capable of sending samples and test orders to instrument data systems.\n\n\n\nASTM E1578-18 E-12-3\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nCLSI AUTO15 2.0\r\n\nCLSI QMS22 2.2.2.5\r\n\nEPA ERLN Laboratory Requirements 4.9.16\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12\n\n\n26.3 The system should be capable of receiving test results from instrument data systems and verifying those results for completeness and readability.\n\n\nASTM E1578-18 E-12-4\r\nAPHL 2019 LIS Project Management Guidebook\r\nCLSI AUTO15 2.0\n\n26.4 The system should be capable of generically parsing instrument data to extract important sample details and results.\n\n\n\n27. Systems integration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 211.105 (a)\r\nASTM E1578-18 E-13-1\n\n27.1 The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems.\n\n\nASTM E1578-18 E-13-2\n\n27.2 The system should accurately communicate overall system status changes to external systems.\n\n\n\n21 CFR Part 11.10 (c)\r\n\n21 CFR Part 58.190\r\n\nABFT Accreditation Manual C-15\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 E-13-3\r\n\nEPA ERLN Laboratory Requirements 4.9.5 and 4.9.14\r\n\nISO\/IEC 17025:2017 8.4.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 3.4\r\n\nOECD GLP Principles 10\r\n\nUSDA Administrative Procedures for the PDP 5.5\r\n\nWHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1\n\n\n27.3 The system shall provide a means to choose\u2014based on date and type of data\u2014electronic data and metadata to archive.\n\n\n\n21 CFR Part 11.10 (c)\r\n\n21 CFR Part 58.51\r\n\n21 CFR Part 58.190\r\n\nABFT Accreditation Manual C-15\r\n\nASTM E1578-18 E-13-4\r\n\nCAP Laboratory Accreditation Manual\r\n\nEPA ERLN Laboratory Requirements 4.9.5\r\n\nE.U. Annex 11-17\r\n\nISO\/IEC 17025:2017 8.4.2\r\n\nOECD GLP Principles 3.4\r\n\nOECD GLP Principles 10\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\r\n\nUSDA Administrative Procedures for the PDP 5.5\r\n\nWHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1\n\n\n27.4 The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.\n\n\nASTM E1578-18 E-13-5\n\n27.5 The system should feature a reliable, effective, and supported data storage system.\n\n\n\n21 CFR Part 1.1110\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\nASTM E1578-18 C-6-6\r\n\nASTM E1578-18 E-13-6\r\n\nCLSI QMS22 2.2.3.3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\n\n\n27.6 The system should be able to interface directly with a third-party reporting tool.\n\n\nASTM E1578-18 E-13-7\n\n27.7 The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.\n\n\nASTM E1578-18 E-13-8\n\n27.8 The system should provide the ability to modify the data structures of the data storage mechanism as needed.\n\n\nASTM E1578-18 E-13-9\n\n27.9 The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.\n\n\nASTM E1578-18 E-13-10\n\n27.10 The system shall provide data storage tools capable of fine-tuning the performance and security of data.\n\n\n\n21 CFR Part 11.10 (c)\r\n\n21 CFR Part 211.68 (b)\r\n\n21 CFR Part 820.180\r\n\n45 CFR Part 164.308\r\n\nA2LA C211 4.13.1.4\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.1.4\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 E-13-11\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.4.2\r\n\nCLSI QMS22 2.8.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.6\r\n\nEPA ERLN Laboratory Requirements 4.9.5 and 4.9.14\r\n\nEPA QA\/G-5 2.1.9\r\n\nE.U. Annex 11-7.2\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 8.4.2\r\n\nNIST 800-53, Rev. 5, CP-9 and CP-10\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4)\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n27.11 The system\u2019s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure and encrypted from manipulation and loss.\n\n\nASTM E1578-18 E-13-12\n\n27.12 The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.\n\n\nASTM E1578-18 E-13-13\n\n27.13 The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.\n\n\nASTM E1578-18 E-13-14\n\n27.14 The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.\n\n\n\nASTM E1578-18 E-13-15\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nE.U. Annex 11-5\r\n\nISO 15189:2012 5.10.3\n\n\n27.15 The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing.\n\n\nASTM E1578-18 E-13-16\n\n27.16 The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.\n\n\nASTM E1578-18 E-13-17\n\n27.17 The system should be able to interface with an external enterprise resource planning system.\n\n\nASTM E1578-18 E-13-18\n\n27.18 The system should be capable of interfacing with enterprise middleware.\n\n\n\n28. Laboratory scheduling and capacity planning \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 211.25 (c)\r\nACMG Technical Standards for Clinical Genetics Laboratories B2\r\nASTM E1578-18 E-14-1\n\n28.1 The system should be able to accurately gauge and report test-based work capacity or throughput.\n\n\nASTM E1578-18 E-14-2\n\n28.2 The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.\n\n\nASTM E1578-18 E-14-3\n\n28.3 The system should provide a means for tasks to be scheduled and allocated against available resources.\n\n\n42 CFR Part 493.1274 (d)\n\n28.4 The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of cytology slides or hours worked on them.\n\n\n\n29. Lean laboratory and continuous improvement \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-15-1\n\n29.1 The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.\n\n\nASTM E1578-18 E-15-2\r\nFDA Hazard Analysis Critical Control Point Principle 1\n\n29.2 The system should provide a means to quickly visualize and assess workflow processes at strategic points.\n\n\n21 CFR Part 211.42 (b)\r\nASTM E1578-18 E-15-3\r\nFDA Hazard Analysis Critical Control Point Principle 1\n\n29.3 The system should provide a means for mapping everyday workflow while identifying potential failure points.\n\n\n\n30. Artificial intelligence and smart systems \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-16-1\n\n30.1 The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.\n\n\nASTM E1578-18 E-16-2\n\n30.2 The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.\n\n\nASTM E1578-18 E-16-3\n\n30.3 The system should support voice data capture and retrieval as smart laboratory assistance functions.\n\n\nASTM E1578-18 E-16-4\n\n30.4 The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.\n\n\nASTM E1578-18 E-16-5\r\nNIST 800-53, Rev. 5, MA-6(2)\n\n30.5 The system should support predictive maintenance routines for laboratory instruments and equipment.\n\n\nASTM E1578-18 E-16-6\n\n30.6 The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.\n\n\nASTM E1578-18 E-16-7\n\n30.7 The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.\n\n\nASTM E1578-18 E-16-8\r\nCLSI QMS22 2.1.2.1\r\nISO 15189:2012 5.10.3\r\nNIST 800-53, Rev. 5, SI-4(5) and SI-4(7)\n\n30.8 The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.\n\n\n\n7 CFR Part 331.11\r\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.11\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 211.28\r\n\n21 CFR Part 211.46\r\n\n21 CFR Part 312.58 (b)\r\n\n21 CFR Part 312.69\r\n\n42 CFR Part 73.11\r\n\n42 CFR Part 73.17\r\n\n45 CFR Part 164.310\r\n\nA2LA C211 5.3.4\r\n\nA2LA C211 5.4.7.2\r\n\nA2LA C223 5.3\r\n\nAAVLD Requirements for an AVMDL Sec. 5.3.1\u20132\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1\r\n\nASTM E1492-11 4.1.8\r\n\nASTM E1492-11 4.4.2\r\n\nASTM E1578-18 E-16-9\r\n\nCJIS Security Policy 5.9.1.6\r\n\nCLSI QMS22 2.4.2\r\n\nEPA ERLN Laboratory Requirements 4.1.13\r\n\nEPA ERLN Laboratory Requirements 4.9.6\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 6.3.3\r\n\nISO\/IEC 17025:2017 6.3.4\r\n\nISO\/TS 22002-1:2009, 18.2\r\n\nISO\/TS 22002-4:2013, 4.15\r\n\nNIST 800-53, Rev. 5, MP-2\r\n\nNIST 800-53, Rev. 5, PE-6(1)\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.2\r\n\nWHO Technical Report Series, #986, Annex 2, 9.5\r\n\nWHO Technical Report Series, #986, Annex 2, 12.8 and 12.18\n\n\n30.9 The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.\n\n\n42 CFR Part 493.1252\r\nASTM E1578-18 E-16-10\r\nISO 15189:2012 5.10.3\n\n30.10 The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.\n\n\n\n7 CFR Part 331.11\r\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.11\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 820.70 (c)\r\n\n42 CFR Part 73.11\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1252\r\n\n42 CFR Part 493.1278\r\n\nA2LA C211 5.3\r\n\nA2LA C223 5.3\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.3.1\u20132\r\n\nABFT Accreditation Manual Sec. E-22\r\n\nASTM E1578-18 E-16-11\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.3.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nISO 15189:2012 5.2.6\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 6.3.3\r\n\nISO\/IEC 17025:2017 6.3.4\r\n\nISO\/IEC 17025:2017 7.4.4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 10\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.4.5\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.5\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.4)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.2\r\n\nWADA International Standard for Laboratories (ISL) 5.3.4 and 5.3.11\r\n\nWHO Technical Report Series, #986, Annex 2, 12.8 and 12.16\n\n\n30.11 The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Technology_and_Performance_Improvements#30._Artificial_intelligence_and_smart_systems\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Technology_and_Performance_Improvements#30._Artificial_intelligence_and_smart_systems<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 20 September 2019, at 18:09.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 1,863 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","8ebbeb8bfec6319a409d1d0afffa6cbf_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Technology_and_Performance_Improvements rootpage-LII_LIMSpec_Technology_and_Performance_Improvements skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Technology and Performance Improvements<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support core laboratory workflow, but in this case the dominant theme is additional technology that supports workflow, as well as requirements that improve overall laboratory performance.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"26._Instrument_data_systems_functions\">26. Instrument data systems functions<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>26.1<\/b> The system should be able to use an application programming interface or web services to communicate with instrument data systems.<br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>26.2<\/b> The system should be capable of sending samples and test orders to instrument data systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>26.3<\/b> The system should be capable of receiving test results from instrument data systems and verifying those results for completeness and readability.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>26.4<\/b> The system should be capable of generically parsing instrument data to extract important sample details and results.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"27._Systems_integration\">27. Systems integration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.1<\/b> The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.2<\/b> The system should accurately communicate overall system status changes to external systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.3<\/b> The system shall provide a means to choose\u2014based on date and type of data\u2014electronic data and metadata to archive.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.51\" target=\"_blank\">21 CFR Part 58.51<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.4<\/b> The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.5<\/b> The system should feature a reliable, effective, and supported data storage system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.6<\/b> The system should be able to interface directly with a third-party reporting tool.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.7<\/b> The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.8<\/b> The system should provide the ability to modify the data structures of the data storage mechanism as needed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.9<\/b> The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.10<\/b> The system shall provide data storage tools capable of fine-tuning the performance and security of data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.180\" target=\"_blank\">21 CFR Part 820.180<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-9 and CP-10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.11<\/b> The system\u2019s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure and encrypted from manipulation and loss.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.12<\/b> The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-13<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.13<\/b> The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.14<\/b> The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.15<\/b> The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-16<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.16<\/b> The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-17<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.17<\/b> The system should be able to interface with an external enterprise resource planning system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-18<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.18<\/b> The system should be capable of interfacing with enterprise middleware.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"28._Laboratory_scheduling_and_capacity_planning\">28. Laboratory scheduling and capacity planning<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25 (c)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>28.1<\/b> The system should be able to accurately gauge and report test-based work capacity or throughput.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>28.2<\/b> The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>28.3<\/b> The system should provide a means for tasks to be scheduled and allocated against available resources.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>28.4<\/b> The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of cytology slides or hours worked on them.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"29._Lean_laboratory_and_continuous_improvement\">29. Lean laboratory and continuous improvement<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-15-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>29.1<\/b> The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-15-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>29.2<\/b> The system should provide a means to quickly visualize and assess workflow processes at strategic points.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.42\" target=\"_blank\">21 CFR Part 211.42 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-15-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>29.3<\/b> The system should provide a means for mapping everyday workflow while identifying potential failure points.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"30._Artificial_intelligence_and_smart_systems\">30. Artificial intelligence and smart systems<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.1<\/b> The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.2<\/b> The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.3<\/b> The system should support voice data capture and retrieval as smart laboratory assistance functions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.4<\/b> The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-6(2)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.5<\/b> The system should support predictive maintenance routines for laboratory instruments and equipment.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.6<\/b> The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.7<\/b> The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-4(5) and SI-4(7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.8<\/b> The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.28\" target=\"_blank\">21 CFR Part 211.28<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.46\" target=\"_blank\">21 CFR Part 211.46<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.69\" target=\"_blank\">21 CFR Part 312.69<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.9.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 18.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MP-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PE-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.8 and 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>30.9<\/b> The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-10<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.10<\/b> The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1278\" target=\"_blank\">42 CFR Part 493.1278<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.4 and 5.3.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.8 and 12.16<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>30.11<\/b> The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173545\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.028 seconds\nReal time usage: 0.030 seconds\nPreprocessor visited node count: 184\/1000000\nPost\u2010expand include size: 31454\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 8.117 1 -total\n 20.31% 1.649 1 Template:LIMSpec\/Instrument_data_systems_functions\n 19.61% 1.592 1 Template:LIMSpec\/Systems_integration\n 19.08% 1.549 1 Template:LIMSpec\/Artificial_intelligence_and_smart_systems\n 18.73% 1.520 1 Template:LIMSpec\/Lean_laboratory_and_continuous_improvement\n 18.20% 1.477 1 Template:LIMSpec\/Laboratory_scheduling_and_capacity_planning\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11208-0!canonical and timestamp 20221202173545 and revision id 36392. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Technology_and_Performance_Improvements#30._Artificial_intelligence_and_smart_systems\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Technology_and_Performance_Improvements#30._Artificial_intelligence_and_smart_systems<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","8ebbeb8bfec6319a409d1d0afffa6cbf_images":[],"8ebbeb8bfec6319a409d1d0afffa6cbf_timestamp":1670002546,"85b819c0b9017f33292ab934d84712b4_type":"article","85b819c0b9017f33292ab934d84712b4_title":"29. Lean laboratory and continuous improvement","85b819c0b9017f33292ab934d84712b4_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Technology_and_Performance_Improvements#29._Lean_laboratory_and_continuous_improvement","85b819c0b9017f33292ab934d84712b4_plaintext":"\n\nLII:LIMSpec\/Technology and Performance ImprovementsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support core laboratory workflow, but in this case the dominant theme is additional technology that supports workflow, as well as requirements that improve overall laboratory performance.\n\n26. Instrument data systems functions \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-12-1\r\nAPHL 2019 LIS Project Management Guidebook\r\nCLSI AUTO15 2.0\n\n26.1 The system should be able to use an application programming interface or web services to communicate with instrument data systems.\r\n\n\n\nASTM E1578-18 E-12-2\r\nAPHL 2019 LIS Project Management Guidebook\r\nCLSI AUTO15 2.0\n\n26.2 The system should be capable of sending samples and test orders to instrument data systems.\n\n\n\nASTM E1578-18 E-12-3\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nCLSI AUTO15 2.0\r\n\nCLSI QMS22 2.2.2.5\r\n\nEPA ERLN Laboratory Requirements 4.9.16\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12\n\n\n26.3 The system should be capable of receiving test results from instrument data systems and verifying those results for completeness and readability.\n\n\nASTM E1578-18 E-12-4\r\nAPHL 2019 LIS Project Management Guidebook\r\nCLSI AUTO15 2.0\n\n26.4 The system should be capable of generically parsing instrument data to extract important sample details and results.\n\n\n\n27. Systems integration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 211.105 (a)\r\nASTM E1578-18 E-13-1\n\n27.1 The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems.\n\n\nASTM E1578-18 E-13-2\n\n27.2 The system should accurately communicate overall system status changes to external systems.\n\n\n\n21 CFR Part 11.10 (c)\r\n\n21 CFR Part 58.190\r\n\nABFT Accreditation Manual C-15\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 E-13-3\r\n\nEPA ERLN Laboratory Requirements 4.9.5 and 4.9.14\r\n\nISO\/IEC 17025:2017 8.4.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 3.4\r\n\nOECD GLP Principles 10\r\n\nUSDA Administrative Procedures for the PDP 5.5\r\n\nWHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1\n\n\n27.3 The system shall provide a means to choose\u2014based on date and type of data\u2014electronic data and metadata to archive.\n\n\n\n21 CFR Part 11.10 (c)\r\n\n21 CFR Part 58.51\r\n\n21 CFR Part 58.190\r\n\nABFT Accreditation Manual C-15\r\n\nASTM E1578-18 E-13-4\r\n\nCAP Laboratory Accreditation Manual\r\n\nEPA ERLN Laboratory Requirements 4.9.5\r\n\nE.U. Annex 11-17\r\n\nISO\/IEC 17025:2017 8.4.2\r\n\nOECD GLP Principles 3.4\r\n\nOECD GLP Principles 10\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\r\n\nUSDA Administrative Procedures for the PDP 5.5\r\n\nWHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1\n\n\n27.4 The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.\n\n\nASTM E1578-18 E-13-5\n\n27.5 The system should feature a reliable, effective, and supported data storage system.\n\n\n\n21 CFR Part 1.1110\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\nASTM E1578-18 C-6-6\r\n\nASTM E1578-18 E-13-6\r\n\nCLSI QMS22 2.2.3.3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\n\n\n27.6 The system should be able to interface directly with a third-party reporting tool.\n\n\nASTM E1578-18 E-13-7\n\n27.7 The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.\n\n\nASTM E1578-18 E-13-8\n\n27.8 The system should provide the ability to modify the data structures of the data storage mechanism as needed.\n\n\nASTM E1578-18 E-13-9\n\n27.9 The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.\n\n\nASTM E1578-18 E-13-10\n\n27.10 The system shall provide data storage tools capable of fine-tuning the performance and security of data.\n\n\n\n21 CFR Part 11.10 (c)\r\n\n21 CFR Part 211.68 (b)\r\n\n21 CFR Part 820.180\r\n\n45 CFR Part 164.308\r\n\nA2LA C211 4.13.1.4\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.1.4\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 E-13-11\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.4.2\r\n\nCLSI QMS22 2.8.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.6\r\n\nEPA ERLN Laboratory Requirements 4.9.5 and 4.9.14\r\n\nEPA QA\/G-5 2.1.9\r\n\nE.U. Annex 11-7.2\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 8.4.2\r\n\nNIST 800-53, Rev. 5, CP-9 and CP-10\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4)\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n27.11 The system\u2019s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure and encrypted from manipulation and loss.\n\n\nASTM E1578-18 E-13-12\n\n27.12 The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.\n\n\nASTM E1578-18 E-13-13\n\n27.13 The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.\n\n\nASTM E1578-18 E-13-14\n\n27.14 The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.\n\n\n\nASTM E1578-18 E-13-15\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nE.U. Annex 11-5\r\n\nISO 15189:2012 5.10.3\n\n\n27.15 The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing.\n\n\nASTM E1578-18 E-13-16\n\n27.16 The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.\n\n\nASTM E1578-18 E-13-17\n\n27.17 The system should be able to interface with an external enterprise resource planning system.\n\n\nASTM E1578-18 E-13-18\n\n27.18 The system should be capable of interfacing with enterprise middleware.\n\n\n\n28. Laboratory scheduling and capacity planning \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 211.25 (c)\r\nACMG Technical Standards for Clinical Genetics Laboratories B2\r\nASTM E1578-18 E-14-1\n\n28.1 The system should be able to accurately gauge and report test-based work capacity or throughput.\n\n\nASTM E1578-18 E-14-2\n\n28.2 The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.\n\n\nASTM E1578-18 E-14-3\n\n28.3 The system should provide a means for tasks to be scheduled and allocated against available resources.\n\n\n42 CFR Part 493.1274 (d)\n\n28.4 The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of cytology slides or hours worked on them.\n\n\n\n29. Lean laboratory and continuous improvement \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-15-1\n\n29.1 The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.\n\n\nASTM E1578-18 E-15-2\r\nFDA Hazard Analysis Critical Control Point Principle 1\n\n29.2 The system should provide a means to quickly visualize and assess workflow processes at strategic points.\n\n\n21 CFR Part 211.42 (b)\r\nASTM E1578-18 E-15-3\r\nFDA Hazard Analysis Critical Control Point Principle 1\n\n29.3 The system should provide a means for mapping everyday workflow while identifying potential failure points.\n\n\n\n30. Artificial intelligence and smart systems \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-16-1\n\n30.1 The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.\n\n\nASTM E1578-18 E-16-2\n\n30.2 The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.\n\n\nASTM E1578-18 E-16-3\n\n30.3 The system should support voice data capture and retrieval as smart laboratory assistance functions.\n\n\nASTM E1578-18 E-16-4\n\n30.4 The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.\n\n\nASTM E1578-18 E-16-5\r\nNIST 800-53, Rev. 5, MA-6(2)\n\n30.5 The system should support predictive maintenance routines for laboratory instruments and equipment.\n\n\nASTM E1578-18 E-16-6\n\n30.6 The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.\n\n\nASTM E1578-18 E-16-7\n\n30.7 The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.\n\n\nASTM E1578-18 E-16-8\r\nCLSI QMS22 2.1.2.1\r\nISO 15189:2012 5.10.3\r\nNIST 800-53, Rev. 5, SI-4(5) and SI-4(7)\n\n30.8 The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.\n\n\n\n7 CFR Part 331.11\r\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.11\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 211.28\r\n\n21 CFR Part 211.46\r\n\n21 CFR Part 312.58 (b)\r\n\n21 CFR Part 312.69\r\n\n42 CFR Part 73.11\r\n\n42 CFR Part 73.17\r\n\n45 CFR Part 164.310\r\n\nA2LA C211 5.3.4\r\n\nA2LA C211 5.4.7.2\r\n\nA2LA C223 5.3\r\n\nAAVLD Requirements for an AVMDL Sec. 5.3.1\u20132\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1\r\n\nASTM E1492-11 4.1.8\r\n\nASTM E1492-11 4.4.2\r\n\nASTM E1578-18 E-16-9\r\n\nCJIS Security Policy 5.9.1.6\r\n\nCLSI QMS22 2.4.2\r\n\nEPA ERLN Laboratory Requirements 4.1.13\r\n\nEPA ERLN Laboratory Requirements 4.9.6\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 6.3.3\r\n\nISO\/IEC 17025:2017 6.3.4\r\n\nISO\/TS 22002-1:2009, 18.2\r\n\nISO\/TS 22002-4:2013, 4.15\r\n\nNIST 800-53, Rev. 5, MP-2\r\n\nNIST 800-53, Rev. 5, PE-6(1)\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.2\r\n\nWHO Technical Report Series, #986, Annex 2, 9.5\r\n\nWHO Technical Report Series, #986, Annex 2, 12.8 and 12.18\n\n\n30.9 The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.\n\n\n42 CFR Part 493.1252\r\nASTM E1578-18 E-16-10\r\nISO 15189:2012 5.10.3\n\n30.10 The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.\n\n\n\n7 CFR Part 331.11\r\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.11\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 820.70 (c)\r\n\n42 CFR Part 73.11\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1252\r\n\n42 CFR Part 493.1278\r\n\nA2LA C211 5.3\r\n\nA2LA C223 5.3\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.3.1\u20132\r\n\nABFT Accreditation Manual Sec. E-22\r\n\nASTM E1578-18 E-16-11\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.3.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nISO 15189:2012 5.2.6\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 6.3.3\r\n\nISO\/IEC 17025:2017 6.3.4\r\n\nISO\/IEC 17025:2017 7.4.4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 10\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.4.5\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.5\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.4)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.2\r\n\nWADA International Standard for Laboratories (ISL) 5.3.4 and 5.3.11\r\n\nWHO Technical Report Series, #986, Annex 2, 12.8 and 12.16\n\n\n30.11 The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Technology_and_Performance_Improvements#29._Lean_laboratory_and_continuous_improvement\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Technology_and_Performance_Improvements#29._Lean_laboratory_and_continuous_improvement<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 20 September 2019, at 18:09.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 1,863 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","85b819c0b9017f33292ab934d84712b4_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Technology_and_Performance_Improvements rootpage-LII_LIMSpec_Technology_and_Performance_Improvements skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Technology and Performance Improvements<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support core laboratory workflow, but in this case the dominant theme is additional technology that supports workflow, as well as requirements that improve overall laboratory performance.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"26._Instrument_data_systems_functions\">26. Instrument data systems functions<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>26.1<\/b> The system should be able to use an application programming interface or web services to communicate with instrument data systems.<br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>26.2<\/b> The system should be capable of sending samples and test orders to instrument data systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>26.3<\/b> The system should be capable of receiving test results from instrument data systems and verifying those results for completeness and readability.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>26.4<\/b> The system should be capable of generically parsing instrument data to extract important sample details and results.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"27._Systems_integration\">27. Systems integration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.1<\/b> The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.2<\/b> The system should accurately communicate overall system status changes to external systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.3<\/b> The system shall provide a means to choose\u2014based on date and type of data\u2014electronic data and metadata to archive.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.51\" target=\"_blank\">21 CFR Part 58.51<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.4<\/b> The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.5<\/b> The system should feature a reliable, effective, and supported data storage system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.6<\/b> The system should be able to interface directly with a third-party reporting tool.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.7<\/b> The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.8<\/b> The system should provide the ability to modify the data structures of the data storage mechanism as needed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.9<\/b> The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.10<\/b> The system shall provide data storage tools capable of fine-tuning the performance and security of data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.180\" target=\"_blank\">21 CFR Part 820.180<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-9 and CP-10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.11<\/b> The system\u2019s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure and encrypted from manipulation and loss.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.12<\/b> The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-13<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.13<\/b> The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.14<\/b> The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.15<\/b> The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-16<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.16<\/b> The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-17<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.17<\/b> The system should be able to interface with an external enterprise resource planning system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-18<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.18<\/b> The system should be capable of interfacing with enterprise middleware.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"28._Laboratory_scheduling_and_capacity_planning\">28. Laboratory scheduling and capacity planning<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25 (c)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>28.1<\/b> The system should be able to accurately gauge and report test-based work capacity or throughput.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>28.2<\/b> The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>28.3<\/b> The system should provide a means for tasks to be scheduled and allocated against available resources.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>28.4<\/b> The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of cytology slides or hours worked on them.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"29._Lean_laboratory_and_continuous_improvement\">29. Lean laboratory and continuous improvement<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-15-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>29.1<\/b> The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-15-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>29.2<\/b> The system should provide a means to quickly visualize and assess workflow processes at strategic points.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.42\" target=\"_blank\">21 CFR Part 211.42 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-15-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>29.3<\/b> The system should provide a means for mapping everyday workflow while identifying potential failure points.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"30._Artificial_intelligence_and_smart_systems\">30. Artificial intelligence and smart systems<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.1<\/b> The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.2<\/b> The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.3<\/b> The system should support voice data capture and retrieval as smart laboratory assistance functions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.4<\/b> The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-6(2)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.5<\/b> The system should support predictive maintenance routines for laboratory instruments and equipment.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.6<\/b> The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.7<\/b> The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-4(5) and SI-4(7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.8<\/b> The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.28\" target=\"_blank\">21 CFR Part 211.28<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.46\" target=\"_blank\">21 CFR Part 211.46<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.69\" target=\"_blank\">21 CFR Part 312.69<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.9.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 18.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MP-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PE-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.8 and 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>30.9<\/b> The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-10<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.10<\/b> The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1278\" target=\"_blank\">42 CFR Part 493.1278<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.4 and 5.3.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.8 and 12.16<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>30.11<\/b> The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173545\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.028 seconds\nReal time usage: 0.030 seconds\nPreprocessor visited node count: 184\/1000000\nPost\u2010expand include size: 31454\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 8.117 1 -total\n 20.31% 1.649 1 Template:LIMSpec\/Instrument_data_systems_functions\n 19.61% 1.592 1 Template:LIMSpec\/Systems_integration\n 19.08% 1.549 1 Template:LIMSpec\/Artificial_intelligence_and_smart_systems\n 18.73% 1.520 1 Template:LIMSpec\/Lean_laboratory_and_continuous_improvement\n 18.20% 1.477 1 Template:LIMSpec\/Laboratory_scheduling_and_capacity_planning\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11208-0!canonical and timestamp 20221202173545 and revision id 36392. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Technology_and_Performance_Improvements#29._Lean_laboratory_and_continuous_improvement\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Technology_and_Performance_Improvements#29._Lean_laboratory_and_continuous_improvement<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","85b819c0b9017f33292ab934d84712b4_images":[],"85b819c0b9017f33292ab934d84712b4_timestamp":1670002546,"ef63a9ea25244968b723e4ea21c2b4ec_type":"article","ef63a9ea25244968b723e4ea21c2b4ec_title":"28. Laboratory scheduling and capacity planning","ef63a9ea25244968b723e4ea21c2b4ec_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Technology_and_Performance_Improvements#28._Laboratory_scheduling_and_capacity_planning","ef63a9ea25244968b723e4ea21c2b4ec_plaintext":"\n\nLII:LIMSpec\/Technology and Performance ImprovementsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support core laboratory workflow, but in this case the dominant theme is additional technology that supports workflow, as well as requirements that improve overall laboratory performance.\n\n26. Instrument data systems functions \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-12-1\r\nAPHL 2019 LIS Project Management Guidebook\r\nCLSI AUTO15 2.0\n\n26.1 The system should be able to use an application programming interface or web services to communicate with instrument data systems.\r\n\n\n\nASTM E1578-18 E-12-2\r\nAPHL 2019 LIS Project Management Guidebook\r\nCLSI AUTO15 2.0\n\n26.2 The system should be capable of sending samples and test orders to instrument data systems.\n\n\n\nASTM E1578-18 E-12-3\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nCLSI AUTO15 2.0\r\n\nCLSI QMS22 2.2.2.5\r\n\nEPA ERLN Laboratory Requirements 4.9.16\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12\n\n\n26.3 The system should be capable of receiving test results from instrument data systems and verifying those results for completeness and readability.\n\n\nASTM E1578-18 E-12-4\r\nAPHL 2019 LIS Project Management Guidebook\r\nCLSI AUTO15 2.0\n\n26.4 The system should be capable of generically parsing instrument data to extract important sample details and results.\n\n\n\n27. Systems integration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 211.105 (a)\r\nASTM E1578-18 E-13-1\n\n27.1 The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems.\n\n\nASTM E1578-18 E-13-2\n\n27.2 The system should accurately communicate overall system status changes to external systems.\n\n\n\n21 CFR Part 11.10 (c)\r\n\n21 CFR Part 58.190\r\n\nABFT Accreditation Manual C-15\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 E-13-3\r\n\nEPA ERLN Laboratory Requirements 4.9.5 and 4.9.14\r\n\nISO\/IEC 17025:2017 8.4.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 3.4\r\n\nOECD GLP Principles 10\r\n\nUSDA Administrative Procedures for the PDP 5.5\r\n\nWHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1\n\n\n27.3 The system shall provide a means to choose\u2014based on date and type of data\u2014electronic data and metadata to archive.\n\n\n\n21 CFR Part 11.10 (c)\r\n\n21 CFR Part 58.51\r\n\n21 CFR Part 58.190\r\n\nABFT Accreditation Manual C-15\r\n\nASTM E1578-18 E-13-4\r\n\nCAP Laboratory Accreditation Manual\r\n\nEPA ERLN Laboratory Requirements 4.9.5\r\n\nE.U. Annex 11-17\r\n\nISO\/IEC 17025:2017 8.4.2\r\n\nOECD GLP Principles 3.4\r\n\nOECD GLP Principles 10\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\r\n\nUSDA Administrative Procedures for the PDP 5.5\r\n\nWHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1\n\n\n27.4 The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.\n\n\nASTM E1578-18 E-13-5\n\n27.5 The system should feature a reliable, effective, and supported data storage system.\n\n\n\n21 CFR Part 1.1110\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\nASTM E1578-18 C-6-6\r\n\nASTM E1578-18 E-13-6\r\n\nCLSI QMS22 2.2.3.3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\n\n\n27.6 The system should be able to interface directly with a third-party reporting tool.\n\n\nASTM E1578-18 E-13-7\n\n27.7 The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.\n\n\nASTM E1578-18 E-13-8\n\n27.8 The system should provide the ability to modify the data structures of the data storage mechanism as needed.\n\n\nASTM E1578-18 E-13-9\n\n27.9 The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.\n\n\nASTM E1578-18 E-13-10\n\n27.10 The system shall provide data storage tools capable of fine-tuning the performance and security of data.\n\n\n\n21 CFR Part 11.10 (c)\r\n\n21 CFR Part 211.68 (b)\r\n\n21 CFR Part 820.180\r\n\n45 CFR Part 164.308\r\n\nA2LA C211 4.13.1.4\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.1.4\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 E-13-11\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.4.2\r\n\nCLSI QMS22 2.8.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.6\r\n\nEPA ERLN Laboratory Requirements 4.9.5 and 4.9.14\r\n\nEPA QA\/G-5 2.1.9\r\n\nE.U. Annex 11-7.2\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 8.4.2\r\n\nNIST 800-53, Rev. 5, CP-9 and CP-10\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4)\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n27.11 The system\u2019s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure and encrypted from manipulation and loss.\n\n\nASTM E1578-18 E-13-12\n\n27.12 The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.\n\n\nASTM E1578-18 E-13-13\n\n27.13 The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.\n\n\nASTM E1578-18 E-13-14\n\n27.14 The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.\n\n\n\nASTM E1578-18 E-13-15\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nE.U. Annex 11-5\r\n\nISO 15189:2012 5.10.3\n\n\n27.15 The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing.\n\n\nASTM E1578-18 E-13-16\n\n27.16 The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.\n\n\nASTM E1578-18 E-13-17\n\n27.17 The system should be able to interface with an external enterprise resource planning system.\n\n\nASTM E1578-18 E-13-18\n\n27.18 The system should be capable of interfacing with enterprise middleware.\n\n\n\n28. Laboratory scheduling and capacity planning \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 211.25 (c)\r\nACMG Technical Standards for Clinical Genetics Laboratories B2\r\nASTM E1578-18 E-14-1\n\n28.1 The system should be able to accurately gauge and report test-based work capacity or throughput.\n\n\nASTM E1578-18 E-14-2\n\n28.2 The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.\n\n\nASTM E1578-18 E-14-3\n\n28.3 The system should provide a means for tasks to be scheduled and allocated against available resources.\n\n\n42 CFR Part 493.1274 (d)\n\n28.4 The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of cytology slides or hours worked on them.\n\n\n\n29. Lean laboratory and continuous improvement \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-15-1\n\n29.1 The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.\n\n\nASTM E1578-18 E-15-2\r\nFDA Hazard Analysis Critical Control Point Principle 1\n\n29.2 The system should provide a means to quickly visualize and assess workflow processes at strategic points.\n\n\n21 CFR Part 211.42 (b)\r\nASTM E1578-18 E-15-3\r\nFDA Hazard Analysis Critical Control Point Principle 1\n\n29.3 The system should provide a means for mapping everyday workflow while identifying potential failure points.\n\n\n\n30. Artificial intelligence and smart systems \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-16-1\n\n30.1 The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.\n\n\nASTM E1578-18 E-16-2\n\n30.2 The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.\n\n\nASTM E1578-18 E-16-3\n\n30.3 The system should support voice data capture and retrieval as smart laboratory assistance functions.\n\n\nASTM E1578-18 E-16-4\n\n30.4 The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.\n\n\nASTM E1578-18 E-16-5\r\nNIST 800-53, Rev. 5, MA-6(2)\n\n30.5 The system should support predictive maintenance routines for laboratory instruments and equipment.\n\n\nASTM E1578-18 E-16-6\n\n30.6 The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.\n\n\nASTM E1578-18 E-16-7\n\n30.7 The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.\n\n\nASTM E1578-18 E-16-8\r\nCLSI QMS22 2.1.2.1\r\nISO 15189:2012 5.10.3\r\nNIST 800-53, Rev. 5, SI-4(5) and SI-4(7)\n\n30.8 The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.\n\n\n\n7 CFR Part 331.11\r\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.11\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 211.28\r\n\n21 CFR Part 211.46\r\n\n21 CFR Part 312.58 (b)\r\n\n21 CFR Part 312.69\r\n\n42 CFR Part 73.11\r\n\n42 CFR Part 73.17\r\n\n45 CFR Part 164.310\r\n\nA2LA C211 5.3.4\r\n\nA2LA C211 5.4.7.2\r\n\nA2LA C223 5.3\r\n\nAAVLD Requirements for an AVMDL Sec. 5.3.1\u20132\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1\r\n\nASTM E1492-11 4.1.8\r\n\nASTM E1492-11 4.4.2\r\n\nASTM E1578-18 E-16-9\r\n\nCJIS Security Policy 5.9.1.6\r\n\nCLSI QMS22 2.4.2\r\n\nEPA ERLN Laboratory Requirements 4.1.13\r\n\nEPA ERLN Laboratory Requirements 4.9.6\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 6.3.3\r\n\nISO\/IEC 17025:2017 6.3.4\r\n\nISO\/TS 22002-1:2009, 18.2\r\n\nISO\/TS 22002-4:2013, 4.15\r\n\nNIST 800-53, Rev. 5, MP-2\r\n\nNIST 800-53, Rev. 5, PE-6(1)\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.2\r\n\nWHO Technical Report Series, #986, Annex 2, 9.5\r\n\nWHO Technical Report Series, #986, Annex 2, 12.8 and 12.18\n\n\n30.9 The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.\n\n\n42 CFR Part 493.1252\r\nASTM E1578-18 E-16-10\r\nISO 15189:2012 5.10.3\n\n30.10 The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.\n\n\n\n7 CFR Part 331.11\r\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.11\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 820.70 (c)\r\n\n42 CFR Part 73.11\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1252\r\n\n42 CFR Part 493.1278\r\n\nA2LA C211 5.3\r\n\nA2LA C223 5.3\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.3.1\u20132\r\n\nABFT Accreditation Manual Sec. E-22\r\n\nASTM E1578-18 E-16-11\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.3.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nISO 15189:2012 5.2.6\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 6.3.3\r\n\nISO\/IEC 17025:2017 6.3.4\r\n\nISO\/IEC 17025:2017 7.4.4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 10\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.4.5\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.5\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.4)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.2\r\n\nWADA International Standard for Laboratories (ISL) 5.3.4 and 5.3.11\r\n\nWHO Technical Report Series, #986, Annex 2, 12.8 and 12.16\n\n\n30.11 The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Technology_and_Performance_Improvements#28._Laboratory_scheduling_and_capacity_planning\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Technology_and_Performance_Improvements#28._Laboratory_scheduling_and_capacity_planning<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 20 September 2019, at 18:09.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 1,863 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","ef63a9ea25244968b723e4ea21c2b4ec_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Technology_and_Performance_Improvements rootpage-LII_LIMSpec_Technology_and_Performance_Improvements skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Technology and Performance Improvements<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support core laboratory workflow, but in this case the dominant theme is additional technology that supports workflow, as well as requirements that improve overall laboratory performance.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"26._Instrument_data_systems_functions\">26. Instrument data systems functions<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>26.1<\/b> The system should be able to use an application programming interface or web services to communicate with instrument data systems.<br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>26.2<\/b> The system should be capable of sending samples and test orders to instrument data systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>26.3<\/b> The system should be capable of receiving test results from instrument data systems and verifying those results for completeness and readability.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>26.4<\/b> The system should be capable of generically parsing instrument data to extract important sample details and results.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"27._Systems_integration\">27. Systems integration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.1<\/b> The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.2<\/b> The system should accurately communicate overall system status changes to external systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.3<\/b> The system shall provide a means to choose\u2014based on date and type of data\u2014electronic data and metadata to archive.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.51\" target=\"_blank\">21 CFR Part 58.51<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.4<\/b> The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.5<\/b> The system should feature a reliable, effective, and supported data storage system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.6<\/b> The system should be able to interface directly with a third-party reporting tool.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.7<\/b> The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.8<\/b> The system should provide the ability to modify the data structures of the data storage mechanism as needed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.9<\/b> The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.10<\/b> The system shall provide data storage tools capable of fine-tuning the performance and security of data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.180\" target=\"_blank\">21 CFR Part 820.180<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-9 and CP-10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.11<\/b> The system\u2019s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure and encrypted from manipulation and loss.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.12<\/b> The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-13<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.13<\/b> The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.14<\/b> The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.15<\/b> The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-16<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.16<\/b> The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-17<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.17<\/b> The system should be able to interface with an external enterprise resource planning system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-18<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.18<\/b> The system should be capable of interfacing with enterprise middleware.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"28._Laboratory_scheduling_and_capacity_planning\">28. Laboratory scheduling and capacity planning<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25 (c)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>28.1<\/b> The system should be able to accurately gauge and report test-based work capacity or throughput.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>28.2<\/b> The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>28.3<\/b> The system should provide a means for tasks to be scheduled and allocated against available resources.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>28.4<\/b> The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of cytology slides or hours worked on them.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"29._Lean_laboratory_and_continuous_improvement\">29. Lean laboratory and continuous improvement<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-15-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>29.1<\/b> The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-15-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>29.2<\/b> The system should provide a means to quickly visualize and assess workflow processes at strategic points.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.42\" target=\"_blank\">21 CFR Part 211.42 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-15-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>29.3<\/b> The system should provide a means for mapping everyday workflow while identifying potential failure points.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"30._Artificial_intelligence_and_smart_systems\">30. Artificial intelligence and smart systems<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.1<\/b> The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.2<\/b> The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.3<\/b> The system should support voice data capture and retrieval as smart laboratory assistance functions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.4<\/b> The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-6(2)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.5<\/b> The system should support predictive maintenance routines for laboratory instruments and equipment.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.6<\/b> The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.7<\/b> The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-4(5) and SI-4(7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.8<\/b> The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.28\" target=\"_blank\">21 CFR Part 211.28<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.46\" target=\"_blank\">21 CFR Part 211.46<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.69\" target=\"_blank\">21 CFR Part 312.69<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.9.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 18.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MP-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PE-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.8 and 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>30.9<\/b> The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-10<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.10<\/b> The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1278\" target=\"_blank\">42 CFR Part 493.1278<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.4 and 5.3.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.8 and 12.16<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>30.11<\/b> The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173545\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.028 seconds\nReal time usage: 0.030 seconds\nPreprocessor visited node count: 184\/1000000\nPost\u2010expand include size: 31454\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 8.117 1 -total\n 20.31% 1.649 1 Template:LIMSpec\/Instrument_data_systems_functions\n 19.61% 1.592 1 Template:LIMSpec\/Systems_integration\n 19.08% 1.549 1 Template:LIMSpec\/Artificial_intelligence_and_smart_systems\n 18.73% 1.520 1 Template:LIMSpec\/Lean_laboratory_and_continuous_improvement\n 18.20% 1.477 1 Template:LIMSpec\/Laboratory_scheduling_and_capacity_planning\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11208-0!canonical and timestamp 20221202173545 and revision id 36392. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Technology_and_Performance_Improvements#28._Laboratory_scheduling_and_capacity_planning\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Technology_and_Performance_Improvements#28._Laboratory_scheduling_and_capacity_planning<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","ef63a9ea25244968b723e4ea21c2b4ec_images":[],"ef63a9ea25244968b723e4ea21c2b4ec_timestamp":1670002546,"16790a3329a8f9a6998e3a9a5c30ec80_type":"article","16790a3329a8f9a6998e3a9a5c30ec80_title":"27. Systems integration","16790a3329a8f9a6998e3a9a5c30ec80_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Technology_and_Performance_Improvements#27._Systems_integration","16790a3329a8f9a6998e3a9a5c30ec80_plaintext":"\n\nLII:LIMSpec\/Technology and Performance ImprovementsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support core laboratory workflow, but in this case the dominant theme is additional technology that supports workflow, as well as requirements that improve overall laboratory performance.\n\n26. Instrument data systems functions \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-12-1\r\nAPHL 2019 LIS Project Management Guidebook\r\nCLSI AUTO15 2.0\n\n26.1 The system should be able to use an application programming interface or web services to communicate with instrument data systems.\r\n\n\n\nASTM E1578-18 E-12-2\r\nAPHL 2019 LIS Project Management Guidebook\r\nCLSI AUTO15 2.0\n\n26.2 The system should be capable of sending samples and test orders to instrument data systems.\n\n\n\nASTM E1578-18 E-12-3\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nCLSI AUTO15 2.0\r\n\nCLSI QMS22 2.2.2.5\r\n\nEPA ERLN Laboratory Requirements 4.9.16\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12\n\n\n26.3 The system should be capable of receiving test results from instrument data systems and verifying those results for completeness and readability.\n\n\nASTM E1578-18 E-12-4\r\nAPHL 2019 LIS Project Management Guidebook\r\nCLSI AUTO15 2.0\n\n26.4 The system should be capable of generically parsing instrument data to extract important sample details and results.\n\n\n\n27. Systems integration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 211.105 (a)\r\nASTM E1578-18 E-13-1\n\n27.1 The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems.\n\n\nASTM E1578-18 E-13-2\n\n27.2 The system should accurately communicate overall system status changes to external systems.\n\n\n\n21 CFR Part 11.10 (c)\r\n\n21 CFR Part 58.190\r\n\nABFT Accreditation Manual C-15\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 E-13-3\r\n\nEPA ERLN Laboratory Requirements 4.9.5 and 4.9.14\r\n\nISO\/IEC 17025:2017 8.4.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 3.4\r\n\nOECD GLP Principles 10\r\n\nUSDA Administrative Procedures for the PDP 5.5\r\n\nWHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1\n\n\n27.3 The system shall provide a means to choose\u2014based on date and type of data\u2014electronic data and metadata to archive.\n\n\n\n21 CFR Part 11.10 (c)\r\n\n21 CFR Part 58.51\r\n\n21 CFR Part 58.190\r\n\nABFT Accreditation Manual C-15\r\n\nASTM E1578-18 E-13-4\r\n\nCAP Laboratory Accreditation Manual\r\n\nEPA ERLN Laboratory Requirements 4.9.5\r\n\nE.U. Annex 11-17\r\n\nISO\/IEC 17025:2017 8.4.2\r\n\nOECD GLP Principles 3.4\r\n\nOECD GLP Principles 10\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\r\n\nUSDA Administrative Procedures for the PDP 5.5\r\n\nWHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1\n\n\n27.4 The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.\n\n\nASTM E1578-18 E-13-5\n\n27.5 The system should feature a reliable, effective, and supported data storage system.\n\n\n\n21 CFR Part 1.1110\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\nASTM E1578-18 C-6-6\r\n\nASTM E1578-18 E-13-6\r\n\nCLSI QMS22 2.2.3.3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\n\n\n27.6 The system should be able to interface directly with a third-party reporting tool.\n\n\nASTM E1578-18 E-13-7\n\n27.7 The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.\n\n\nASTM E1578-18 E-13-8\n\n27.8 The system should provide the ability to modify the data structures of the data storage mechanism as needed.\n\n\nASTM E1578-18 E-13-9\n\n27.9 The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.\n\n\nASTM E1578-18 E-13-10\n\n27.10 The system shall provide data storage tools capable of fine-tuning the performance and security of data.\n\n\n\n21 CFR Part 11.10 (c)\r\n\n21 CFR Part 211.68 (b)\r\n\n21 CFR Part 820.180\r\n\n45 CFR Part 164.308\r\n\nA2LA C211 4.13.1.4\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.1.4\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 E-13-11\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.4.2\r\n\nCLSI QMS22 2.8.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.6\r\n\nEPA ERLN Laboratory Requirements 4.9.5 and 4.9.14\r\n\nEPA QA\/G-5 2.1.9\r\n\nE.U. Annex 11-7.2\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 8.4.2\r\n\nNIST 800-53, Rev. 5, CP-9 and CP-10\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4)\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n27.11 The system\u2019s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure and encrypted from manipulation and loss.\n\n\nASTM E1578-18 E-13-12\n\n27.12 The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.\n\n\nASTM E1578-18 E-13-13\n\n27.13 The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.\n\n\nASTM E1578-18 E-13-14\n\n27.14 The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.\n\n\n\nASTM E1578-18 E-13-15\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nE.U. Annex 11-5\r\n\nISO 15189:2012 5.10.3\n\n\n27.15 The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing.\n\n\nASTM E1578-18 E-13-16\n\n27.16 The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.\n\n\nASTM E1578-18 E-13-17\n\n27.17 The system should be able to interface with an external enterprise resource planning system.\n\n\nASTM E1578-18 E-13-18\n\n27.18 The system should be capable of interfacing with enterprise middleware.\n\n\n\n28. Laboratory scheduling and capacity planning \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 211.25 (c)\r\nACMG Technical Standards for Clinical Genetics Laboratories B2\r\nASTM E1578-18 E-14-1\n\n28.1 The system should be able to accurately gauge and report test-based work capacity or throughput.\n\n\nASTM E1578-18 E-14-2\n\n28.2 The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.\n\n\nASTM E1578-18 E-14-3\n\n28.3 The system should provide a means for tasks to be scheduled and allocated against available resources.\n\n\n42 CFR Part 493.1274 (d)\n\n28.4 The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of cytology slides or hours worked on them.\n\n\n\n29. Lean laboratory and continuous improvement \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-15-1\n\n29.1 The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.\n\n\nASTM E1578-18 E-15-2\r\nFDA Hazard Analysis Critical Control Point Principle 1\n\n29.2 The system should provide a means to quickly visualize and assess workflow processes at strategic points.\n\n\n21 CFR Part 211.42 (b)\r\nASTM E1578-18 E-15-3\r\nFDA Hazard Analysis Critical Control Point Principle 1\n\n29.3 The system should provide a means for mapping everyday workflow while identifying potential failure points.\n\n\n\n30. Artificial intelligence and smart systems \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-16-1\n\n30.1 The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.\n\n\nASTM E1578-18 E-16-2\n\n30.2 The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.\n\n\nASTM E1578-18 E-16-3\n\n30.3 The system should support voice data capture and retrieval as smart laboratory assistance functions.\n\n\nASTM E1578-18 E-16-4\n\n30.4 The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.\n\n\nASTM E1578-18 E-16-5\r\nNIST 800-53, Rev. 5, MA-6(2)\n\n30.5 The system should support predictive maintenance routines for laboratory instruments and equipment.\n\n\nASTM E1578-18 E-16-6\n\n30.6 The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.\n\n\nASTM E1578-18 E-16-7\n\n30.7 The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.\n\n\nASTM E1578-18 E-16-8\r\nCLSI QMS22 2.1.2.1\r\nISO 15189:2012 5.10.3\r\nNIST 800-53, Rev. 5, SI-4(5) and SI-4(7)\n\n30.8 The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.\n\n\n\n7 CFR Part 331.11\r\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.11\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 211.28\r\n\n21 CFR Part 211.46\r\n\n21 CFR Part 312.58 (b)\r\n\n21 CFR Part 312.69\r\n\n42 CFR Part 73.11\r\n\n42 CFR Part 73.17\r\n\n45 CFR Part 164.310\r\n\nA2LA C211 5.3.4\r\n\nA2LA C211 5.4.7.2\r\n\nA2LA C223 5.3\r\n\nAAVLD Requirements for an AVMDL Sec. 5.3.1\u20132\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1\r\n\nASTM E1492-11 4.1.8\r\n\nASTM E1492-11 4.4.2\r\n\nASTM E1578-18 E-16-9\r\n\nCJIS Security Policy 5.9.1.6\r\n\nCLSI QMS22 2.4.2\r\n\nEPA ERLN Laboratory Requirements 4.1.13\r\n\nEPA ERLN Laboratory Requirements 4.9.6\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 6.3.3\r\n\nISO\/IEC 17025:2017 6.3.4\r\n\nISO\/TS 22002-1:2009, 18.2\r\n\nISO\/TS 22002-4:2013, 4.15\r\n\nNIST 800-53, Rev. 5, MP-2\r\n\nNIST 800-53, Rev. 5, PE-6(1)\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.2\r\n\nWHO Technical Report Series, #986, Annex 2, 9.5\r\n\nWHO Technical Report Series, #986, Annex 2, 12.8 and 12.18\n\n\n30.9 The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.\n\n\n42 CFR Part 493.1252\r\nASTM E1578-18 E-16-10\r\nISO 15189:2012 5.10.3\n\n30.10 The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.\n\n\n\n7 CFR Part 331.11\r\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.11\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 820.70 (c)\r\n\n42 CFR Part 73.11\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1252\r\n\n42 CFR Part 493.1278\r\n\nA2LA C211 5.3\r\n\nA2LA C223 5.3\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.3.1\u20132\r\n\nABFT Accreditation Manual Sec. E-22\r\n\nASTM E1578-18 E-16-11\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.3.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nISO 15189:2012 5.2.6\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 6.3.3\r\n\nISO\/IEC 17025:2017 6.3.4\r\n\nISO\/IEC 17025:2017 7.4.4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 10\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.4.5\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.5\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.4)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.2\r\n\nWADA International Standard for Laboratories (ISL) 5.3.4 and 5.3.11\r\n\nWHO Technical Report Series, #986, Annex 2, 12.8 and 12.16\n\n\n30.11 The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Technology_and_Performance_Improvements#27._Systems_integration\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Technology_and_Performance_Improvements#27._Systems_integration<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 20 September 2019, at 18:09.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 1,863 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","16790a3329a8f9a6998e3a9a5c30ec80_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Technology_and_Performance_Improvements rootpage-LII_LIMSpec_Technology_and_Performance_Improvements skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Technology and Performance Improvements<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support core laboratory workflow, but in this case the dominant theme is additional technology that supports workflow, as well as requirements that improve overall laboratory performance.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"26._Instrument_data_systems_functions\">26. Instrument data systems functions<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>26.1<\/b> The system should be able to use an application programming interface or web services to communicate with instrument data systems.<br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>26.2<\/b> The system should be capable of sending samples and test orders to instrument data systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>26.3<\/b> The system should be capable of receiving test results from instrument data systems and verifying those results for completeness and readability.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>26.4<\/b> The system should be capable of generically parsing instrument data to extract important sample details and results.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"27._Systems_integration\">27. Systems integration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.1<\/b> The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.2<\/b> The system should accurately communicate overall system status changes to external systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.3<\/b> The system shall provide a means to choose\u2014based on date and type of data\u2014electronic data and metadata to archive.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.51\" target=\"_blank\">21 CFR Part 58.51<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.4<\/b> The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.5<\/b> The system should feature a reliable, effective, and supported data storage system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.6<\/b> The system should be able to interface directly with a third-party reporting tool.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.7<\/b> The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.8<\/b> The system should provide the ability to modify the data structures of the data storage mechanism as needed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.9<\/b> The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.10<\/b> The system shall provide data storage tools capable of fine-tuning the performance and security of data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.180\" target=\"_blank\">21 CFR Part 820.180<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-9 and CP-10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.11<\/b> The system\u2019s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure and encrypted from manipulation and loss.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.12<\/b> The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-13<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.13<\/b> The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.14<\/b> The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.15<\/b> The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-16<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.16<\/b> The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-17<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.17<\/b> The system should be able to interface with an external enterprise resource planning system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-18<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.18<\/b> The system should be capable of interfacing with enterprise middleware.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"28._Laboratory_scheduling_and_capacity_planning\">28. Laboratory scheduling and capacity planning<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25 (c)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>28.1<\/b> The system should be able to accurately gauge and report test-based work capacity or throughput.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>28.2<\/b> The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>28.3<\/b> The system should provide a means for tasks to be scheduled and allocated against available resources.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>28.4<\/b> The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of cytology slides or hours worked on them.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"29._Lean_laboratory_and_continuous_improvement\">29. Lean laboratory and continuous improvement<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-15-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>29.1<\/b> The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-15-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>29.2<\/b> The system should provide a means to quickly visualize and assess workflow processes at strategic points.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.42\" target=\"_blank\">21 CFR Part 211.42 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-15-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>29.3<\/b> The system should provide a means for mapping everyday workflow while identifying potential failure points.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"30._Artificial_intelligence_and_smart_systems\">30. Artificial intelligence and smart systems<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.1<\/b> The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.2<\/b> The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.3<\/b> The system should support voice data capture and retrieval as smart laboratory assistance functions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.4<\/b> The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-6(2)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.5<\/b> The system should support predictive maintenance routines for laboratory instruments and equipment.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.6<\/b> The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.7<\/b> The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-4(5) and SI-4(7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.8<\/b> The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.28\" target=\"_blank\">21 CFR Part 211.28<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.46\" target=\"_blank\">21 CFR Part 211.46<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.69\" target=\"_blank\">21 CFR Part 312.69<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.9.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 18.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MP-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PE-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.8 and 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>30.9<\/b> The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-10<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.10<\/b> The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1278\" target=\"_blank\">42 CFR Part 493.1278<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.4 and 5.3.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.8 and 12.16<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>30.11<\/b> The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173545\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.028 seconds\nReal time usage: 0.030 seconds\nPreprocessor visited node count: 184\/1000000\nPost\u2010expand include size: 31454\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 8.117 1 -total\n 20.31% 1.649 1 Template:LIMSpec\/Instrument_data_systems_functions\n 19.61% 1.592 1 Template:LIMSpec\/Systems_integration\n 19.08% 1.549 1 Template:LIMSpec\/Artificial_intelligence_and_smart_systems\n 18.73% 1.520 1 Template:LIMSpec\/Lean_laboratory_and_continuous_improvement\n 18.20% 1.477 1 Template:LIMSpec\/Laboratory_scheduling_and_capacity_planning\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11208-0!canonical and timestamp 20221202173545 and revision id 36392. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Technology_and_Performance_Improvements#27._Systems_integration\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Technology_and_Performance_Improvements#27._Systems_integration<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","16790a3329a8f9a6998e3a9a5c30ec80_images":[],"16790a3329a8f9a6998e3a9a5c30ec80_timestamp":1670002545,"6b7bf1eb07b0c58eaa599ed5a69c9298_type":"article","6b7bf1eb07b0c58eaa599ed5a69c9298_title":"26. Instrument data systems functions","6b7bf1eb07b0c58eaa599ed5a69c9298_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Technology_and_Performance_Improvements#26._Instrument_data_systems_functions","6b7bf1eb07b0c58eaa599ed5a69c9298_plaintext":"\n\nLII:LIMSpec\/Technology and Performance ImprovementsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support core laboratory workflow, but in this case the dominant theme is additional technology that supports workflow, as well as requirements that improve overall laboratory performance.\n\n26. Instrument data systems functions \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-12-1\r\nAPHL 2019 LIS Project Management Guidebook\r\nCLSI AUTO15 2.0\n\n26.1 The system should be able to use an application programming interface or web services to communicate with instrument data systems.\r\n\n\n\nASTM E1578-18 E-12-2\r\nAPHL 2019 LIS Project Management Guidebook\r\nCLSI AUTO15 2.0\n\n26.2 The system should be capable of sending samples and test orders to instrument data systems.\n\n\n\nASTM E1578-18 E-12-3\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nCLSI AUTO15 2.0\r\n\nCLSI QMS22 2.2.2.5\r\n\nEPA ERLN Laboratory Requirements 4.9.16\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12\n\n\n26.3 The system should be capable of receiving test results from instrument data systems and verifying those results for completeness and readability.\n\n\nASTM E1578-18 E-12-4\r\nAPHL 2019 LIS Project Management Guidebook\r\nCLSI AUTO15 2.0\n\n26.4 The system should be capable of generically parsing instrument data to extract important sample details and results.\n\n\n\n27. Systems integration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 211.105 (a)\r\nASTM E1578-18 E-13-1\n\n27.1 The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems.\n\n\nASTM E1578-18 E-13-2\n\n27.2 The system should accurately communicate overall system status changes to external systems.\n\n\n\n21 CFR Part 11.10 (c)\r\n\n21 CFR Part 58.190\r\n\nABFT Accreditation Manual C-15\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 E-13-3\r\n\nEPA ERLN Laboratory Requirements 4.9.5 and 4.9.14\r\n\nISO\/IEC 17025:2017 8.4.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 3.4\r\n\nOECD GLP Principles 10\r\n\nUSDA Administrative Procedures for the PDP 5.5\r\n\nWHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1\n\n\n27.3 The system shall provide a means to choose\u2014based on date and type of data\u2014electronic data and metadata to archive.\n\n\n\n21 CFR Part 11.10 (c)\r\n\n21 CFR Part 58.51\r\n\n21 CFR Part 58.190\r\n\nABFT Accreditation Manual C-15\r\n\nASTM E1578-18 E-13-4\r\n\nCAP Laboratory Accreditation Manual\r\n\nEPA ERLN Laboratory Requirements 4.9.5\r\n\nE.U. Annex 11-17\r\n\nISO\/IEC 17025:2017 8.4.2\r\n\nOECD GLP Principles 3.4\r\n\nOECD GLP Principles 10\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\r\n\nUSDA Administrative Procedures for the PDP 5.5\r\n\nWHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1\n\n\n27.4 The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.\n\n\nASTM E1578-18 E-13-5\n\n27.5 The system should feature a reliable, effective, and supported data storage system.\n\n\n\n21 CFR Part 1.1110\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\nASTM E1578-18 C-6-6\r\n\nASTM E1578-18 E-13-6\r\n\nCLSI QMS22 2.2.3.3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\n\n\n27.6 The system should be able to interface directly with a third-party reporting tool.\n\n\nASTM E1578-18 E-13-7\n\n27.7 The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.\n\n\nASTM E1578-18 E-13-8\n\n27.8 The system should provide the ability to modify the data structures of the data storage mechanism as needed.\n\n\nASTM E1578-18 E-13-9\n\n27.9 The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.\n\n\nASTM E1578-18 E-13-10\n\n27.10 The system shall provide data storage tools capable of fine-tuning the performance and security of data.\n\n\n\n21 CFR Part 11.10 (c)\r\n\n21 CFR Part 211.68 (b)\r\n\n21 CFR Part 820.180\r\n\n45 CFR Part 164.308\r\n\nA2LA C211 4.13.1.4\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.1.4\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 E-13-11\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.4.2\r\n\nCLSI QMS22 2.8.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.6\r\n\nEPA ERLN Laboratory Requirements 4.9.5 and 4.9.14\r\n\nEPA QA\/G-5 2.1.9\r\n\nE.U. Annex 11-7.2\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 8.4.2\r\n\nNIST 800-53, Rev. 5, CP-9 and CP-10\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4)\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n27.11 The system\u2019s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure and encrypted from manipulation and loss.\n\n\nASTM E1578-18 E-13-12\n\n27.12 The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.\n\n\nASTM E1578-18 E-13-13\n\n27.13 The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.\n\n\nASTM E1578-18 E-13-14\n\n27.14 The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.\n\n\n\nASTM E1578-18 E-13-15\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nE.U. Annex 11-5\r\n\nISO 15189:2012 5.10.3\n\n\n27.15 The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing.\n\n\nASTM E1578-18 E-13-16\n\n27.16 The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.\n\n\nASTM E1578-18 E-13-17\n\n27.17 The system should be able to interface with an external enterprise resource planning system.\n\n\nASTM E1578-18 E-13-18\n\n27.18 The system should be capable of interfacing with enterprise middleware.\n\n\n\n28. Laboratory scheduling and capacity planning \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 211.25 (c)\r\nACMG Technical Standards for Clinical Genetics Laboratories B2\r\nASTM E1578-18 E-14-1\n\n28.1 The system should be able to accurately gauge and report test-based work capacity or throughput.\n\n\nASTM E1578-18 E-14-2\n\n28.2 The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.\n\n\nASTM E1578-18 E-14-3\n\n28.3 The system should provide a means for tasks to be scheduled and allocated against available resources.\n\n\n42 CFR Part 493.1274 (d)\n\n28.4 The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of cytology slides or hours worked on them.\n\n\n\n29. Lean laboratory and continuous improvement \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-15-1\n\n29.1 The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.\n\n\nASTM E1578-18 E-15-2\r\nFDA Hazard Analysis Critical Control Point Principle 1\n\n29.2 The system should provide a means to quickly visualize and assess workflow processes at strategic points.\n\n\n21 CFR Part 211.42 (b)\r\nASTM E1578-18 E-15-3\r\nFDA Hazard Analysis Critical Control Point Principle 1\n\n29.3 The system should provide a means for mapping everyday workflow while identifying potential failure points.\n\n\n\n30. Artificial intelligence and smart systems \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-16-1\n\n30.1 The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.\n\n\nASTM E1578-18 E-16-2\n\n30.2 The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.\n\n\nASTM E1578-18 E-16-3\n\n30.3 The system should support voice data capture and retrieval as smart laboratory assistance functions.\n\n\nASTM E1578-18 E-16-4\n\n30.4 The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.\n\n\nASTM E1578-18 E-16-5\r\nNIST 800-53, Rev. 5, MA-6(2)\n\n30.5 The system should support predictive maintenance routines for laboratory instruments and equipment.\n\n\nASTM E1578-18 E-16-6\n\n30.6 The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.\n\n\nASTM E1578-18 E-16-7\n\n30.7 The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.\n\n\nASTM E1578-18 E-16-8\r\nCLSI QMS22 2.1.2.1\r\nISO 15189:2012 5.10.3\r\nNIST 800-53, Rev. 5, SI-4(5) and SI-4(7)\n\n30.8 The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.\n\n\n\n7 CFR Part 331.11\r\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.11\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 211.28\r\n\n21 CFR Part 211.46\r\n\n21 CFR Part 312.58 (b)\r\n\n21 CFR Part 312.69\r\n\n42 CFR Part 73.11\r\n\n42 CFR Part 73.17\r\n\n45 CFR Part 164.310\r\n\nA2LA C211 5.3.4\r\n\nA2LA C211 5.4.7.2\r\n\nA2LA C223 5.3\r\n\nAAVLD Requirements for an AVMDL Sec. 5.3.1\u20132\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1\r\n\nASTM E1492-11 4.1.8\r\n\nASTM E1492-11 4.4.2\r\n\nASTM E1578-18 E-16-9\r\n\nCJIS Security Policy 5.9.1.6\r\n\nCLSI QMS22 2.4.2\r\n\nEPA ERLN Laboratory Requirements 4.1.13\r\n\nEPA ERLN Laboratory Requirements 4.9.6\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 6.3.3\r\n\nISO\/IEC 17025:2017 6.3.4\r\n\nISO\/TS 22002-1:2009, 18.2\r\n\nISO\/TS 22002-4:2013, 4.15\r\n\nNIST 800-53, Rev. 5, MP-2\r\n\nNIST 800-53, Rev. 5, PE-6(1)\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.2\r\n\nWHO Technical Report Series, #986, Annex 2, 9.5\r\n\nWHO Technical Report Series, #986, Annex 2, 12.8 and 12.18\n\n\n30.9 The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.\n\n\n42 CFR Part 493.1252\r\nASTM E1578-18 E-16-10\r\nISO 15189:2012 5.10.3\n\n30.10 The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.\n\n\n\n7 CFR Part 331.11\r\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.11\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 820.70 (c)\r\n\n42 CFR Part 73.11\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1252\r\n\n42 CFR Part 493.1278\r\n\nA2LA C211 5.3\r\n\nA2LA C223 5.3\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.3.1\u20132\r\n\nABFT Accreditation Manual Sec. E-22\r\n\nASTM E1578-18 E-16-11\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.3.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nISO 15189:2012 5.2.6\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 6.3.3\r\n\nISO\/IEC 17025:2017 6.3.4\r\n\nISO\/IEC 17025:2017 7.4.4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 10\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.4.5\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.5\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.4)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.2\r\n\nWADA International Standard for Laboratories (ISL) 5.3.4 and 5.3.11\r\n\nWHO Technical Report Series, #986, Annex 2, 12.8 and 12.16\n\n\n30.11 The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Technology_and_Performance_Improvements#26._Instrument_data_systems_functions\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Technology_and_Performance_Improvements#26._Instrument_data_systems_functions<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 20 September 2019, at 18:09.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 1,863 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","6b7bf1eb07b0c58eaa599ed5a69c9298_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Technology_and_Performance_Improvements rootpage-LII_LIMSpec_Technology_and_Performance_Improvements skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Technology and Performance Improvements<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support core laboratory workflow, but in this case the dominant theme is additional technology that supports workflow, as well as requirements that improve overall laboratory performance.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"26._Instrument_data_systems_functions\">26. Instrument data systems functions<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>26.1<\/b> The system should be able to use an application programming interface or web services to communicate with instrument data systems.<br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>26.2<\/b> The system should be capable of sending samples and test orders to instrument data systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>26.3<\/b> The system should be capable of receiving test results from instrument data systems and verifying those results for completeness and readability.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>26.4<\/b> The system should be capable of generically parsing instrument data to extract important sample details and results.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"27._Systems_integration\">27. Systems integration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.1<\/b> The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.2<\/b> The system should accurately communicate overall system status changes to external systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.3<\/b> The system shall provide a means to choose\u2014based on date and type of data\u2014electronic data and metadata to archive.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.51\" target=\"_blank\">21 CFR Part 58.51<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.4<\/b> The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.5<\/b> The system should feature a reliable, effective, and supported data storage system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.6<\/b> The system should be able to interface directly with a third-party reporting tool.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.7<\/b> The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.8<\/b> The system should provide the ability to modify the data structures of the data storage mechanism as needed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.9<\/b> The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.10<\/b> The system shall provide data storage tools capable of fine-tuning the performance and security of data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.180\" target=\"_blank\">21 CFR Part 820.180<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-9 and CP-10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.11<\/b> The system\u2019s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure and encrypted from manipulation and loss.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.12<\/b> The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-13<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.13<\/b> The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.14<\/b> The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.15<\/b> The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-16<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.16<\/b> The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-17<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.17<\/b> The system should be able to interface with an external enterprise resource planning system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-18<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.18<\/b> The system should be capable of interfacing with enterprise middleware.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"28._Laboratory_scheduling_and_capacity_planning\">28. Laboratory scheduling and capacity planning<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25 (c)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>28.1<\/b> The system should be able to accurately gauge and report test-based work capacity or throughput.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>28.2<\/b> The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>28.3<\/b> The system should provide a means for tasks to be scheduled and allocated against available resources.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>28.4<\/b> The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of cytology slides or hours worked on them.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"29._Lean_laboratory_and_continuous_improvement\">29. Lean laboratory and continuous improvement<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-15-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>29.1<\/b> The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-15-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>29.2<\/b> The system should provide a means to quickly visualize and assess workflow processes at strategic points.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.42\" target=\"_blank\">21 CFR Part 211.42 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-15-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>29.3<\/b> The system should provide a means for mapping everyday workflow while identifying potential failure points.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"30._Artificial_intelligence_and_smart_systems\">30. Artificial intelligence and smart systems<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.1<\/b> The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.2<\/b> The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.3<\/b> The system should support voice data capture and retrieval as smart laboratory assistance functions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.4<\/b> The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-6(2)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.5<\/b> The system should support predictive maintenance routines for laboratory instruments and equipment.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.6<\/b> The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.7<\/b> The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-4(5) and SI-4(7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.8<\/b> The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.28\" target=\"_blank\">21 CFR Part 211.28<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.46\" target=\"_blank\">21 CFR Part 211.46<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.69\" target=\"_blank\">21 CFR Part 312.69<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.9.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 18.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MP-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PE-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.8 and 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>30.9<\/b> The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-10<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.10<\/b> The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1278\" target=\"_blank\">42 CFR Part 493.1278<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.4 and 5.3.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.8 and 12.16<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>30.11<\/b> The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173545\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.028 seconds\nReal time usage: 0.030 seconds\nPreprocessor visited node count: 184\/1000000\nPost\u2010expand include size: 31454\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 8.117 1 -total\n 20.31% 1.649 1 Template:LIMSpec\/Instrument_data_systems_functions\n 19.61% 1.592 1 Template:LIMSpec\/Systems_integration\n 19.08% 1.549 1 Template:LIMSpec\/Artificial_intelligence_and_smart_systems\n 18.73% 1.520 1 Template:LIMSpec\/Lean_laboratory_and_continuous_improvement\n 18.20% 1.477 1 Template:LIMSpec\/Laboratory_scheduling_and_capacity_planning\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11208-0!canonical and timestamp 20221202173545 and revision id 36392. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Technology_and_Performance_Improvements#26._Instrument_data_systems_functions\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Technology_and_Performance_Improvements#26._Instrument_data_systems_functions<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","6b7bf1eb07b0c58eaa599ed5a69c9298_images":[],"6b7bf1eb07b0c58eaa599ed5a69c9298_timestamp":1670002545,"94577196babcc5bb87b20331aa12d805_type":"article","94577196babcc5bb87b20331aa12d805_title":"25. Health information technology","94577196babcc5bb87b20331aa12d805_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#25._Health_information_technology","94577196babcc5bb87b20331aa12d805_plaintext":"\n\nLII:LIMSpec\/Specialty Laboratory FunctionsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover the specialty requirements that come with working in specific industries such as agriculture, pharmaceutical production, and forensic science. You'll likely notice that most of the content here isn't covered by ASTM E1578-18.\n\n17. Production management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 211.103\r\n21 CFR Part 226.40 (d)\r\nWHO Technical Report Series, #986, Annex 2, 16.4 and 16.20\n\n17.1 The system should be able to calculate and record theoretical and actual percentage of yield at various phases of processing, manufacturing, and packaging.\n\n\n21 CFR Part 211.103\n\n17.2 The system should provide a means for verification and approval of yield calculations before release for reporting.\n\n\n\n21 CFR Part 820.20\r\n\n21 CFR Part 820.40\r\n\n21 CFR Part 820.186\r\n\nE.U. Commission Directive 2003\/94\/EC Article 11\r\n\nWHO Technical Report Series, #986, Annex 2, 1.0\n\n\n17.3 The system shall be able to maintain a production facility's quality system in a specific quality system record, in accordance with regulations and guidance such as 21 CFR Part 820.20 and 820.40 (U.S.), E.U. Commission Directive 2003\/94\/EC Article 11 (E.U.), and WHO Technical Report Series, #986, Annex 2, 1.0 (global).\n\n\n21 CFR Part 820.30\r\n21 CFR Part 820.120 (e)\n\n17.4 The system shall be able to create a design control document capable of recording the details surrounding device development, including control number, physical and performance requirements, final output, review, verification, approval, transfer, changes, and complete design history.\n\n\n21 CFR Part 820.181\r\n21 CFR Part 820.184\n\n17.5 The system shall be able to create a device master and device history record capable of recording all information described in 21 CFR Part 820.181 and 820.184.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 111.255\u2013260\r\n\n21 CFR Part 114.100 (b)\r\n\n21 CFR Part 211.105 (b)\r\n\n21 CFR Part 211.130 (e)\r\n\n21 CFR Part 211.134 (c)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.20 (d)\r\n\n21 CFR Part 211.50 (c)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 225.202\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 820.60\r\n\n21 CFR Part 820.70 (a)\r\n\n21 CFR Part 820.80 (c)\r\n\n21 CFR Part 820.120 (d)\r\n\nBRC GSFS, Issue 8, 6.1.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.1.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 8.1\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.1\r\n\nFDA Hazard Analysis Critical Control Point Principle 2 and 4\r\n\nFDA Hazard Analysis Critical Control Point Principle 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11\r\n\nIFS Food 7, Part 2, 4.2.1.1\r\n\nIFS Food 7, Part 2, 4.18.1\r\n\nIFS PACsecure 2, Part 2, 4.2.1.1\r\n\nIFS PACsecure 2, Part 2, 4.18.1\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (3)\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f\u2013g)\r\n\nWHO Technical Report Series, #986, Annex 2, 15.25\u201330\n\n\n17.6 The system shall be able to create a batch production record capable of recording complete information regarding batch production and control details such as, but not limited to, a unique batch, lot, or production run number; formulation; specific labeling and packaging; production steps; in-process and laboratory control results; the unique identifier of any equipment used; persons performing and\/or supervising operational steps; and the results of any pre-process or post-production inspections.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.100 (e)\r\n\n21 CFR Part 111.205\u2013210\r\n\n21 CFR Part 114.100 (b)\r\n\n21 CFR Part 211.186\r\n\n21 CFR Part 212.50 (b)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nBRC GSFS, Issue 8, 3.6.2\r\n\nBRC GSFS, Issue 8, 9.2.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.1.2\r\n\nFDA Hazard Analysis Critical Control Point Principle 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11\r\n\nIFS Food 7, Part 2, 4.2.1.1\r\n\nIFS PACsecure 2, Part 2, 4.2.1.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 15.22\u201323\n\n\n17.7 The system shall be able to create a master production and control record capable of recording complete information regarding master production and control details.\n\n\n\n21 CFR Part 106.100 (e)\r\n\n21 CFR Part 111.123 (a)\r\n\n21 CFR Part 114.100 (c)\r\n\n21 CFR Part 117.150 (d)\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.186\r\n\n21 CFR Part 212.50 (b)\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nBRC GSFS, Issue 8, 9.2.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 10.3\u20134\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.2\r\n\nIFS Food 7, Part 2, 4.2.1.2\r\n\nIFS Food 7, Part 2, 4.3.x\r\n\nIFS Food 7, Part 2, 5.11\r\n\nIFS PACsecure 2, Part 2, 4.2.1.2\r\n\nIFS PACsecure 2, Part 2, 4.3.x\r\n\nIFS PACsecure 2, Part 2, 5.11\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b)\r\n\nWHO Technical Report Series, #986, Annex 2, 4.0\n\n\n17.8 The system shall require a new or modified master production and control record to be validated, reviewed, and approved before being implemented into production, including allowing that record to be electronically signed by one or more authorized individuals upon approval. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n\n\n\n21 CFR Part 111.123 (a)\r\n\n21 CFR Part 114.100 (c)\r\n\n21 CFR Part 117.150 (d)\r\n\n21 CFR Part 211.22\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 820.70 (b)\r\n\n21 CFR Part 820.75\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 10.3\r\n\nIFS Food 7, Part 2, 4.2.1.2\r\n\nIFS Food 7, Part 2, 4.3.x\r\n\nIFS Food 7, Part 2, 5.11\r\n\nIFS PACsecure 2, Part 2, 4.2.1.2\r\n\nIFS PACsecure 2, Part 2, 4.3.x\r\n\nIFS PACsecure 2, Part 2, 5.11\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b, f)\r\n\nWHO Technical Report Series, #986, Annex 2, 4.0\n\n\n17.9 The system shall require a new or modified production and control record to be validated, reviewed, and approved before being implemented in production. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n\n\n\n21 CFR Part 211.110\r\n\n21 CFR Part 212.50\r\n\n21 CFR Part 820.80 (c)\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\r\n\nISO\/TS 22002-1:2009, 14.3\n\n\n17.10 The system shall be able to indicate if a sample consists of an in-process manufacturing material and track characteristics of the in-process material such as identity, strength, quality, purity, and approval status.\n\n\n21 CFR Part 211.111\n\n17.11 The system shall provide a means to track the amount of time between production processes.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.80\r\n\n21 CFR Part 106.100 (f-6)\r\n\n21 CFR Part 117.420\r\n\n21 CFR Part 211.122 (c)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 212.20 (b)\r\n\n21 CFR Part 212.40 (c) and (e)\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.40 (b)\r\n\n21 CFR Part 226.42\r\n\n21 CFR Part 606.120 (b)\r\n\n21 CFR Part 820.60\r\n\n21 CFR Part 820.80 (b)\r\n\n21 CFR Part 820.120 (b)\r\n\nBRC GSFS, Issue 8, 3.6.1\r\n\nBRC GSFS, Issue 8, 3.9.2\r\n\nBRC GSFS, Issue 8, 5.4.4\r\n\nBRC GSFS, Issue 8, 3.5.1\r\n\nBRC GSFS, Issue 8, 9.5.1\u20132\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17\r\n\nIFS Food 7, Part 2, 4.5.2\r\n\nIFS Food 7, Part 2, 4.18.1\r\n\nIFS PACsecure 2, Part 2, 4.5.2\r\n\nIFS PACsecure 2, Part 2, 4.18.1\r\n\nISO\/TS 22002-1:2009, 9.3\r\n\nISO\/TS 22002-1:2009, 14.2\r\n\nISO\/TS 22002-4:2013, 4.6.3\r\n\nISO\/TS 22002-4:2013, 4.11.2\r\n\nISO\/TS 22002-6:2016, 4.6.3\r\n\nISO\/TS 22002-6:2016, 4.11.2\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nWHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21\r\n\nWHO Technical Report Series, #986, Annex 2, 15.32\u201333\n\n\n17.12 The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, certificates of conformity, shelf life or expiration date, storage location, status of examination, and status of approval for use. Any related specifications for those materials should be able to be linked to the received materials.\n\n\n\n21 CFR Part 211.122 (e)\r\n\n21 CFR Part 211.125 (d)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.42\r\n\nBRC GSFS, Issue 8, 3.5.3\r\n\nBRC GSFS, Issue 8, 9.5.3\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17\r\n\nWHO Technical Report Series, #986, Annex 2, 14.7 and 14.22\r\n\nWHO Technical Report Series, #986, Annex 2, 16.35\n\n\n17.13 The system shall be capable of recording the changing quantity of inventoried non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, labeling, containers, and packaging materials), including batch and lot numbers and, if applicable, details of disposition after completion of production.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.70\r\n\n21 CFR Part 111.113\r\n\n21 CFR Part 111.123 (b)\r\n\n21 CFR Part 114.100 (d)\r\n\n21 CFR Part 120.10\r\n\n21 CFR Part 123.6\r\n\n21 CFR Part 211.122 (e)\r\n\n21 CFR Part 211.125 (d)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.42\r\n\n21 CFR Part 606.100 (c)\r\n\n21 CFR Part 820.80 (d\u2013e)\r\n\n21 CFR Part 820.90\r\n\n21 CFR Part 820.160\r\n\nBRC GSFS, Issue 8, 3.8.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.2\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 23\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\nIFS Food 7, Part 2, 5.7.1\r\n\nIFS Food 7, Part 2, 5.10\r\n\nIFS PACsecure 2, Part 2, 5.7.1\r\n\nIFS PACsecure 2, Part 2, 5.10\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.5\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.7\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.5\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.7\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.5\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.7\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (g)\r\n\nWHO Technical Report Series, #986, Annex 2, 14.4, 14.26, and 14.28\r\n\nWHO Technical Report Series, #986, Annex 2, 15.44\u201345\r\n\nWHO Technical Report Series, #986, Annex 2, 16.36\r\n\nWHO Technical Report Series, #986, Annex 2, 17.18\u201319\n\n\n17.14 The system shall prevent the internal release for distribution of a completed production batch until an authorized individual has determined the batch's conformance to final specifications and has approved it for release. If a batch is nonconforming, the system shall be able to clearly document it as such (so as to not distribute it) and provide a review and disposition process. Such approval, rejection, review, and disposition activities shall be documented.\n\n\n\n21 CFR Part 7 Subpart C\r\n\n21 CFR Part 117.139\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 507.38\r\n\n21 CFR Part 810 Subpart B\r\n\nBRC GSFS, Issue 8, 3.11.2\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.5\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\nIFS Food 7, Part 2, 5.9.2\r\n\nIFS PACsecure 2, Part 2, 5.9.2\r\n\nISO\/TS 22002-1:2009, 15.x\r\n\nISO\/TS 22002-4:2013, 4.12\r\n\nISO\/TS 22002-6:2016, 4.12\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.6.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.6.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.3\r\n\nWHO Technical Report Series, #986, Annex 2, 6.0\r\n\nWHO Technical Report Series, #986, Annex 2, 14.32\n\n\n17.15 The system shall provide a means to track and record recall activities of manufactured product and devices based on lot, batch, or other identifier, including storage location, necessary disposition details, and reconciliation between distributed and recovered quantities.\n\n\n\n21 CFR Part 111.520\r\n\n21 CFR Part 211.165 (f)\r\n\n21 CFR Part 211.204\r\n\n21 CFR Part 212.71 (d)\r\n\n21 CFR Part 820.90 (b-2)\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.6\r\n\nWHO Technical Report Series, #986, Annex 2, 14.29\u201330\n\n\n17.16 The system should allow a completed production batch that has been rejected for use or a returned production batch to be flagged in the system for reprocessing or reworking if it meets relevant criteria.\n\n\n\n21 CFR Part 112.145\r\n\nBRC GSFS, Issue 8, 4.11.8.x\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, I - FSM 19.2\r\n\nISO\/TS 22002-1:2009, 11.5\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.8\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.8\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.8\n\n\n17.17 The system shall support environmental testing protocols for testing the production environment on a scheduled, reportable basis. That support shall include facility and sampling site management functionality that allows for highlighting specific test points in the facility, as well as support for offsite and randomized testing. The system should also allow associated samples, methods, tests, reports, and other documents to clearly indicate they correspond to specific environmental testing protocols.\n\n\n\n18. Statistical trending and control charts \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 820.250\r\n\nAIHA-LAP Policies 2018 2A.7.7.1.3\r\n\nASTM E1578-18 E-10-1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7.2.8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.8\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 9\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\n\n\n18.1 The system should allow authorized users to configure the generation of statistical trending and control charts.\n\n\n\n21 CFR Part 820.250\r\n\nAIHA-LAP Policies 2018 2A.7.7.1.3\r\n\nASTM E1578-18 E-10-2\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7.2.8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.8\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 9\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\n\n\n18.2 The system should allow authorized users to choose specific sample types, tests, and parameters associated with the statistical trending and control charts that can be generated.\n\n\n\n19. Agriculture and food data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nFDA Office of Regulatory Affairs Data Exchange (ORA DX) Program\n\n19.1 The system should be able to create or convert an XML or XLS file to ORA DX template specifications, including the use of ORA DX terminology.\n\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\nUSDA Sampling Procedures for PDP 5.3\r\nUSDA Sampling Procedures for PDP 6.2\n\n19.2 The system shall allow for the assignment of the \"regulatory sample collection\" role and be able to produce a list of individuals in said role, including information such as name, locations assigned, part- or full-time role, and full-time equivalents (if any) used to meet any regulatory requirements.\n\n\nUSDA Sampling Procedures for PDP 5.4\n\n19.3 The system shall allow for the documentation of sampling sites used for normal and regulatory sampling and be able to produce a complete list of such sites on-demand. The documentation should allow for details such as the addition of a unique, never-before-used site code; a region code; demographics; date added to or removed from the system; facility type; sample substrates or commodities available at the site; and relative volume information.\n\n\nUSDA Sampling Procedures for PDP 5.4.12 and 5.4.14\n\n19.4 The system shall allow a site that is no longer active for sampling purposes be designated as inactive, yet be allowed to remain on any generated master list. Additionally, such inactive site shall maintain its unique site number in the event the site becomes reinstated as active.\n\n\n\n21 CFR Part 117.130\u2013135\r\n\n21 CFR Part 120 (throughout)\r\n\n21 CFR Part 123.6\r\n\n21 CFR Part 507, Subpart C\r\n\n61 FR 38806, 9 CFR Part 417.x\r\n\nBRC GSFS, Issue 8, 2.x\r\n\nCodex Alimentarius CXC 1-1969, Ch.2, 3.x\r\n\nE.U. Commission Reg. No. 852\/2004 Article 5\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - HACCP 1.X\r\n\nIFS Food 7, Part 2, 2.2.x\r\n\nIFS PACsecure 2, Part 2, 2.2.x\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.3\n\n\n19.5 The system shall allow for the development and documentation of hazard analysis and critical control points (HACCP) or other regulatory-driven food safety plan steps, as well as the implementation of those CCPs or steps into configurable laboratory workflow.\n\n\n61 FR 38806, 9 CFR Part 417.4\n\n19.6 The system shall require a new or modified HACCP or other regulatory-driven food safety plan be validated, reviewed, and approved before being implemented, including requiring that plan to be electronically signed by one or more authorized individuals upon approval.\n\n\n\n21 CFR Part 106.90\r\n\n21 CFR Part 106.92\r\n\n21 CFR Part 106.94\r\n\n21 CFR Part 106.100 (j)\r\n\nBRC GSFS, Issue 8, 3.4.x\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 20\r\n\nIFS Food 7, Part 2, 5.1\r\n\nIFS PACsecure 2, Part 2, 5.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.4\n\n\n19.7 The system shall allow for the documentation and management of internal and external audit activities, while allowing samples, methods, tests, results, reports, documents, and more to be clearly associated with that corresponding audit activity.\n\n\n\n20. Environmental data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nEPA Metadata Technical Specification\n\n20.1 The system should support metadata requirements set forth by ISO 19115 and the EPA Metadata Technical Specification for reporting and data publishing purposes.\n\n\nEPA ERLN Laboratory Requirements 3.3\n\n20.2 The system should support the manual entry or electronic transfer of EPA analytical service requests (ASRs), along with all the required fields of the ASR, including project identifier, project demographics, sample specifics, sample hazards, reporting requirements, and special requirements.\n\n\nEPA SEDD Specification and Data Element Dictionary v5.2\n\n20.3 The system should support the creation and transfer of Staged Electronic Data Deliverable (SEDD) files.\n\n\n\n40 CFR Part 3.10\r\n\n40 CFR Part 60 (throughout)\r\n\n40 CFR Part 62 (throughout)\r\n\n40 CFR Part 63 (throughout)\n\n\n20.4 The system shall support generating electronic environmental reports (e.g., stationary source emissions tests) in either the EPA's Electronic Reporting Tool (ERT) special spreadsheet format or in an XML file format that complies with EPA-approved XML schema.\n\n\nDoD General Data Validation Guidelines\n\n20.5 The system should support electronic data deliverable (EDD) validation by linking the EDD to its quality assurance project plan (QAPP) and the appropriate stage of validation for the EDD's data type.\n\n\n\n21. Forensic case and data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.4.3\nASTM E1188-11 3.2.3\r\n\nASTM E1188-11 3.4.1\r\n\nASTM E1459-13 2.1\r\n\nASTM E1459-13 4.1.1\u20132\r\n\nASTM E1459-13 4.1.4.2\r\n\nASTM E1459-13 4.2.2\u20133\r\n\nASTM E1492-11 4.1.1\r\n\nASTM E1492-11 4.1.5\n\n\n21.1 The system shall be able to assign each piece of collected evidence and each scene a unique identifier using methodologies such as an ID with an incrementing integer (for sequential evidence numbers) or a user-defined naming format for meeting regulatory requirements.\n\n\nA2LA C223 4.13\r\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.6\u201310\r\nASTM E1492-11 4.1.1\r\n\n\n21.2 The system shall be able to assign each case a unique case identifier that, in addition to an electronic signature, is able to be automatically placed on, at a maximum, each page of the case's associated examination and administration records.\n\n\n\nA2LA C223 4.13\r\n\nASTM E1492-11 4.1.1.1\u20132\r\n\nASTM E1492-11 4.1.4\u20135\r\n\nASTM E1492-11 4.2.2\u20133\r\n\nASTM E1492-11 4.5.1.1\n\n\n21.3 In addition to a unique case number, the system shall provide a means to add additional information to a case file, including, but not limited to, submitting agency, agency case number, date of case receipt, name of recipient, shipping and receipt details, items associated with the case and their unique designators, notes, test data, related reports, and other documentation.\n\n\nASTM E1188-11 (throughout)\r\nASTM E1459-13 (throughout)\r\nASTM E1492-11 4.4.3 and 4.5.1\n\n21.4 The system should be able to document evidence using an ASTM-compliant evidence log, including, but not limited to, unique identifiers, investigator and custodian names, key dates and times, evidence conditions, and storage location.\n\n\nASTM E1492-11 4.3.1.1\n\n21.5 The system should be able to prevent a piece of evidence from being scheduled for destructive testing until an appropriate authorization for such analysis is acquired and documented.\n\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1.1\r\nASTM E1492-11 4.1.2\n\n21.6 The system shall be able to record and maintain chain of custody of evidence that is subdivided in the laboratory in the same way that original evidence items are tracked.\n\n\nCJIS Security Policy 5.1.3\n\n21.7 The system shall be capable of recording the secondary dissemination to an authorized agency or organization of criminal history record information (CHRI) sourced from U.S. Criminal Justice Information Services (CJIS).\n\n\nCJIS Security Policy 5.4.7\n\n21.8 The system shall be able to record all National Crime Information Center (NCIC) and Interstate Identification Index (III) data transactions, clearly identifying the operator and authorized receiving agency or organization. III records shall also identify requester and recipient using a unique identifier.\n\n\nCJIS Security Policy 5.5.6\r\nNIST 800-53, Rev. 5, AC-17(1) \r\n\n\n21.9 If the system provides remote access to authorized users over authorized devices, the remote access shall be monitored, controlled and documented, particularly for privileged functions. If remote access to privileged functions is allowed, virtual escorting that meets CJIS Security Policy 5.5.6 conditions will be required.\n\n\nCJIS Security Policy 5.6.2.1.1.1\u20132\r\nCJIS Security Policy 5.6.2.1.2\u20133\r\nNIST 800-53, Rev. 5, IA-5(1) \r\n\n\n21.10 The system shall be capable of putting into place, in their entirety, either the \"basic password standards\" or \"advanced password standards\" described in CJIS Security Policy 5.6.2.1.1.1 and 5.6.2.1.1.2. If PIN and\/or one-time password is also used, the attributes in 5.6.2.1.2 and 5.6.2.1.3 shall also be required.\n\n\nCJIS Security Policy 5.6.2.2\n\n21.11 If the system supports user-based certificates for authentication, the system shall be configurable enough to require them to be 1. user-specific, not device-specific, 2. used only by one user at any given time, and 3. activated for each use by, e.g., a passphrase or PIN.\n\n\nCJIS Security Policy 5.10.1.2.1\u20132\r\n\nCJIS Security Policy Appendix G.6\r\n\nNIST 800-53, Rev. 5, AC-17(2) \r\n\nNIST 800-53, Rev. 5, SC-13, SC-28, and SC-28(1)\r\n\n\n\n21.12 The system shall allow \"encryption in transit\" and \"encryption at rest\" of criminal justice information (CJI) that meets or exceeds the requirements of CJIS Security Policy 5.10.1.2.1 and 5.10.1.2.2.\n\n\nCJIS Security Policy 5.10.1.5\n\n21.13 If the system is cloud-based, the vendor shall ensure that CJI is stored in databases located within the physical boundaries of APB-member countries and within the legal authority of APB-member agencies. Additionally, the vendor shall agree to not use any metadata derived from unencrypted CJI for commercial, advertising, or other purposes, unless specifically permitted for limited within the service agreement.\n\n\nCJIS Security Policy 5.11.1\u20132\n\n21.14 If the system is cloud-based, the vendor should agree to FBI and CSA compliance and security audits of CJI.\n\n\nCJIS Security Policy 5.10.3.2\r\nCJIS Security Policy Appendix G.1\n\n21.15 If the system is capable of being run in a virtual environment, it shall meet the virtualization requirements set forth in CJIS Security Policy 5.10.3.2 and best practices set forth in CJIS Security Policy Appendix G.1.\n\n\nCJIS Security Policy Appendix G.5\r\nNIST 800-53, Rev. 5, AC-6(4)\r\n\nNIST 800-53, Rev. 5, SC-39\r\n\n\n\n21.16 The system should provide separate processing domains in order to not only allow for more granular allocation of user privileges, but also to prevent one process from modifying the executing code of another process.\n\n\nNIST 800-53, Rev. 5, IA-2(1\u20132), IA-2(12), and IA-8(1)\n\n21.17 The system should support the use of personal identity verification\u2014a U.S. Federal government-wide credential system\u2014and other forms of hardware-based (i.e., public key infrastructure or PKI) token authentication, while electronically verifying those credentials and any configured token quality requirements.\n\n\nA2LA C223 5.4\n\n21.18 The system should support the identification and tagging of infrequently performed forensic tests or analyses in order to alert the analyst and other stakeholders that additional competency verification or method validation is required before performing the test or analysis.\n\n\nA2LA C223 5.9\n\n21.19 The system should allow case records to be scheduled for periodic administrative and technical review by individuals not connected with the case. The conducted review should indicate details such as who conducted the review, what the results were, and when the review was completed. If non-conforming results were discovered, records of determination and resolution should be appended to the case record.\n\n\nA2LA C223 5.9\n\n21.20 The system should be able to document examiner testimony and allow such testimony to be scheduled for periodic evaluation. The conducted evaluation should indicate details such as who conducted the evaluation, what the results were, and when the review was completed. If non-conforming results were discovered, related records of determination and resolution should be maintained in the system.\n\n\n\n22. Clinical and public health data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nCDC PHIN Messaging System\n\n22.1 The system should be capable of interfacing with the Center for Disease Control and Prevention's PHIN Messaging System.\n\n\nACMG Technical Standards for Clinical Genetics Laboratories G1.5\r\n\n\n22.2 The system should support Human Genome Variation Society (HGVS) nomenclature and terminology for sequence variants.\n\n\nCLSI QMS22 2.1.2.3\n\n22.3 The system should be able to collect sufficient test utilization information to make necessity checks on ordered tests against established benchmarks.\n\n\nONC USCDI v2\n\n22.4 The system should support the United States Core Data for Interoperability (USCDI) v2 standard, which in turn supports data interoperability across multiple clinical settings.\n\n\n\n23. Veterinary data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nNAHLN Information Technology System\r\nVeNom Coding Group\r\nVeterinary Terminology Services Laboratory\n\n23.1 The system should support standardized veterinary clinical terminology such as that found in the Veterinary Extension of SNOMED CT and the Veterinary Nomenclature (VeNom) Codes.\n\n\nICAR 15 Data Exchange\r\nVICH GL53\n\n23.2 The system should be able to exchange data, when necessary, in a fashion that meets International Committee for Animal Recording (ICAR) and Veterinary International Conference on Harmonization (VICH) electronic data exchange guidelines.\n\n\nNAHLN HL7 Messaging Quick User Guide\n\n23.3 The system should support National Animal Health Laboratory Network (NAHLN), and, by extension, Health Level 7 (HL7) result messaging.\n\n\n\n24. Scientific data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASTM E1578-18 E-11-1\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.1 The system shall capture raw instrument data and metadata either as an electronic file or directly via RS-232 or TCP\/IP communication.\n\n\nASTM E1578-18 E-11-2\n\n24.2 The scientific data management system (SDMS) should provide a checksum verification of source and destination data and store that verification data in a secure server with controlled access.\n\n\n\nASTM E1578-18 E-11-1\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.3 The system shall store metadata related to raw instrument data in a database in such a way that the original data generated by instruments for specific samples and tests is easy to retrieve.\n\n\nASTM E1578-18 E-11-4\n\n24.4 The system should be capable of capturing a complete and readable copy of original data and any previous versions of modified data in order to maintain the integrity of that data.\n\n\n\nAAVLD AAVLD Requirements for an AVMDL Sec. 4.10.2.3\r\n\nASTM E1578-18 E-11-5\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.5 The system should secure raw data such that it can't be deleted and provide version control when data is modified by any user or specific software.\n\n\nASTM E1578-18 E-11-6\n\n24.6 The SDMS should provide tools for helping a laboratory achieve the U.S. Food and Drug Administration's defined ALCOA principles.\n\n\nASTM E1578-18 E-11-7\n\n24.7 The SDMS shall provide security and access controls for protecting stored data.\n\n\nASTM E1578-18 E-11-8\n\n24.8 The SDMS shall record an audit trail for each and every record created and modified, using version control.\n\n\n45 CFR Part 164.308\r\nASTM E1578-18 E-11-9\n\n24.9 The SDMS shall provide proper systems for backing up, restoring, and archiving data for long-term use.\n\n\n\n25. Health information technology \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n45 CFR Part 170.315 (a-1\u2013a-4)\n\n25.1 The electronic health record (EHR) module should provide computerized provider order entry (CPOE) functionality for medication orders, laboratory orders, and diagnostic imaging, including making checks for potential drug-drug and drug-allergy interactions.\n\n\n45 CFR Part 170.315 (a-5)\r\n45 CFR Part 170.315 (a-11\u2013a-12)\r\n45 CFR Part 170.315 (a-15)\n\n25.2 The EHR module should allow authorized personnel to record, change, and access patient demographic data, including, but not limited to, race and ethnicity, patient's preferred language, birth sex, current sex, sexual orientation, gender identity, birth date, smoking status, alcohol use, family health history, psychological aspects, social aspects, and behavioral aspects.\n\n\n45 CFR Part 170.315 (a-6\u2013a-8)\r\n45 CFR Part 170.315 (a-10)\r\n45 CFR Part 170.315 (a-14)\n\n25.3 The EHR module should allow authorized personnel to record, change, and access a patient's active problem list, medication list, medication allergy list, preferred drug list, and implantable device list, incorporating, where appropriate, at a minimum the SNOMED CT nomenclature standard.\n\n\n45 CFR Part 170.315 (a-19)\n\n25.4 The EHR module should incorporate configurable, role-based clinical decision support tools capable of allowing authorized personnel to trigger electronic interventions based on liked reference information standardized to Health Level 7 (HL7) Version 3 implementation guides. The reference information should be sourced.\n\n\n45 CFR Part 170.315 (a-13)\n\n25.5 The EHR module should be able to identify education resources specific to a patient's active problem and medication lists. The educational resources should be standardized to Health Level 7 (HL7) Version 3 implementation guides.\n\n\n45 CFR Part 170.315 (b-1\u2013b-2; b-4\u2013b-5)\n\n25.6 The EHR module should allow authorized personnel to create, view, send, and receive transition of care or referral summaries in such a way that the summary is properly formatted, matched to the correct patient, and reconciled according to the standards and protocols outlined in 45 CFR Part 170.315 (b-1), (b-2), (b-4), and (b-5).\n\n\n45 CFR Part 170.315 (b-3)\n\n25.7 The EHR module should allow authorized personnel to conduct electronic prescribing actions such as creating, changing, cancelling, and refilling prescriptions, incorporating at least the RxNorm and NCPDP SCRIPT standards.\n\n\n45 CFR Part 170.315 (b-6)\n\n25.8 The EHR module should allow authorized personnel to configure, create, and store data exports, incorporating at least HL7 Version 3 implementation standards, as well as SNOMED CT and ICD-9 standards.\n\n\n45 CFR Part 170.315 (b-7\u2013b-8)\n\n25.9 The EHR module should allow for the secure creation, sending, and receipt of restricted summary records, incorporating HL7 Version 3 implementation standards.\n\n\n45 CFR Part 170.315 (b-9)\n\n25.10 The EHR module should allow authorized personnel to create, record, change, access, and receive care plan information, incorporating HL7 Version 3 implementation standards.\n\n\n45 CFR Part 170.315 (c)\n\n25.11 The EHR module should provide a means to record, calculate, import, export, filter, and report on clinical quality measures according to the standards outlined in 45 CFR Part 170.315 (c).\n\n\n45 CFR Part 170.315 (d)\n\n25.12 The EHR module shall provide security and access controls for protecting stored data.\n\n\n45 CFR Part 170.315 (d)\n\n25.13 The EHR module shall record an audit trail for each and every record created and modified, using version control.\n\n\n45 CFR Part 170.315 (d-7)\n\n25.14 The EHR module shall either encrypt electronic health information on end-user devices after use of the technology on the device stops or prevent electronic health information from being stored on end-user devices after use of the technology on the device stops.\n\n\n45 CFR Part 170.315 (d-8)\n\n25.15 The EHR module shall ensure that electronically exchanged health information has not been altered during the transfer process, using at least a hashing algorithm secured to SHA-2 or better.\n\n\n45 CFR Part 170.315 (d-11)\n\n25.16 The EHR module should be capable of recording patient disclosures made for treatment, payment, and health care operations.\n\n\n45 CFR Part 170.315 (e-1)\n\n25.17 The EHR module should provide a means for patients and their authorized representatives to view, download, and transmit their personal health information and activity history log from the EHR via an internet-based technology, using the standards outlined in 45 CFR Part 170.315 (e-1).\n\n\n45 CFR Part 170.315 (e-2\u2013e-3)\n\n25.18 The EHR module should provide a means for authorized users to securely send messages to and receive messages from patients, at the same time allowing for the recording, accessing, and linking of information shared by the patient electronically (as well as directly).\n\n\n45 CFR Part 170.315 (f)\n\n25.19 The EHR module should allow vital patient information as it relates to public health to be transmitted to immunization registries, cancer registries, and public health agencies, as well as be accessed after the fact. This includes, but is not limited to, immunization history, surveillance information, laboratory test results, cancer case information, case reports, antimicrobial reporting, and health care survey information.\n\n\n45 CFR Part 170.315 (g-3\u2013g-5)\n\n25.20 The EHR developer should use user-centered and accessibility-centered design processes for creating and testing the EHR's functionality. A quality management system should be used during these processes.\n\n\n45 CFR Part 170.315 (g-6)\n\n25.21 The EHR module's use of clinical document architecture (CDA) should be demonstrated and verified for conformance to the standards identified in 45 CFR Part 170.315 (g-6).\n\n\n45 CFR Part 170.315 (g-7\u2013g-9)\n\n25.22 The EHR module should include an application programming interface (API) that demonstrates the EHR's ability to uniquely identify a patient and corresponding ID\/token in a received records or data category request in order to accurately and securely meet the request for that patient's data. The API should be well documented.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#25._Health_information_technology\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#25._Health_information_technology<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 2 May 2022, at 20:54.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2,200 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","94577196babcc5bb87b20331aa12d805_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Specialty_Laboratory_Functions rootpage-LII_LIMSpec_Specialty_Laboratory_Functions skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Specialty Laboratory Functions<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover the specialty requirements that come with working in specific industries such as agriculture, pharmaceutical production, and <a href=\"https:\/\/www.limswiki.org\/index.php\/Forensic_science\" title=\"Forensic science\" class=\"wiki-link\" data-key=\"415d36a7b65494677b6d2873d5febec1\">forensic science<\/a>. You'll likely notice that most of the content here isn't covered by <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a>.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"17._Production_management\">17. Production management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.103\" target=\"_blank\">21 CFR Part 211.103<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40 (d)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.4 and 16.20<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.1<\/b> The system should be able to calculate and record theoretical and actual percentage of yield at various phases of processing, manufacturing, and packaging.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.103\" target=\"_blank\">21 CFR Part 211.103<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.2<\/b> The system should provide a means for verification and approval of yield calculations before release for reporting.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.20\" target=\"_blank\">21 CFR Part 820.20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.186\" target=\"_blank\">21 CFR Part 820.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 1.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.3<\/b> The system shall be able to maintain a production facility's quality system in a specific quality system record, in accordance with regulations and guidance such as 21 CFR Part 820.20 and 820.40 (U.S.), E.U. Commission Directive 2003\/94\/EC Article 11 (E.U.), and WHO Technical Report Series, #986, Annex 2, 1.0 (global).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.30\" target=\"_blank\">21 CFR Part 820.30<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (e)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.4<\/b> The system shall be able to create a design control document capable of recording the details surrounding device development, including control number, physical and performance requirements, final output, review, verification, approval, transfer, changes, and complete design history.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.181\" target=\"_blank\">21 CFR Part 820.181<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.184\" target=\"_blank\">21 CFR Part 820.184<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.5<\/b> The system shall be able to create a device master and device history record capable of recording all information described in 21 CFR Part 820.181 and 820.184.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.255\u2013260<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.130\" target=\"_blank\">21 CFR Part 211.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.134\" target=\"_blank\">21 CFR Part 211.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.20\" target=\"_blank\">21 CFR Part 211.20 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.50\" target=\"_blank\">21 CFR Part 211.50 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.202\" target=\"_blank\">21 CFR Part 225.202<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.60\" target=\"_blank\">21 CFR Part 820.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 2 and 4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f\u2013g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.25\u201330<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.6<\/b> The system shall be able to create a batch production record capable of recording complete information regarding batch production and control details such as, but not limited to, a unique batch, lot, or production run number; formulation; specific labeling and packaging; production steps; in-process and laboratory control results; the unique identifier of any equipment used; persons performing and\/or supervising operational steps; and the results of any pre-process or post-production inspections.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.205\u2013210<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.186\" target=\"_blank\">21 CFR Part 211.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.22\u201323<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.7<\/b> The system shall be able to create a master production and control record capable of recording complete information regarding master production and control details.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.150 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.186\" target=\"_blank\">21 CFR Part 211.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 10.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.8<\/b> The system shall require a new or modified master production and control record to be validated, reviewed, and approved before being implemented into production, including allowing that record to be electronically signed by one or more authorized individuals upon approval. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.150 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.22\" target=\"_blank\">21 CFR Part 211.22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.75\" target=\"_blank\">21 CFR Part 820.75<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b, f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.9<\/b> The system shall require a new or modified production and control record to be validated, reviewed, and approved before being implemented in production. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 14.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.10<\/b> The system shall be able to indicate if a sample consists of an in-process manufacturing material and track characteristics of the in-process material such as identity, strength, quality, purity, and approval status.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.11<\/b> The system shall provide a means to track the amount of time between production processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (f-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c) and (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.60\" target=\"_blank\">21 CFR Part 820.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.5.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 14.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.32\u201333<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.12<\/b> The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, certificates of conformity, shelf life or expiration date, storage location, status of examination, and status of approval for use. Any related specifications for those materials should be able to be linked to the received materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.125\" target=\"_blank\">21 CFR Part 211.125 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.7 and 14.22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.35<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.13<\/b> The system shall be capable of recording the changing quantity of inventoried non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, labeling, containers, and packaging materials), including batch and lot numbers and, if applicable, details of disposition after completion of production.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.113<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.125\" target=\"_blank\">21 CFR Part 211.125 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (d\u2013e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.90\" target=\"_blank\">21 CFR Part 820.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.160\" target=\"_blank\">21 CFR Part 820.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 23<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.4, 14.26, and 14.28<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.44\u201345<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.36<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.18\u201319<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.14<\/b> The system shall prevent the internal release for distribution of a completed production batch until an authorized individual has determined the batch's conformance to final specifications and has approved it for release. If a batch is nonconforming, the system shall be able to clearly document it as such (so as to not distribute it) and provide a review and disposition process. Such approval, rejection, review, and disposition activities shall be documented.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\/subpart-C\" target=\"_blank\">21 CFR Part 7 Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.139<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.38<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\/subpart-B\" target=\"_blank\">21 CFR Part 810 Subpart B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 15.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 6.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.32<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.15<\/b> The system shall provide a means to track and record recall activities of manufactured product and devices based on lot, batch, or other identifier, including storage location, necessary disposition details, and reconciliation between distributed and recovered quantities.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.520<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.165\" target=\"_blank\">21 CFR Part 211.165 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.204\" target=\"_blank\">21 CFR Part 211.204<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.71\" target=\"_blank\">21 CFR Part 212.71 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.90\" target=\"_blank\">21 CFR Part 820.90 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.29\u201330<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.16<\/b> The system should allow a completed production batch that has been rejected for use or a returned production batch to be flagged in the system for reprocessing or reworking if it meets relevant criteria.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.145<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 4.11.8.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, I - FSM 19.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 11.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.17<\/b> The system shall support environmental testing protocols for testing the production environment on a scheduled, reportable basis. That support shall include facility and sampling site management functionality that allows for highlighting specific test points in the facility, as well as support for offsite and randomized testing. The system should also allow associated samples, methods, tests, reports, and other documents to clearly indicate they correspond to specific environmental testing protocols.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"18._Statistical_trending_and_control_charts\">18. Statistical trending and control charts<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.7.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-10-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>18.1<\/b> The system should allow authorized users to configure the generation of statistical trending and control charts.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.7.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-10-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>18.2<\/b> The system should allow authorized users to choose specific sample types, tests, and parameters associated with the statistical trending and control charts that can be generated.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"19._Agriculture_and_food_data_management\">19. Agriculture and food data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/orapartners.fda.gov\/cs\/groups\/public\/documents\/document\/b2hh\/bmri\/~edisp\/rpohandbook.pdf\" target=\"_blank\">FDA Office of Regulatory Affairs Data Exchange (ORA DX) Program<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.1<\/b> The system should be able to create or convert an XML or XLS file to ORA DX template specifications, including the use of ORA DX terminology.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.2<\/b> The system shall allow for the assignment of the \"regulatory sample collection\" role and be able to produce a list of individuals in said role, including information such as name, locations assigned, part- or full-time role, and full-time equivalents (if any) used to meet any regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.3<\/b> The system shall allow for the documentation of sampling sites used for normal and regulatory sampling and be able to produce a complete list of such sites on-demand. The documentation should allow for details such as the addition of a unique, never-before-used site code; a region code; demographics; date added to or removed from the system; facility type; sample substrates or commodities available at the site; and relative volume information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.4.12 and 5.4.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.4<\/b> The system shall allow a site that is no longer active for sampling purposes be designated as inactive, yet be allowed to remain on any generated master list. Additionally, such inactive site shall maintain its unique site number in the event the site becomes reinstated as active.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.130\u2013135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507, Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.2, 3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - HACCP 1.X<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 2.2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 2.2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>19.5<\/b> The system shall allow for the development and documentation of hazard analysis and critical control points (HACCP) or other regulatory-driven food safety plan steps, as well as the implementation of those CCPs or steps into configurable laboratory workflow.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.6<\/b> The system shall require a new or modified HACCP or other regulatory-driven food safety plan be validated, reviewed, and approved before being implemented, including requiring that plan to be electronically signed by one or more authorized individuals upon approval.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.92<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>19.7<\/b> The system shall allow for the documentation and management of internal and external audit activities, while allowing samples, methods, tests, results, reports, documents, and more to be clearly associated with that corresponding audit activity.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"20._Environmental_data_management\">20. Environmental data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/geospatial\/epa-metadata-technical-specification\" target=\"_blank\">EPA Metadata Technical Specification<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.1<\/b> The system should support metadata requirements set forth by ISO 19115 and the EPA Metadata Technical Specification for reporting and data publishing purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.2<\/b> The system should support the manual entry or electronic transfer of EPA analytical service requests (ASRs), along with all the required fields of the ASR, including project identifier, project demographics, sample specifics, sample hazards, reporting requirements, and special requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/2015-07\/documents\/sedd52_specification.pdf\" target=\"_blank\">EPA SEDD Specification and Data Element Dictionary v5.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.3<\/b> The system should support the creation and transfer of Staged Electronic Data Deliverable (SEDD) files.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.10\" target=\"_blank\">40 CFR Part 3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/60\" target=\"_blank\">40 CFR Part 60 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/62\" target=\"_blank\">40 CFR Part 62 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/63\" target=\"_blank\">40 CFR Part 63 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>20.4<\/b> The system shall support generating electronic environmental reports (e.g., stationary source emissions tests) in either the EPA's Electronic Reporting Tool (ERT) special spreadsheet format or in an XML file format that complies with EPA-approved XML schema.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/denix.osd.mil\/edqw\/documents\/documents\/gen-data-validation-rev1\/\" target=\"_blank\">DoD General Data Validation Guidelines<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.5<\/b> The system should support electronic data deliverable (EDD) validation by linking the EDD to its quality assurance project plan (QAPP) and the appropriate stage of validation for the EDD's data type.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"21._Forensic_case_and_data_management\">21. Forensic case and data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.4.3<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1459-13 2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 4.1.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 4.1.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 4.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.1<\/b> The system shall be able to assign each piece of collected evidence and each scene a unique identifier using methodologies such as an ID with an incrementing integer (for sequential evidence numbers) or a user-defined naming format for meeting regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.6\u201310<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.2<\/b> The system shall be able to assign each case a unique case identifier that, in addition to an electronic signature, is able to be automatically placed on, at a maximum, each page of the case's associated examination and administration records.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.5.1.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.3<\/b> In addition to a unique case number, the system shall provide a means to add additional information to a case file, including, but not limited to, submitting agency, agency case number, date of case receipt, name of recipient, shipping and receipt details, items associated with the case and their unique designators, notes, test data, related reports, and other documentation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 (throughout)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 (throughout)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.4.3 and 4.5.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.4<\/b> The system should be able to document evidence using an ASTM-compliant evidence log, including, but not limited to, unique identifiers, investigator and custodian names, key dates and times, evidence conditions, and storage location.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.1.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.5<\/b> The system should be able to prevent a piece of evidence from being scheduled for destructive testing until an appropriate authorization for such analysis is acquired and documented.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.6<\/b> The system shall be able to record and maintain chain of custody of evidence that is subdivided in the laboratory in the same way that original evidence items are tracked.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.1.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.7<\/b> The system shall be capable of recording the secondary dissemination to an authorized agency or organization of criminal history record information (CHRI) sourced from U.S. Criminal Justice Information Services (CJIS).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.8<\/b> The system shall be able to record all National Crime Information Center (NCIC) and Interstate Identification Index (III) data transactions, clearly identifying the operator and authorized receiving agency or organization. III records shall also identify requester and recipient using a unique identifier.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(1) <\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.9<\/b> If the system provides remote access to authorized users over authorized devices, the remote access shall be monitored, controlled and documented, particularly for privileged functions. If remote access to privileged functions is allowed, virtual escorting that meets CJIS Security Policy 5.5.6 conditions will be required.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.1.1.1\u20132<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.1.2\u20133<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5(1) <\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.10<\/b> The system shall be capable of putting into place, in their entirety, either the \"basic password standards\" or \"advanced password standards\" described in CJIS Security Policy 5.6.2.1.1.1 and 5.6.2.1.1.2. If PIN and\/or one-time password is also used, the attributes in 5.6.2.1.2 and 5.6.2.1.3 shall also be required.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.11<\/b> If the system supports user-based certificates for authentication, the system shall be configurable enough to require them to be 1. user-specific, not device-specific, 2. used only by one user at any given time, and 3. activated for each use by, e.g., a passphrase or PIN.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2.1\u20132<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(2) <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-13, SC-28, and SC-28(1)<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.12<\/b> The system shall allow \"encryption in transit\" and \"encryption at rest\" of criminal justice information (CJI) that meets or exceeds the requirements of CJIS Security Policy 5.10.1.2.1 and 5.10.1.2.2.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.13<\/b> If the system is cloud-based, the vendor shall ensure that CJI is stored in databases located within the physical boundaries of APB-member countries and within the legal authority of APB-member agencies. Additionally, the vendor shall agree to not use any metadata derived from unencrypted CJI for commercial, advertising, or other purposes, unless specifically permitted for limited within the service agreement.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.11.1\u20132<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.14<\/b> If the system is cloud-based, the vendor should agree to FBI and CSA compliance and security audits of CJI.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.3.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.15<\/b> If the system is capable of being run in a virtual environment, it shall meet the virtualization requirements set forth in CJIS Security Policy 5.10.3.2 and best practices set forth in CJIS Security Policy Appendix G.1.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6(4)<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-39<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.16<\/b> The system should provide separate processing domains in order to not only allow for more granular allocation of user privileges, but also to prevent one process from modifying the executing code of another process.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2(1\u20132), IA-2(12), and IA-8(1)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.17<\/b> The system should support the use of personal identity verification\u2014a U.S. Federal government-wide credential system\u2014and other forms of hardware-based (i.e., public key infrastructure or PKI) token authentication, while electronically verifying those credentials and any configured token quality requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.18<\/b> The system should support the identification and tagging of infrequently performed forensic tests or analyses in order to alert the analyst and other stakeholders that additional competency verification or method validation is required before performing the test or analysis.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.19<\/b> The system should allow case records to be scheduled for periodic administrative and technical review by individuals not connected with the case. The conducted review should indicate details such as who conducted the review, what the results were, and when the review was completed. If non-conforming results were discovered, records of determination and resolution should be appended to the case record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.20<\/b> The system should be able to document examiner testimony and allow such testimony to be scheduled for periodic evaluation. The conducted evaluation should indicate details such as who conducted the evaluation, what the results were, and when the review was completed. If non-conforming results were discovered, related records of determination and resolution should be maintained in the system.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"22._Clinical_and_public_health_data_management\">22. Clinical and public health data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/phin\/tools\/phinms\/index.html\" target=\"_blank\">CDC PHIN Messaging System<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.1<\/b> The system should be capable of interfacing with the Center for Disease Control and Prevention's PHIN Messaging System.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.5<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>22.2<\/b> The system should support Human Genome Variation Society (HGVS) nomenclature and terminology for sequence variants.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.3<\/b> The system should be able to collect sufficient test utilization information to make necessity checks on ordered tests against established benchmarks.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healthit.gov\/isa\/united-states-core-data-interoperability-uscdi\" target=\"_blank\">ONC USCDI v2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.4<\/b> The system should support the United States Core Data for Interoperability (USCDI) v2 standard, which in turn supports data interoperability across multiple clinical settings.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"23._Veterinary_data_management\">23. Veterinary data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphis.usda.gov\/aphis\/ourfocus\/animalhealth\/lab-info-services\/nahln\/ct_nahln_it\" target=\"_blank\">NAHLN Information Technology System<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/venomcoding.org\/\" target=\"_blank\">VeNom Coding Group<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vtsl.vetmed.vt.edu\/\" target=\"_blank\">Veterinary Terminology Services Laboratory<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.1<\/b> The system should support standardized veterinary clinical terminology such as that found in the Veterinary Extension of SNOMED CT and the Veterinary Nomenclature (VeNom) Codes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.icar.org\/Guidelines\/15-Data-Exchange.pdf\" target=\"_blank\">ICAR 15 Data Exchange<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vichsec.org\/en\/guidelines\/general\" target=\"_blank\">VICH GL53<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.2<\/b> The system should be able to exchange data, when necessary, in a fashion that meets International Committee for Animal Recording (ICAR) and Veterinary International Conference on Harmonization (VICH) electronic data exchange guidelines.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphis.usda.gov\/animal_health\/nahln\/downloads\/MessagingQuickGuide.pdf\" target=\"_blank\">NAHLN HL7 Messaging Quick User Guide<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.3<\/b> The system should support National Animal Health Laboratory Network (NAHLN), and, by extension, Health Level 7 (HL7) result messaging.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"24._Scientific_data_management\">24. Scientific data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.1<\/b> The system shall capture raw instrument data and metadata either as an electronic file or directly via RS-232 or TCP\/IP communication.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.2<\/b> The scientific data management system (SDMS) should provide a checksum verification of source and destination data and store that verification data in a secure server with controlled access.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.3<\/b> The system shall store metadata related to raw instrument data in a database in such a way that the original data generated by instruments for specific samples and tests is easy to retrieve.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.4<\/b> The system should be capable of capturing a complete and readable copy of original data and any previous versions of modified data in order to maintain the integrity of that data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD AAVLD Requirements for an AVMDL Sec. 4.10.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.5<\/b> The system should secure raw data such that it can't be deleted and provide version control when data is modified by any user or specific software.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.6<\/b> The SDMS should provide tools for helping a laboratory achieve the U.S. Food and Drug Administration's defined ALCOA principles.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.7<\/b> The SDMS shall provide security and access controls for protecting stored data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.8<\/b> The SDMS shall record an audit trail for each and every record created and modified, using version control.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.9<\/b> The SDMS shall provide proper systems for backing up, restoring, and archiving data for long-term use.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"25._Health_information_technology\">25. Health information technology<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-1\u2013a-4)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.1<\/b> The electronic health record (EHR) module should provide computerized provider order entry (CPOE) functionality for medication orders, laboratory orders, and diagnostic imaging, including making checks for potential drug-drug and drug-allergy interactions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-5)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-11\u2013a-12)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-15)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.2<\/b> The EHR module should allow authorized personnel to record, change, and access patient demographic data, including, but not limited to, race and ethnicity, patient's preferred language, birth sex, current sex, sexual orientation, gender identity, birth date, smoking status, alcohol use, family health history, psychological aspects, social aspects, and behavioral aspects.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-6\u2013a-8)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-10)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-14)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.3<\/b> The EHR module should allow authorized personnel to record, change, and access a patient's active problem list, medication list, medication allergy list, preferred drug list, and implantable device list, incorporating, where appropriate, at a minimum the SNOMED CT nomenclature standard.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-19)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.4<\/b> The EHR module should incorporate configurable, role-based clinical decision support tools capable of allowing authorized personnel to trigger electronic interventions based on liked reference information standardized to Health Level 7 (HL7) Version 3 implementation guides. The reference information should be sourced.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-13)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.5<\/b> The EHR module should be able to identify education resources specific to a patient's active problem and medication lists. The educational resources should be standardized to Health Level 7 (HL7) Version 3 implementation guides.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-1\u2013b-2; b-4\u2013b-5)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.6<\/b> The EHR module should allow authorized personnel to create, view, send, and receive transition of care or referral summaries in such a way that the summary is properly formatted, matched to the correct patient, and reconciled according to the standards and protocols outlined in 45 CFR Part 170.315 (b-1), (b-2), (b-4), and (b-5).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.7<\/b> The EHR module should allow authorized personnel to conduct electronic prescribing actions such as creating, changing, cancelling, and refilling prescriptions, incorporating at least the RxNorm and NCPDP SCRIPT standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-6)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.8<\/b> The EHR module should allow authorized personnel to configure, create, and store data exports, incorporating at least HL7 Version 3 implementation standards, as well as SNOMED CT and ICD-9 standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-7\u2013b-8)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.9<\/b> The EHR module should allow for the secure creation, sending, and receipt of restricted summary records, incorporating HL7 Version 3 implementation standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-9)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.10<\/b> The EHR module should allow authorized personnel to create, record, change, access, and receive care plan information, incorporating HL7 Version 3 implementation standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (c)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.11<\/b> The EHR module should provide a means to record, calculate, import, export, filter, and report on clinical quality measures according to the standards outlined in 45 CFR Part 170.315 (c).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.12<\/b> The EHR module shall provide security and access controls for protecting stored data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.13<\/b> The EHR module shall record an audit trail for each and every record created and modified, using version control.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.14<\/b> The EHR module shall either encrypt electronic health information on end-user devices after use of the technology on the device stops or prevent electronic health information from being stored on end-user devices after use of the technology on the device stops.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-8)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.15<\/b> The EHR module shall ensure that electronically exchanged health information has not been altered during the transfer process, using at least a hashing algorithm secured to SHA-2 or better.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-11)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.16<\/b> The EHR module should be capable of recording patient disclosures made for treatment, payment, and health care operations.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (e-1)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.17<\/b> The EHR module should provide a means for patients and their authorized representatives to view, download, and transmit their personal health information and activity history log from the EHR via an internet-based technology, using the standards outlined in 45 CFR Part 170.315 (e-1).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (e-2\u2013e-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.18<\/b> The EHR module should provide a means for authorized users to securely send messages to and receive messages from patients, at the same time allowing for the recording, accessing, and linking of information shared by the patient electronically (as well as directly).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (f)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.19<\/b> The EHR module should allow vital patient information as it relates to public health to be transmitted to immunization registries, cancer registries, and public health agencies, as well as be accessed after the fact. This includes, but is not limited to, immunization history, surveillance information, laboratory test results, cancer case information, case reports, antimicrobial reporting, and health care survey information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-3\u2013g-5)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.20<\/b> The EHR developer should use user-centered and accessibility-centered design processes for creating and testing the EHR's functionality. A quality management system should be used during these processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-6)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.21<\/b> The EHR module's use of clinical document architecture (CDA) should be demonstrated and verified for conformance to the standards identified in 45 CFR Part 170.315 (g-6).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-7\u2013g-9)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.22<\/b> The EHR module should include an application programming interface (API) that demonstrates the EHR's ability to uniquely identify a patient and corresponding ID\/token in a received records or data category request in order to accurately and securely meet the request for that patient's data. The API should be well documented.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173544\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.091 seconds\nReal time usage: 0.100 seconds\nPreprocessor visited node count: 377\/1000000\nPost\u2010expand include size: 77243\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 20.131 1 -total\n 12.96% 2.609 1 Template:LIMSpec\/Production_management\n 11.73% 2.361 1 Template:LIMSpec\/Environmental_data_management\n 11.17% 2.248 1 Template:LIMSpec\/Veterinary_data_management\n 11.10% 2.234 1 Template:LIMSpec\/Health_information_technology\n 10.88% 2.191 1 Template:LIMSpec\/Scientific_data_management\n 9.85% 1.984 1 Template:LIMSpec\/Public_health_data_management\n 9.80% 1.973 1 Template:LIMSpec\/Forensic_case_and_data_management\n 9.37% 1.887 1 Template:LIMSpec\/Agriculture_and_food_data_management\n 9.11% 1.833 1 Template:LIMSpec\/Statistical_trending_and_control_charts\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11203-0!canonical and timestamp 20221202173544 and revision id 47561. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#25._Health_information_technology\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#25._Health_information_technology<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","94577196babcc5bb87b20331aa12d805_images":[],"94577196babcc5bb87b20331aa12d805_timestamp":1670002545,"b6db2dcdf3009db85f6affb0fff9d348_type":"article","b6db2dcdf3009db85f6affb0fff9d348_title":"24. Scientific data management","b6db2dcdf3009db85f6affb0fff9d348_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#24._Scientific_data_management","b6db2dcdf3009db85f6affb0fff9d348_plaintext":"\n\nLII:LIMSpec\/Specialty Laboratory FunctionsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover the specialty requirements that come with working in specific industries such as agriculture, pharmaceutical production, and forensic science. You'll likely notice that most of the content here isn't covered by ASTM E1578-18.\n\n17. Production management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 211.103\r\n21 CFR Part 226.40 (d)\r\nWHO Technical Report Series, #986, Annex 2, 16.4 and 16.20\n\n17.1 The system should be able to calculate and record theoretical and actual percentage of yield at various phases of processing, manufacturing, and packaging.\n\n\n21 CFR Part 211.103\n\n17.2 The system should provide a means for verification and approval of yield calculations before release for reporting.\n\n\n\n21 CFR Part 820.20\r\n\n21 CFR Part 820.40\r\n\n21 CFR Part 820.186\r\n\nE.U. Commission Directive 2003\/94\/EC Article 11\r\n\nWHO Technical Report Series, #986, Annex 2, 1.0\n\n\n17.3 The system shall be able to maintain a production facility's quality system in a specific quality system record, in accordance with regulations and guidance such as 21 CFR Part 820.20 and 820.40 (U.S.), E.U. Commission Directive 2003\/94\/EC Article 11 (E.U.), and WHO Technical Report Series, #986, Annex 2, 1.0 (global).\n\n\n21 CFR Part 820.30\r\n21 CFR Part 820.120 (e)\n\n17.4 The system shall be able to create a design control document capable of recording the details surrounding device development, including control number, physical and performance requirements, final output, review, verification, approval, transfer, changes, and complete design history.\n\n\n21 CFR Part 820.181\r\n21 CFR Part 820.184\n\n17.5 The system shall be able to create a device master and device history record capable of recording all information described in 21 CFR Part 820.181 and 820.184.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 111.255\u2013260\r\n\n21 CFR Part 114.100 (b)\r\n\n21 CFR Part 211.105 (b)\r\n\n21 CFR Part 211.130 (e)\r\n\n21 CFR Part 211.134 (c)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.20 (d)\r\n\n21 CFR Part 211.50 (c)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 225.202\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 820.60\r\n\n21 CFR Part 820.70 (a)\r\n\n21 CFR Part 820.80 (c)\r\n\n21 CFR Part 820.120 (d)\r\n\nBRC GSFS, Issue 8, 6.1.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.1.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 8.1\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.1\r\n\nFDA Hazard Analysis Critical Control Point Principle 2 and 4\r\n\nFDA Hazard Analysis Critical Control Point Principle 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11\r\n\nIFS Food 7, Part 2, 4.2.1.1\r\n\nIFS Food 7, Part 2, 4.18.1\r\n\nIFS PACsecure 2, Part 2, 4.2.1.1\r\n\nIFS PACsecure 2, Part 2, 4.18.1\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (3)\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f\u2013g)\r\n\nWHO Technical Report Series, #986, Annex 2, 15.25\u201330\n\n\n17.6 The system shall be able to create a batch production record capable of recording complete information regarding batch production and control details such as, but not limited to, a unique batch, lot, or production run number; formulation; specific labeling and packaging; production steps; in-process and laboratory control results; the unique identifier of any equipment used; persons performing and\/or supervising operational steps; and the results of any pre-process or post-production inspections.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.100 (e)\r\n\n21 CFR Part 111.205\u2013210\r\n\n21 CFR Part 114.100 (b)\r\n\n21 CFR Part 211.186\r\n\n21 CFR Part 212.50 (b)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nBRC GSFS, Issue 8, 3.6.2\r\n\nBRC GSFS, Issue 8, 9.2.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.1.2\r\n\nFDA Hazard Analysis Critical Control Point Principle 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11\r\n\nIFS Food 7, Part 2, 4.2.1.1\r\n\nIFS PACsecure 2, Part 2, 4.2.1.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 15.22\u201323\n\n\n17.7 The system shall be able to create a master production and control record capable of recording complete information regarding master production and control details.\n\n\n\n21 CFR Part 106.100 (e)\r\n\n21 CFR Part 111.123 (a)\r\n\n21 CFR Part 114.100 (c)\r\n\n21 CFR Part 117.150 (d)\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.186\r\n\n21 CFR Part 212.50 (b)\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nBRC GSFS, Issue 8, 9.2.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 10.3\u20134\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.2\r\n\nIFS Food 7, Part 2, 4.2.1.2\r\n\nIFS Food 7, Part 2, 4.3.x\r\n\nIFS Food 7, Part 2, 5.11\r\n\nIFS PACsecure 2, Part 2, 4.2.1.2\r\n\nIFS PACsecure 2, Part 2, 4.3.x\r\n\nIFS PACsecure 2, Part 2, 5.11\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b)\r\n\nWHO Technical Report Series, #986, Annex 2, 4.0\n\n\n17.8 The system shall require a new or modified master production and control record to be validated, reviewed, and approved before being implemented into production, including allowing that record to be electronically signed by one or more authorized individuals upon approval. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n\n\n\n21 CFR Part 111.123 (a)\r\n\n21 CFR Part 114.100 (c)\r\n\n21 CFR Part 117.150 (d)\r\n\n21 CFR Part 211.22\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 820.70 (b)\r\n\n21 CFR Part 820.75\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 10.3\r\n\nIFS Food 7, Part 2, 4.2.1.2\r\n\nIFS Food 7, Part 2, 4.3.x\r\n\nIFS Food 7, Part 2, 5.11\r\n\nIFS PACsecure 2, Part 2, 4.2.1.2\r\n\nIFS PACsecure 2, Part 2, 4.3.x\r\n\nIFS PACsecure 2, Part 2, 5.11\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b, f)\r\n\nWHO Technical Report Series, #986, Annex 2, 4.0\n\n\n17.9 The system shall require a new or modified production and control record to be validated, reviewed, and approved before being implemented in production. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n\n\n\n21 CFR Part 211.110\r\n\n21 CFR Part 212.50\r\n\n21 CFR Part 820.80 (c)\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\r\n\nISO\/TS 22002-1:2009, 14.3\n\n\n17.10 The system shall be able to indicate if a sample consists of an in-process manufacturing material and track characteristics of the in-process material such as identity, strength, quality, purity, and approval status.\n\n\n21 CFR Part 211.111\n\n17.11 The system shall provide a means to track the amount of time between production processes.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.80\r\n\n21 CFR Part 106.100 (f-6)\r\n\n21 CFR Part 117.420\r\n\n21 CFR Part 211.122 (c)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 212.20 (b)\r\n\n21 CFR Part 212.40 (c) and (e)\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.40 (b)\r\n\n21 CFR Part 226.42\r\n\n21 CFR Part 606.120 (b)\r\n\n21 CFR Part 820.60\r\n\n21 CFR Part 820.80 (b)\r\n\n21 CFR Part 820.120 (b)\r\n\nBRC GSFS, Issue 8, 3.6.1\r\n\nBRC GSFS, Issue 8, 3.9.2\r\n\nBRC GSFS, Issue 8, 5.4.4\r\n\nBRC GSFS, Issue 8, 3.5.1\r\n\nBRC GSFS, Issue 8, 9.5.1\u20132\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17\r\n\nIFS Food 7, Part 2, 4.5.2\r\n\nIFS Food 7, Part 2, 4.18.1\r\n\nIFS PACsecure 2, Part 2, 4.5.2\r\n\nIFS PACsecure 2, Part 2, 4.18.1\r\n\nISO\/TS 22002-1:2009, 9.3\r\n\nISO\/TS 22002-1:2009, 14.2\r\n\nISO\/TS 22002-4:2013, 4.6.3\r\n\nISO\/TS 22002-4:2013, 4.11.2\r\n\nISO\/TS 22002-6:2016, 4.6.3\r\n\nISO\/TS 22002-6:2016, 4.11.2\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nWHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21\r\n\nWHO Technical Report Series, #986, Annex 2, 15.32\u201333\n\n\n17.12 The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, certificates of conformity, shelf life or expiration date, storage location, status of examination, and status of approval for use. Any related specifications for those materials should be able to be linked to the received materials.\n\n\n\n21 CFR Part 211.122 (e)\r\n\n21 CFR Part 211.125 (d)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.42\r\n\nBRC GSFS, Issue 8, 3.5.3\r\n\nBRC GSFS, Issue 8, 9.5.3\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17\r\n\nWHO Technical Report Series, #986, Annex 2, 14.7 and 14.22\r\n\nWHO Technical Report Series, #986, Annex 2, 16.35\n\n\n17.13 The system shall be capable of recording the changing quantity of inventoried non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, labeling, containers, and packaging materials), including batch and lot numbers and, if applicable, details of disposition after completion of production.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.70\r\n\n21 CFR Part 111.113\r\n\n21 CFR Part 111.123 (b)\r\n\n21 CFR Part 114.100 (d)\r\n\n21 CFR Part 120.10\r\n\n21 CFR Part 123.6\r\n\n21 CFR Part 211.122 (e)\r\n\n21 CFR Part 211.125 (d)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.42\r\n\n21 CFR Part 606.100 (c)\r\n\n21 CFR Part 820.80 (d\u2013e)\r\n\n21 CFR Part 820.90\r\n\n21 CFR Part 820.160\r\n\nBRC GSFS, Issue 8, 3.8.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.2\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 23\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\nIFS Food 7, Part 2, 5.7.1\r\n\nIFS Food 7, Part 2, 5.10\r\n\nIFS PACsecure 2, Part 2, 5.7.1\r\n\nIFS PACsecure 2, Part 2, 5.10\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.5\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.7\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.5\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.7\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.5\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.7\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (g)\r\n\nWHO Technical Report Series, #986, Annex 2, 14.4, 14.26, and 14.28\r\n\nWHO Technical Report Series, #986, Annex 2, 15.44\u201345\r\n\nWHO Technical Report Series, #986, Annex 2, 16.36\r\n\nWHO Technical Report Series, #986, Annex 2, 17.18\u201319\n\n\n17.14 The system shall prevent the internal release for distribution of a completed production batch until an authorized individual has determined the batch's conformance to final specifications and has approved it for release. If a batch is nonconforming, the system shall be able to clearly document it as such (so as to not distribute it) and provide a review and disposition process. Such approval, rejection, review, and disposition activities shall be documented.\n\n\n\n21 CFR Part 7 Subpart C\r\n\n21 CFR Part 117.139\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 507.38\r\n\n21 CFR Part 810 Subpart B\r\n\nBRC GSFS, Issue 8, 3.11.2\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.5\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\nIFS Food 7, Part 2, 5.9.2\r\n\nIFS PACsecure 2, Part 2, 5.9.2\r\n\nISO\/TS 22002-1:2009, 15.x\r\n\nISO\/TS 22002-4:2013, 4.12\r\n\nISO\/TS 22002-6:2016, 4.12\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.6.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.6.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.3\r\n\nWHO Technical Report Series, #986, Annex 2, 6.0\r\n\nWHO Technical Report Series, #986, Annex 2, 14.32\n\n\n17.15 The system shall provide a means to track and record recall activities of manufactured product and devices based on lot, batch, or other identifier, including storage location, necessary disposition details, and reconciliation between distributed and recovered quantities.\n\n\n\n21 CFR Part 111.520\r\n\n21 CFR Part 211.165 (f)\r\n\n21 CFR Part 211.204\r\n\n21 CFR Part 212.71 (d)\r\n\n21 CFR Part 820.90 (b-2)\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.6\r\n\nWHO Technical Report Series, #986, Annex 2, 14.29\u201330\n\n\n17.16 The system should allow a completed production batch that has been rejected for use or a returned production batch to be flagged in the system for reprocessing or reworking if it meets relevant criteria.\n\n\n\n21 CFR Part 112.145\r\n\nBRC GSFS, Issue 8, 4.11.8.x\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, I - FSM 19.2\r\n\nISO\/TS 22002-1:2009, 11.5\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.8\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.8\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.8\n\n\n17.17 The system shall support environmental testing protocols for testing the production environment on a scheduled, reportable basis. That support shall include facility and sampling site management functionality that allows for highlighting specific test points in the facility, as well as support for offsite and randomized testing. The system should also allow associated samples, methods, tests, reports, and other documents to clearly indicate they correspond to specific environmental testing protocols.\n\n\n\n18. Statistical trending and control charts \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 820.250\r\n\nAIHA-LAP Policies 2018 2A.7.7.1.3\r\n\nASTM E1578-18 E-10-1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7.2.8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.8\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 9\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\n\n\n18.1 The system should allow authorized users to configure the generation of statistical trending and control charts.\n\n\n\n21 CFR Part 820.250\r\n\nAIHA-LAP Policies 2018 2A.7.7.1.3\r\n\nASTM E1578-18 E-10-2\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7.2.8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.8\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 9\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\n\n\n18.2 The system should allow authorized users to choose specific sample types, tests, and parameters associated with the statistical trending and control charts that can be generated.\n\n\n\n19. Agriculture and food data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nFDA Office of Regulatory Affairs Data Exchange (ORA DX) Program\n\n19.1 The system should be able to create or convert an XML or XLS file to ORA DX template specifications, including the use of ORA DX terminology.\n\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\nUSDA Sampling Procedures for PDP 5.3\r\nUSDA Sampling Procedures for PDP 6.2\n\n19.2 The system shall allow for the assignment of the \"regulatory sample collection\" role and be able to produce a list of individuals in said role, including information such as name, locations assigned, part- or full-time role, and full-time equivalents (if any) used to meet any regulatory requirements.\n\n\nUSDA Sampling Procedures for PDP 5.4\n\n19.3 The system shall allow for the documentation of sampling sites used for normal and regulatory sampling and be able to produce a complete list of such sites on-demand. The documentation should allow for details such as the addition of a unique, never-before-used site code; a region code; demographics; date added to or removed from the system; facility type; sample substrates or commodities available at the site; and relative volume information.\n\n\nUSDA Sampling Procedures for PDP 5.4.12 and 5.4.14\n\n19.4 The system shall allow a site that is no longer active for sampling purposes be designated as inactive, yet be allowed to remain on any generated master list. Additionally, such inactive site shall maintain its unique site number in the event the site becomes reinstated as active.\n\n\n\n21 CFR Part 117.130\u2013135\r\n\n21 CFR Part 120 (throughout)\r\n\n21 CFR Part 123.6\r\n\n21 CFR Part 507, Subpart C\r\n\n61 FR 38806, 9 CFR Part 417.x\r\n\nBRC GSFS, Issue 8, 2.x\r\n\nCodex Alimentarius CXC 1-1969, Ch.2, 3.x\r\n\nE.U. Commission Reg. No. 852\/2004 Article 5\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - HACCP 1.X\r\n\nIFS Food 7, Part 2, 2.2.x\r\n\nIFS PACsecure 2, Part 2, 2.2.x\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.3\n\n\n19.5 The system shall allow for the development and documentation of hazard analysis and critical control points (HACCP) or other regulatory-driven food safety plan steps, as well as the implementation of those CCPs or steps into configurable laboratory workflow.\n\n\n61 FR 38806, 9 CFR Part 417.4\n\n19.6 The system shall require a new or modified HACCP or other regulatory-driven food safety plan be validated, reviewed, and approved before being implemented, including requiring that plan to be electronically signed by one or more authorized individuals upon approval.\n\n\n\n21 CFR Part 106.90\r\n\n21 CFR Part 106.92\r\n\n21 CFR Part 106.94\r\n\n21 CFR Part 106.100 (j)\r\n\nBRC GSFS, Issue 8, 3.4.x\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 20\r\n\nIFS Food 7, Part 2, 5.1\r\n\nIFS PACsecure 2, Part 2, 5.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.4\n\n\n19.7 The system shall allow for the documentation and management of internal and external audit activities, while allowing samples, methods, tests, results, reports, documents, and more to be clearly associated with that corresponding audit activity.\n\n\n\n20. Environmental data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nEPA Metadata Technical Specification\n\n20.1 The system should support metadata requirements set forth by ISO 19115 and the EPA Metadata Technical Specification for reporting and data publishing purposes.\n\n\nEPA ERLN Laboratory Requirements 3.3\n\n20.2 The system should support the manual entry or electronic transfer of EPA analytical service requests (ASRs), along with all the required fields of the ASR, including project identifier, project demographics, sample specifics, sample hazards, reporting requirements, and special requirements.\n\n\nEPA SEDD Specification and Data Element Dictionary v5.2\n\n20.3 The system should support the creation and transfer of Staged Electronic Data Deliverable (SEDD) files.\n\n\n\n40 CFR Part 3.10\r\n\n40 CFR Part 60 (throughout)\r\n\n40 CFR Part 62 (throughout)\r\n\n40 CFR Part 63 (throughout)\n\n\n20.4 The system shall support generating electronic environmental reports (e.g., stationary source emissions tests) in either the EPA's Electronic Reporting Tool (ERT) special spreadsheet format or in an XML file format that complies with EPA-approved XML schema.\n\n\nDoD General Data Validation Guidelines\n\n20.5 The system should support electronic data deliverable (EDD) validation by linking the EDD to its quality assurance project plan (QAPP) and the appropriate stage of validation for the EDD's data type.\n\n\n\n21. Forensic case and data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.4.3\nASTM E1188-11 3.2.3\r\n\nASTM E1188-11 3.4.1\r\n\nASTM E1459-13 2.1\r\n\nASTM E1459-13 4.1.1\u20132\r\n\nASTM E1459-13 4.1.4.2\r\n\nASTM E1459-13 4.2.2\u20133\r\n\nASTM E1492-11 4.1.1\r\n\nASTM E1492-11 4.1.5\n\n\n21.1 The system shall be able to assign each piece of collected evidence and each scene a unique identifier using methodologies such as an ID with an incrementing integer (for sequential evidence numbers) or a user-defined naming format for meeting regulatory requirements.\n\n\nA2LA C223 4.13\r\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.6\u201310\r\nASTM E1492-11 4.1.1\r\n\n\n21.2 The system shall be able to assign each case a unique case identifier that, in addition to an electronic signature, is able to be automatically placed on, at a maximum, each page of the case's associated examination and administration records.\n\n\n\nA2LA C223 4.13\r\n\nASTM E1492-11 4.1.1.1\u20132\r\n\nASTM E1492-11 4.1.4\u20135\r\n\nASTM E1492-11 4.2.2\u20133\r\n\nASTM E1492-11 4.5.1.1\n\n\n21.3 In addition to a unique case number, the system shall provide a means to add additional information to a case file, including, but not limited to, submitting agency, agency case number, date of case receipt, name of recipient, shipping and receipt details, items associated with the case and their unique designators, notes, test data, related reports, and other documentation.\n\n\nASTM E1188-11 (throughout)\r\nASTM E1459-13 (throughout)\r\nASTM E1492-11 4.4.3 and 4.5.1\n\n21.4 The system should be able to document evidence using an ASTM-compliant evidence log, including, but not limited to, unique identifiers, investigator and custodian names, key dates and times, evidence conditions, and storage location.\n\n\nASTM E1492-11 4.3.1.1\n\n21.5 The system should be able to prevent a piece of evidence from being scheduled for destructive testing until an appropriate authorization for such analysis is acquired and documented.\n\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1.1\r\nASTM E1492-11 4.1.2\n\n21.6 The system shall be able to record and maintain chain of custody of evidence that is subdivided in the laboratory in the same way that original evidence items are tracked.\n\n\nCJIS Security Policy 5.1.3\n\n21.7 The system shall be capable of recording the secondary dissemination to an authorized agency or organization of criminal history record information (CHRI) sourced from U.S. Criminal Justice Information Services (CJIS).\n\n\nCJIS Security Policy 5.4.7\n\n21.8 The system shall be able to record all National Crime Information Center (NCIC) and Interstate Identification Index (III) data transactions, clearly identifying the operator and authorized receiving agency or organization. III records shall also identify requester and recipient using a unique identifier.\n\n\nCJIS Security Policy 5.5.6\r\nNIST 800-53, Rev. 5, AC-17(1) \r\n\n\n21.9 If the system provides remote access to authorized users over authorized devices, the remote access shall be monitored, controlled and documented, particularly for privileged functions. If remote access to privileged functions is allowed, virtual escorting that meets CJIS Security Policy 5.5.6 conditions will be required.\n\n\nCJIS Security Policy 5.6.2.1.1.1\u20132\r\nCJIS Security Policy 5.6.2.1.2\u20133\r\nNIST 800-53, Rev. 5, IA-5(1) \r\n\n\n21.10 The system shall be capable of putting into place, in their entirety, either the \"basic password standards\" or \"advanced password standards\" described in CJIS Security Policy 5.6.2.1.1.1 and 5.6.2.1.1.2. If PIN and\/or one-time password is also used, the attributes in 5.6.2.1.2 and 5.6.2.1.3 shall also be required.\n\n\nCJIS Security Policy 5.6.2.2\n\n21.11 If the system supports user-based certificates for authentication, the system shall be configurable enough to require them to be 1. user-specific, not device-specific, 2. used only by one user at any given time, and 3. activated for each use by, e.g., a passphrase or PIN.\n\n\nCJIS Security Policy 5.10.1.2.1\u20132\r\n\nCJIS Security Policy Appendix G.6\r\n\nNIST 800-53, Rev. 5, AC-17(2) \r\n\nNIST 800-53, Rev. 5, SC-13, SC-28, and SC-28(1)\r\n\n\n\n21.12 The system shall allow \"encryption in transit\" and \"encryption at rest\" of criminal justice information (CJI) that meets or exceeds the requirements of CJIS Security Policy 5.10.1.2.1 and 5.10.1.2.2.\n\n\nCJIS Security Policy 5.10.1.5\n\n21.13 If the system is cloud-based, the vendor shall ensure that CJI is stored in databases located within the physical boundaries of APB-member countries and within the legal authority of APB-member agencies. Additionally, the vendor shall agree to not use any metadata derived from unencrypted CJI for commercial, advertising, or other purposes, unless specifically permitted for limited within the service agreement.\n\n\nCJIS Security Policy 5.11.1\u20132\n\n21.14 If the system is cloud-based, the vendor should agree to FBI and CSA compliance and security audits of CJI.\n\n\nCJIS Security Policy 5.10.3.2\r\nCJIS Security Policy Appendix G.1\n\n21.15 If the system is capable of being run in a virtual environment, it shall meet the virtualization requirements set forth in CJIS Security Policy 5.10.3.2 and best practices set forth in CJIS Security Policy Appendix G.1.\n\n\nCJIS Security Policy Appendix G.5\r\nNIST 800-53, Rev. 5, AC-6(4)\r\n\nNIST 800-53, Rev. 5, SC-39\r\n\n\n\n21.16 The system should provide separate processing domains in order to not only allow for more granular allocation of user privileges, but also to prevent one process from modifying the executing code of another process.\n\n\nNIST 800-53, Rev. 5, IA-2(1\u20132), IA-2(12), and IA-8(1)\n\n21.17 The system should support the use of personal identity verification\u2014a U.S. Federal government-wide credential system\u2014and other forms of hardware-based (i.e., public key infrastructure or PKI) token authentication, while electronically verifying those credentials and any configured token quality requirements.\n\n\nA2LA C223 5.4\n\n21.18 The system should support the identification and tagging of infrequently performed forensic tests or analyses in order to alert the analyst and other stakeholders that additional competency verification or method validation is required before performing the test or analysis.\n\n\nA2LA C223 5.9\n\n21.19 The system should allow case records to be scheduled for periodic administrative and technical review by individuals not connected with the case. The conducted review should indicate details such as who conducted the review, what the results were, and when the review was completed. If non-conforming results were discovered, records of determination and resolution should be appended to the case record.\n\n\nA2LA C223 5.9\n\n21.20 The system should be able to document examiner testimony and allow such testimony to be scheduled for periodic evaluation. The conducted evaluation should indicate details such as who conducted the evaluation, what the results were, and when the review was completed. If non-conforming results were discovered, related records of determination and resolution should be maintained in the system.\n\n\n\n22. Clinical and public health data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nCDC PHIN Messaging System\n\n22.1 The system should be capable of interfacing with the Center for Disease Control and Prevention's PHIN Messaging System.\n\n\nACMG Technical Standards for Clinical Genetics Laboratories G1.5\r\n\n\n22.2 The system should support Human Genome Variation Society (HGVS) nomenclature and terminology for sequence variants.\n\n\nCLSI QMS22 2.1.2.3\n\n22.3 The system should be able to collect sufficient test utilization information to make necessity checks on ordered tests against established benchmarks.\n\n\nONC USCDI v2\n\n22.4 The system should support the United States Core Data for Interoperability (USCDI) v2 standard, which in turn supports data interoperability across multiple clinical settings.\n\n\n\n23. Veterinary data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nNAHLN Information Technology System\r\nVeNom Coding Group\r\nVeterinary Terminology Services Laboratory\n\n23.1 The system should support standardized veterinary clinical terminology such as that found in the Veterinary Extension of SNOMED CT and the Veterinary Nomenclature (VeNom) Codes.\n\n\nICAR 15 Data Exchange\r\nVICH GL53\n\n23.2 The system should be able to exchange data, when necessary, in a fashion that meets International Committee for Animal Recording (ICAR) and Veterinary International Conference on Harmonization (VICH) electronic data exchange guidelines.\n\n\nNAHLN HL7 Messaging Quick User Guide\n\n23.3 The system should support National Animal Health Laboratory Network (NAHLN), and, by extension, Health Level 7 (HL7) result messaging.\n\n\n\n24. Scientific data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASTM E1578-18 E-11-1\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.1 The system shall capture raw instrument data and metadata either as an electronic file or directly via RS-232 or TCP\/IP communication.\n\n\nASTM E1578-18 E-11-2\n\n24.2 The scientific data management system (SDMS) should provide a checksum verification of source and destination data and store that verification data in a secure server with controlled access.\n\n\n\nASTM E1578-18 E-11-1\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.3 The system shall store metadata related to raw instrument data in a database in such a way that the original data generated by instruments for specific samples and tests is easy to retrieve.\n\n\nASTM E1578-18 E-11-4\n\n24.4 The system should be capable of capturing a complete and readable copy of original data and any previous versions of modified data in order to maintain the integrity of that data.\n\n\n\nAAVLD AAVLD Requirements for an AVMDL Sec. 4.10.2.3\r\n\nASTM E1578-18 E-11-5\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.5 The system should secure raw data such that it can't be deleted and provide version control when data is modified by any user or specific software.\n\n\nASTM E1578-18 E-11-6\n\n24.6 The SDMS should provide tools for helping a laboratory achieve the U.S. Food and Drug Administration's defined ALCOA principles.\n\n\nASTM E1578-18 E-11-7\n\n24.7 The SDMS shall provide security and access controls for protecting stored data.\n\n\nASTM E1578-18 E-11-8\n\n24.8 The SDMS shall record an audit trail for each and every record created and modified, using version control.\n\n\n45 CFR Part 164.308\r\nASTM E1578-18 E-11-9\n\n24.9 The SDMS shall provide proper systems for backing up, restoring, and archiving data for long-term use.\n\n\n\n25. Health information technology \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n45 CFR Part 170.315 (a-1\u2013a-4)\n\n25.1 The electronic health record (EHR) module should provide computerized provider order entry (CPOE) functionality for medication orders, laboratory orders, and diagnostic imaging, including making checks for potential drug-drug and drug-allergy interactions.\n\n\n45 CFR Part 170.315 (a-5)\r\n45 CFR Part 170.315 (a-11\u2013a-12)\r\n45 CFR Part 170.315 (a-15)\n\n25.2 The EHR module should allow authorized personnel to record, change, and access patient demographic data, including, but not limited to, race and ethnicity, patient's preferred language, birth sex, current sex, sexual orientation, gender identity, birth date, smoking status, alcohol use, family health history, psychological aspects, social aspects, and behavioral aspects.\n\n\n45 CFR Part 170.315 (a-6\u2013a-8)\r\n45 CFR Part 170.315 (a-10)\r\n45 CFR Part 170.315 (a-14)\n\n25.3 The EHR module should allow authorized personnel to record, change, and access a patient's active problem list, medication list, medication allergy list, preferred drug list, and implantable device list, incorporating, where appropriate, at a minimum the SNOMED CT nomenclature standard.\n\n\n45 CFR Part 170.315 (a-19)\n\n25.4 The EHR module should incorporate configurable, role-based clinical decision support tools capable of allowing authorized personnel to trigger electronic interventions based on liked reference information standardized to Health Level 7 (HL7) Version 3 implementation guides. The reference information should be sourced.\n\n\n45 CFR Part 170.315 (a-13)\n\n25.5 The EHR module should be able to identify education resources specific to a patient's active problem and medication lists. The educational resources should be standardized to Health Level 7 (HL7) Version 3 implementation guides.\n\n\n45 CFR Part 170.315 (b-1\u2013b-2; b-4\u2013b-5)\n\n25.6 The EHR module should allow authorized personnel to create, view, send, and receive transition of care or referral summaries in such a way that the summary is properly formatted, matched to the correct patient, and reconciled according to the standards and protocols outlined in 45 CFR Part 170.315 (b-1), (b-2), (b-4), and (b-5).\n\n\n45 CFR Part 170.315 (b-3)\n\n25.7 The EHR module should allow authorized personnel to conduct electronic prescribing actions such as creating, changing, cancelling, and refilling prescriptions, incorporating at least the RxNorm and NCPDP SCRIPT standards.\n\n\n45 CFR Part 170.315 (b-6)\n\n25.8 The EHR module should allow authorized personnel to configure, create, and store data exports, incorporating at least HL7 Version 3 implementation standards, as well as SNOMED CT and ICD-9 standards.\n\n\n45 CFR Part 170.315 (b-7\u2013b-8)\n\n25.9 The EHR module should allow for the secure creation, sending, and receipt of restricted summary records, incorporating HL7 Version 3 implementation standards.\n\n\n45 CFR Part 170.315 (b-9)\n\n25.10 The EHR module should allow authorized personnel to create, record, change, access, and receive care plan information, incorporating HL7 Version 3 implementation standards.\n\n\n45 CFR Part 170.315 (c)\n\n25.11 The EHR module should provide a means to record, calculate, import, export, filter, and report on clinical quality measures according to the standards outlined in 45 CFR Part 170.315 (c).\n\n\n45 CFR Part 170.315 (d)\n\n25.12 The EHR module shall provide security and access controls for protecting stored data.\n\n\n45 CFR Part 170.315 (d)\n\n25.13 The EHR module shall record an audit trail for each and every record created and modified, using version control.\n\n\n45 CFR Part 170.315 (d-7)\n\n25.14 The EHR module shall either encrypt electronic health information on end-user devices after use of the technology on the device stops or prevent electronic health information from being stored on end-user devices after use of the technology on the device stops.\n\n\n45 CFR Part 170.315 (d-8)\n\n25.15 The EHR module shall ensure that electronically exchanged health information has not been altered during the transfer process, using at least a hashing algorithm secured to SHA-2 or better.\n\n\n45 CFR Part 170.315 (d-11)\n\n25.16 The EHR module should be capable of recording patient disclosures made for treatment, payment, and health care operations.\n\n\n45 CFR Part 170.315 (e-1)\n\n25.17 The EHR module should provide a means for patients and their authorized representatives to view, download, and transmit their personal health information and activity history log from the EHR via an internet-based technology, using the standards outlined in 45 CFR Part 170.315 (e-1).\n\n\n45 CFR Part 170.315 (e-2\u2013e-3)\n\n25.18 The EHR module should provide a means for authorized users to securely send messages to and receive messages from patients, at the same time allowing for the recording, accessing, and linking of information shared by the patient electronically (as well as directly).\n\n\n45 CFR Part 170.315 (f)\n\n25.19 The EHR module should allow vital patient information as it relates to public health to be transmitted to immunization registries, cancer registries, and public health agencies, as well as be accessed after the fact. This includes, but is not limited to, immunization history, surveillance information, laboratory test results, cancer case information, case reports, antimicrobial reporting, and health care survey information.\n\n\n45 CFR Part 170.315 (g-3\u2013g-5)\n\n25.20 The EHR developer should use user-centered and accessibility-centered design processes for creating and testing the EHR's functionality. A quality management system should be used during these processes.\n\n\n45 CFR Part 170.315 (g-6)\n\n25.21 The EHR module's use of clinical document architecture (CDA) should be demonstrated and verified for conformance to the standards identified in 45 CFR Part 170.315 (g-6).\n\n\n45 CFR Part 170.315 (g-7\u2013g-9)\n\n25.22 The EHR module should include an application programming interface (API) that demonstrates the EHR's ability to uniquely identify a patient and corresponding ID\/token in a received records or data category request in order to accurately and securely meet the request for that patient's data. The API should be well documented.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#24._Scientific_data_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#24._Scientific_data_management<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 2 May 2022, at 20:54.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2,200 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","b6db2dcdf3009db85f6affb0fff9d348_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Specialty_Laboratory_Functions rootpage-LII_LIMSpec_Specialty_Laboratory_Functions skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Specialty Laboratory Functions<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover the specialty requirements that come with working in specific industries such as agriculture, pharmaceutical production, and <a href=\"https:\/\/www.limswiki.org\/index.php\/Forensic_science\" title=\"Forensic science\" class=\"wiki-link\" data-key=\"415d36a7b65494677b6d2873d5febec1\">forensic science<\/a>. You'll likely notice that most of the content here isn't covered by <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a>.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"17._Production_management\">17. Production management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.103\" target=\"_blank\">21 CFR Part 211.103<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40 (d)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.4 and 16.20<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.1<\/b> The system should be able to calculate and record theoretical and actual percentage of yield at various phases of processing, manufacturing, and packaging.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.103\" target=\"_blank\">21 CFR Part 211.103<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.2<\/b> The system should provide a means for verification and approval of yield calculations before release for reporting.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.20\" target=\"_blank\">21 CFR Part 820.20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.186\" target=\"_blank\">21 CFR Part 820.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 1.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.3<\/b> The system shall be able to maintain a production facility's quality system in a specific quality system record, in accordance with regulations and guidance such as 21 CFR Part 820.20 and 820.40 (U.S.), E.U. Commission Directive 2003\/94\/EC Article 11 (E.U.), and WHO Technical Report Series, #986, Annex 2, 1.0 (global).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.30\" target=\"_blank\">21 CFR Part 820.30<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (e)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.4<\/b> The system shall be able to create a design control document capable of recording the details surrounding device development, including control number, physical and performance requirements, final output, review, verification, approval, transfer, changes, and complete design history.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.181\" target=\"_blank\">21 CFR Part 820.181<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.184\" target=\"_blank\">21 CFR Part 820.184<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.5<\/b> The system shall be able to create a device master and device history record capable of recording all information described in 21 CFR Part 820.181 and 820.184.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.255\u2013260<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.130\" target=\"_blank\">21 CFR Part 211.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.134\" target=\"_blank\">21 CFR Part 211.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.20\" target=\"_blank\">21 CFR Part 211.20 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.50\" target=\"_blank\">21 CFR Part 211.50 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.202\" target=\"_blank\">21 CFR Part 225.202<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.60\" target=\"_blank\">21 CFR Part 820.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 2 and 4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f\u2013g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.25\u201330<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.6<\/b> The system shall be able to create a batch production record capable of recording complete information regarding batch production and control details such as, but not limited to, a unique batch, lot, or production run number; formulation; specific labeling and packaging; production steps; in-process and laboratory control results; the unique identifier of any equipment used; persons performing and\/or supervising operational steps; and the results of any pre-process or post-production inspections.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.205\u2013210<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.186\" target=\"_blank\">21 CFR Part 211.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.22\u201323<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.7<\/b> The system shall be able to create a master production and control record capable of recording complete information regarding master production and control details.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.150 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.186\" target=\"_blank\">21 CFR Part 211.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 10.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.8<\/b> The system shall require a new or modified master production and control record to be validated, reviewed, and approved before being implemented into production, including allowing that record to be electronically signed by one or more authorized individuals upon approval. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.150 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.22\" target=\"_blank\">21 CFR Part 211.22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.75\" target=\"_blank\">21 CFR Part 820.75<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b, f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.9<\/b> The system shall require a new or modified production and control record to be validated, reviewed, and approved before being implemented in production. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 14.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.10<\/b> The system shall be able to indicate if a sample consists of an in-process manufacturing material and track characteristics of the in-process material such as identity, strength, quality, purity, and approval status.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.11<\/b> The system shall provide a means to track the amount of time between production processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (f-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c) and (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.60\" target=\"_blank\">21 CFR Part 820.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.5.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 14.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.32\u201333<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.12<\/b> The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, certificates of conformity, shelf life or expiration date, storage location, status of examination, and status of approval for use. Any related specifications for those materials should be able to be linked to the received materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.125\" target=\"_blank\">21 CFR Part 211.125 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.7 and 14.22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.35<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.13<\/b> The system shall be capable of recording the changing quantity of inventoried non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, labeling, containers, and packaging materials), including batch and lot numbers and, if applicable, details of disposition after completion of production.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.113<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.125\" target=\"_blank\">21 CFR Part 211.125 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (d\u2013e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.90\" target=\"_blank\">21 CFR Part 820.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.160\" target=\"_blank\">21 CFR Part 820.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 23<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.4, 14.26, and 14.28<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.44\u201345<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.36<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.18\u201319<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.14<\/b> The system shall prevent the internal release for distribution of a completed production batch until an authorized individual has determined the batch's conformance to final specifications and has approved it for release. If a batch is nonconforming, the system shall be able to clearly document it as such (so as to not distribute it) and provide a review and disposition process. Such approval, rejection, review, and disposition activities shall be documented.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\/subpart-C\" target=\"_blank\">21 CFR Part 7 Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.139<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.38<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\/subpart-B\" target=\"_blank\">21 CFR Part 810 Subpart B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 15.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 6.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.32<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.15<\/b> The system shall provide a means to track and record recall activities of manufactured product and devices based on lot, batch, or other identifier, including storage location, necessary disposition details, and reconciliation between distributed and recovered quantities.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.520<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.165\" target=\"_blank\">21 CFR Part 211.165 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.204\" target=\"_blank\">21 CFR Part 211.204<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.71\" target=\"_blank\">21 CFR Part 212.71 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.90\" target=\"_blank\">21 CFR Part 820.90 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.29\u201330<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.16<\/b> The system should allow a completed production batch that has been rejected for use or a returned production batch to be flagged in the system for reprocessing or reworking if it meets relevant criteria.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.145<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 4.11.8.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, I - FSM 19.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 11.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.17<\/b> The system shall support environmental testing protocols for testing the production environment on a scheduled, reportable basis. That support shall include facility and sampling site management functionality that allows for highlighting specific test points in the facility, as well as support for offsite and randomized testing. The system should also allow associated samples, methods, tests, reports, and other documents to clearly indicate they correspond to specific environmental testing protocols.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"18._Statistical_trending_and_control_charts\">18. Statistical trending and control charts<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.7.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-10-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>18.1<\/b> The system should allow authorized users to configure the generation of statistical trending and control charts.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.7.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-10-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>18.2<\/b> The system should allow authorized users to choose specific sample types, tests, and parameters associated with the statistical trending and control charts that can be generated.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"19._Agriculture_and_food_data_management\">19. Agriculture and food data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/orapartners.fda.gov\/cs\/groups\/public\/documents\/document\/b2hh\/bmri\/~edisp\/rpohandbook.pdf\" target=\"_blank\">FDA Office of Regulatory Affairs Data Exchange (ORA DX) Program<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.1<\/b> The system should be able to create or convert an XML or XLS file to ORA DX template specifications, including the use of ORA DX terminology.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.2<\/b> The system shall allow for the assignment of the \"regulatory sample collection\" role and be able to produce a list of individuals in said role, including information such as name, locations assigned, part- or full-time role, and full-time equivalents (if any) used to meet any regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.3<\/b> The system shall allow for the documentation of sampling sites used for normal and regulatory sampling and be able to produce a complete list of such sites on-demand. The documentation should allow for details such as the addition of a unique, never-before-used site code; a region code; demographics; date added to or removed from the system; facility type; sample substrates or commodities available at the site; and relative volume information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.4.12 and 5.4.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.4<\/b> The system shall allow a site that is no longer active for sampling purposes be designated as inactive, yet be allowed to remain on any generated master list. Additionally, such inactive site shall maintain its unique site number in the event the site becomes reinstated as active.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.130\u2013135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507, Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.2, 3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - HACCP 1.X<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 2.2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 2.2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>19.5<\/b> The system shall allow for the development and documentation of hazard analysis and critical control points (HACCP) or other regulatory-driven food safety plan steps, as well as the implementation of those CCPs or steps into configurable laboratory workflow.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.6<\/b> The system shall require a new or modified HACCP or other regulatory-driven food safety plan be validated, reviewed, and approved before being implemented, including requiring that plan to be electronically signed by one or more authorized individuals upon approval.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.92<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>19.7<\/b> The system shall allow for the documentation and management of internal and external audit activities, while allowing samples, methods, tests, results, reports, documents, and more to be clearly associated with that corresponding audit activity.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"20._Environmental_data_management\">20. Environmental data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/geospatial\/epa-metadata-technical-specification\" target=\"_blank\">EPA Metadata Technical Specification<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.1<\/b> The system should support metadata requirements set forth by ISO 19115 and the EPA Metadata Technical Specification for reporting and data publishing purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.2<\/b> The system should support the manual entry or electronic transfer of EPA analytical service requests (ASRs), along with all the required fields of the ASR, including project identifier, project demographics, sample specifics, sample hazards, reporting requirements, and special requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/2015-07\/documents\/sedd52_specification.pdf\" target=\"_blank\">EPA SEDD Specification and Data Element Dictionary v5.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.3<\/b> The system should support the creation and transfer of Staged Electronic Data Deliverable (SEDD) files.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.10\" target=\"_blank\">40 CFR Part 3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/60\" target=\"_blank\">40 CFR Part 60 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/62\" target=\"_blank\">40 CFR Part 62 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/63\" target=\"_blank\">40 CFR Part 63 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>20.4<\/b> The system shall support generating electronic environmental reports (e.g., stationary source emissions tests) in either the EPA's Electronic Reporting Tool (ERT) special spreadsheet format or in an XML file format that complies with EPA-approved XML schema.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/denix.osd.mil\/edqw\/documents\/documents\/gen-data-validation-rev1\/\" target=\"_blank\">DoD General Data Validation Guidelines<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.5<\/b> The system should support electronic data deliverable (EDD) validation by linking the EDD to its quality assurance project plan (QAPP) and the appropriate stage of validation for the EDD's data type.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"21._Forensic_case_and_data_management\">21. Forensic case and data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.4.3<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1459-13 2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 4.1.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 4.1.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 4.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.1<\/b> The system shall be able to assign each piece of collected evidence and each scene a unique identifier using methodologies such as an ID with an incrementing integer (for sequential evidence numbers) or a user-defined naming format for meeting regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.6\u201310<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.2<\/b> The system shall be able to assign each case a unique case identifier that, in addition to an electronic signature, is able to be automatically placed on, at a maximum, each page of the case's associated examination and administration records.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.5.1.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.3<\/b> In addition to a unique case number, the system shall provide a means to add additional information to a case file, including, but not limited to, submitting agency, agency case number, date of case receipt, name of recipient, shipping and receipt details, items associated with the case and their unique designators, notes, test data, related reports, and other documentation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 (throughout)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 (throughout)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.4.3 and 4.5.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.4<\/b> The system should be able to document evidence using an ASTM-compliant evidence log, including, but not limited to, unique identifiers, investigator and custodian names, key dates and times, evidence conditions, and storage location.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.1.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.5<\/b> The system should be able to prevent a piece of evidence from being scheduled for destructive testing until an appropriate authorization for such analysis is acquired and documented.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.6<\/b> The system shall be able to record and maintain chain of custody of evidence that is subdivided in the laboratory in the same way that original evidence items are tracked.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.1.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.7<\/b> The system shall be capable of recording the secondary dissemination to an authorized agency or organization of criminal history record information (CHRI) sourced from U.S. Criminal Justice Information Services (CJIS).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.8<\/b> The system shall be able to record all National Crime Information Center (NCIC) and Interstate Identification Index (III) data transactions, clearly identifying the operator and authorized receiving agency or organization. III records shall also identify requester and recipient using a unique identifier.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(1) <\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.9<\/b> If the system provides remote access to authorized users over authorized devices, the remote access shall be monitored, controlled and documented, particularly for privileged functions. If remote access to privileged functions is allowed, virtual escorting that meets CJIS Security Policy 5.5.6 conditions will be required.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.1.1.1\u20132<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.1.2\u20133<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5(1) <\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.10<\/b> The system shall be capable of putting into place, in their entirety, either the \"basic password standards\" or \"advanced password standards\" described in CJIS Security Policy 5.6.2.1.1.1 and 5.6.2.1.1.2. If PIN and\/or one-time password is also used, the attributes in 5.6.2.1.2 and 5.6.2.1.3 shall also be required.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.11<\/b> If the system supports user-based certificates for authentication, the system shall be configurable enough to require them to be 1. user-specific, not device-specific, 2. used only by one user at any given time, and 3. activated for each use by, e.g., a passphrase or PIN.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2.1\u20132<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(2) <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-13, SC-28, and SC-28(1)<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.12<\/b> The system shall allow \"encryption in transit\" and \"encryption at rest\" of criminal justice information (CJI) that meets or exceeds the requirements of CJIS Security Policy 5.10.1.2.1 and 5.10.1.2.2.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.13<\/b> If the system is cloud-based, the vendor shall ensure that CJI is stored in databases located within the physical boundaries of APB-member countries and within the legal authority of APB-member agencies. Additionally, the vendor shall agree to not use any metadata derived from unencrypted CJI for commercial, advertising, or other purposes, unless specifically permitted for limited within the service agreement.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.11.1\u20132<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.14<\/b> If the system is cloud-based, the vendor should agree to FBI and CSA compliance and security audits of CJI.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.3.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.15<\/b> If the system is capable of being run in a virtual environment, it shall meet the virtualization requirements set forth in CJIS Security Policy 5.10.3.2 and best practices set forth in CJIS Security Policy Appendix G.1.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6(4)<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-39<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.16<\/b> The system should provide separate processing domains in order to not only allow for more granular allocation of user privileges, but also to prevent one process from modifying the executing code of another process.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2(1\u20132), IA-2(12), and IA-8(1)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.17<\/b> The system should support the use of personal identity verification\u2014a U.S. Federal government-wide credential system\u2014and other forms of hardware-based (i.e., public key infrastructure or PKI) token authentication, while electronically verifying those credentials and any configured token quality requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.18<\/b> The system should support the identification and tagging of infrequently performed forensic tests or analyses in order to alert the analyst and other stakeholders that additional competency verification or method validation is required before performing the test or analysis.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.19<\/b> The system should allow case records to be scheduled for periodic administrative and technical review by individuals not connected with the case. The conducted review should indicate details such as who conducted the review, what the results were, and when the review was completed. If non-conforming results were discovered, records of determination and resolution should be appended to the case record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.20<\/b> The system should be able to document examiner testimony and allow such testimony to be scheduled for periodic evaluation. The conducted evaluation should indicate details such as who conducted the evaluation, what the results were, and when the review was completed. If non-conforming results were discovered, related records of determination and resolution should be maintained in the system.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"22._Clinical_and_public_health_data_management\">22. Clinical and public health data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/phin\/tools\/phinms\/index.html\" target=\"_blank\">CDC PHIN Messaging System<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.1<\/b> The system should be capable of interfacing with the Center for Disease Control and Prevention's PHIN Messaging System.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.5<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>22.2<\/b> The system should support Human Genome Variation Society (HGVS) nomenclature and terminology for sequence variants.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.3<\/b> The system should be able to collect sufficient test utilization information to make necessity checks on ordered tests against established benchmarks.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healthit.gov\/isa\/united-states-core-data-interoperability-uscdi\" target=\"_blank\">ONC USCDI v2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.4<\/b> The system should support the United States Core Data for Interoperability (USCDI) v2 standard, which in turn supports data interoperability across multiple clinical settings.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"23._Veterinary_data_management\">23. Veterinary data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphis.usda.gov\/aphis\/ourfocus\/animalhealth\/lab-info-services\/nahln\/ct_nahln_it\" target=\"_blank\">NAHLN Information Technology System<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/venomcoding.org\/\" target=\"_blank\">VeNom Coding Group<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vtsl.vetmed.vt.edu\/\" target=\"_blank\">Veterinary Terminology Services Laboratory<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.1<\/b> The system should support standardized veterinary clinical terminology such as that found in the Veterinary Extension of SNOMED CT and the Veterinary Nomenclature (VeNom) Codes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.icar.org\/Guidelines\/15-Data-Exchange.pdf\" target=\"_blank\">ICAR 15 Data Exchange<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vichsec.org\/en\/guidelines\/general\" target=\"_blank\">VICH GL53<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.2<\/b> The system should be able to exchange data, when necessary, in a fashion that meets International Committee for Animal Recording (ICAR) and Veterinary International Conference on Harmonization (VICH) electronic data exchange guidelines.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphis.usda.gov\/animal_health\/nahln\/downloads\/MessagingQuickGuide.pdf\" target=\"_blank\">NAHLN HL7 Messaging Quick User Guide<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.3<\/b> The system should support National Animal Health Laboratory Network (NAHLN), and, by extension, Health Level 7 (HL7) result messaging.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"24._Scientific_data_management\">24. Scientific data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.1<\/b> The system shall capture raw instrument data and metadata either as an electronic file or directly via RS-232 or TCP\/IP communication.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.2<\/b> The scientific data management system (SDMS) should provide a checksum verification of source and destination data and store that verification data in a secure server with controlled access.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.3<\/b> The system shall store metadata related to raw instrument data in a database in such a way that the original data generated by instruments for specific samples and tests is easy to retrieve.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.4<\/b> The system should be capable of capturing a complete and readable copy of original data and any previous versions of modified data in order to maintain the integrity of that data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD AAVLD Requirements for an AVMDL Sec. 4.10.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.5<\/b> The system should secure raw data such that it can't be deleted and provide version control when data is modified by any user or specific software.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.6<\/b> The SDMS should provide tools for helping a laboratory achieve the U.S. Food and Drug Administration's defined ALCOA principles.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.7<\/b> The SDMS shall provide security and access controls for protecting stored data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.8<\/b> The SDMS shall record an audit trail for each and every record created and modified, using version control.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.9<\/b> The SDMS shall provide proper systems for backing up, restoring, and archiving data for long-term use.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"25._Health_information_technology\">25. Health information technology<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-1\u2013a-4)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.1<\/b> The electronic health record (EHR) module should provide computerized provider order entry (CPOE) functionality for medication orders, laboratory orders, and diagnostic imaging, including making checks for potential drug-drug and drug-allergy interactions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-5)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-11\u2013a-12)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-15)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.2<\/b> The EHR module should allow authorized personnel to record, change, and access patient demographic data, including, but not limited to, race and ethnicity, patient's preferred language, birth sex, current sex, sexual orientation, gender identity, birth date, smoking status, alcohol use, family health history, psychological aspects, social aspects, and behavioral aspects.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-6\u2013a-8)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-10)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-14)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.3<\/b> The EHR module should allow authorized personnel to record, change, and access a patient's active problem list, medication list, medication allergy list, preferred drug list, and implantable device list, incorporating, where appropriate, at a minimum the SNOMED CT nomenclature standard.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-19)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.4<\/b> The EHR module should incorporate configurable, role-based clinical decision support tools capable of allowing authorized personnel to trigger electronic interventions based on liked reference information standardized to Health Level 7 (HL7) Version 3 implementation guides. The reference information should be sourced.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-13)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.5<\/b> The EHR module should be able to identify education resources specific to a patient's active problem and medication lists. The educational resources should be standardized to Health Level 7 (HL7) Version 3 implementation guides.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-1\u2013b-2; b-4\u2013b-5)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.6<\/b> The EHR module should allow authorized personnel to create, view, send, and receive transition of care or referral summaries in such a way that the summary is properly formatted, matched to the correct patient, and reconciled according to the standards and protocols outlined in 45 CFR Part 170.315 (b-1), (b-2), (b-4), and (b-5).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.7<\/b> The EHR module should allow authorized personnel to conduct electronic prescribing actions such as creating, changing, cancelling, and refilling prescriptions, incorporating at least the RxNorm and NCPDP SCRIPT standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-6)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.8<\/b> The EHR module should allow authorized personnel to configure, create, and store data exports, incorporating at least HL7 Version 3 implementation standards, as well as SNOMED CT and ICD-9 standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-7\u2013b-8)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.9<\/b> The EHR module should allow for the secure creation, sending, and receipt of restricted summary records, incorporating HL7 Version 3 implementation standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-9)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.10<\/b> The EHR module should allow authorized personnel to create, record, change, access, and receive care plan information, incorporating HL7 Version 3 implementation standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (c)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.11<\/b> The EHR module should provide a means to record, calculate, import, export, filter, and report on clinical quality measures according to the standards outlined in 45 CFR Part 170.315 (c).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.12<\/b> The EHR module shall provide security and access controls for protecting stored data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.13<\/b> The EHR module shall record an audit trail for each and every record created and modified, using version control.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.14<\/b> The EHR module shall either encrypt electronic health information on end-user devices after use of the technology on the device stops or prevent electronic health information from being stored on end-user devices after use of the technology on the device stops.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-8)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.15<\/b> The EHR module shall ensure that electronically exchanged health information has not been altered during the transfer process, using at least a hashing algorithm secured to SHA-2 or better.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-11)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.16<\/b> The EHR module should be capable of recording patient disclosures made for treatment, payment, and health care operations.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (e-1)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.17<\/b> The EHR module should provide a means for patients and their authorized representatives to view, download, and transmit their personal health information and activity history log from the EHR via an internet-based technology, using the standards outlined in 45 CFR Part 170.315 (e-1).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (e-2\u2013e-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.18<\/b> The EHR module should provide a means for authorized users to securely send messages to and receive messages from patients, at the same time allowing for the recording, accessing, and linking of information shared by the patient electronically (as well as directly).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (f)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.19<\/b> The EHR module should allow vital patient information as it relates to public health to be transmitted to immunization registries, cancer registries, and public health agencies, as well as be accessed after the fact. This includes, but is not limited to, immunization history, surveillance information, laboratory test results, cancer case information, case reports, antimicrobial reporting, and health care survey information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-3\u2013g-5)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.20<\/b> The EHR developer should use user-centered and accessibility-centered design processes for creating and testing the EHR's functionality. A quality management system should be used during these processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-6)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.21<\/b> The EHR module's use of clinical document architecture (CDA) should be demonstrated and verified for conformance to the standards identified in 45 CFR Part 170.315 (g-6).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-7\u2013g-9)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.22<\/b> The EHR module should include an application programming interface (API) that demonstrates the EHR's ability to uniquely identify a patient and corresponding ID\/token in a received records or data category request in order to accurately and securely meet the request for that patient's data. The API should be well documented.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173544\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.091 seconds\nReal time usage: 0.100 seconds\nPreprocessor visited node count: 377\/1000000\nPost\u2010expand include size: 77243\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 20.131 1 -total\n 12.96% 2.609 1 Template:LIMSpec\/Production_management\n 11.73% 2.361 1 Template:LIMSpec\/Environmental_data_management\n 11.17% 2.248 1 Template:LIMSpec\/Veterinary_data_management\n 11.10% 2.234 1 Template:LIMSpec\/Health_information_technology\n 10.88% 2.191 1 Template:LIMSpec\/Scientific_data_management\n 9.85% 1.984 1 Template:LIMSpec\/Public_health_data_management\n 9.80% 1.973 1 Template:LIMSpec\/Forensic_case_and_data_management\n 9.37% 1.887 1 Template:LIMSpec\/Agriculture_and_food_data_management\n 9.11% 1.833 1 Template:LIMSpec\/Statistical_trending_and_control_charts\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11203-0!canonical and timestamp 20221202173544 and revision id 47561. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#24._Scientific_data_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#24._Scientific_data_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","b6db2dcdf3009db85f6affb0fff9d348_images":[],"b6db2dcdf3009db85f6affb0fff9d348_timestamp":1670002545,"358bde209d8d7ca4c22ace38b7fe75b4_type":"article","358bde209d8d7ca4c22ace38b7fe75b4_title":"23. Veterinary data management","358bde209d8d7ca4c22ace38b7fe75b4_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#23._Veterinary_data_management","358bde209d8d7ca4c22ace38b7fe75b4_plaintext":"\n\nLII:LIMSpec\/Specialty Laboratory FunctionsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover the specialty requirements that come with working in specific industries such as agriculture, pharmaceutical production, and forensic science. You'll likely notice that most of the content here isn't covered by ASTM E1578-18.\n\n17. Production management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 211.103\r\n21 CFR Part 226.40 (d)\r\nWHO Technical Report Series, #986, Annex 2, 16.4 and 16.20\n\n17.1 The system should be able to calculate and record theoretical and actual percentage of yield at various phases of processing, manufacturing, and packaging.\n\n\n21 CFR Part 211.103\n\n17.2 The system should provide a means for verification and approval of yield calculations before release for reporting.\n\n\n\n21 CFR Part 820.20\r\n\n21 CFR Part 820.40\r\n\n21 CFR Part 820.186\r\n\nE.U. Commission Directive 2003\/94\/EC Article 11\r\n\nWHO Technical Report Series, #986, Annex 2, 1.0\n\n\n17.3 The system shall be able to maintain a production facility's quality system in a specific quality system record, in accordance with regulations and guidance such as 21 CFR Part 820.20 and 820.40 (U.S.), E.U. Commission Directive 2003\/94\/EC Article 11 (E.U.), and WHO Technical Report Series, #986, Annex 2, 1.0 (global).\n\n\n21 CFR Part 820.30\r\n21 CFR Part 820.120 (e)\n\n17.4 The system shall be able to create a design control document capable of recording the details surrounding device development, including control number, physical and performance requirements, final output, review, verification, approval, transfer, changes, and complete design history.\n\n\n21 CFR Part 820.181\r\n21 CFR Part 820.184\n\n17.5 The system shall be able to create a device master and device history record capable of recording all information described in 21 CFR Part 820.181 and 820.184.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 111.255\u2013260\r\n\n21 CFR Part 114.100 (b)\r\n\n21 CFR Part 211.105 (b)\r\n\n21 CFR Part 211.130 (e)\r\n\n21 CFR Part 211.134 (c)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.20 (d)\r\n\n21 CFR Part 211.50 (c)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 225.202\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 820.60\r\n\n21 CFR Part 820.70 (a)\r\n\n21 CFR Part 820.80 (c)\r\n\n21 CFR Part 820.120 (d)\r\n\nBRC GSFS, Issue 8, 6.1.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.1.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 8.1\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.1\r\n\nFDA Hazard Analysis Critical Control Point Principle 2 and 4\r\n\nFDA Hazard Analysis Critical Control Point Principle 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11\r\n\nIFS Food 7, Part 2, 4.2.1.1\r\n\nIFS Food 7, Part 2, 4.18.1\r\n\nIFS PACsecure 2, Part 2, 4.2.1.1\r\n\nIFS PACsecure 2, Part 2, 4.18.1\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (3)\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f\u2013g)\r\n\nWHO Technical Report Series, #986, Annex 2, 15.25\u201330\n\n\n17.6 The system shall be able to create a batch production record capable of recording complete information regarding batch production and control details such as, but not limited to, a unique batch, lot, or production run number; formulation; specific labeling and packaging; production steps; in-process and laboratory control results; the unique identifier of any equipment used; persons performing and\/or supervising operational steps; and the results of any pre-process or post-production inspections.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.100 (e)\r\n\n21 CFR Part 111.205\u2013210\r\n\n21 CFR Part 114.100 (b)\r\n\n21 CFR Part 211.186\r\n\n21 CFR Part 212.50 (b)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nBRC GSFS, Issue 8, 3.6.2\r\n\nBRC GSFS, Issue 8, 9.2.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.1.2\r\n\nFDA Hazard Analysis Critical Control Point Principle 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11\r\n\nIFS Food 7, Part 2, 4.2.1.1\r\n\nIFS PACsecure 2, Part 2, 4.2.1.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 15.22\u201323\n\n\n17.7 The system shall be able to create a master production and control record capable of recording complete information regarding master production and control details.\n\n\n\n21 CFR Part 106.100 (e)\r\n\n21 CFR Part 111.123 (a)\r\n\n21 CFR Part 114.100 (c)\r\n\n21 CFR Part 117.150 (d)\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.186\r\n\n21 CFR Part 212.50 (b)\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nBRC GSFS, Issue 8, 9.2.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 10.3\u20134\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.2\r\n\nIFS Food 7, Part 2, 4.2.1.2\r\n\nIFS Food 7, Part 2, 4.3.x\r\n\nIFS Food 7, Part 2, 5.11\r\n\nIFS PACsecure 2, Part 2, 4.2.1.2\r\n\nIFS PACsecure 2, Part 2, 4.3.x\r\n\nIFS PACsecure 2, Part 2, 5.11\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b)\r\n\nWHO Technical Report Series, #986, Annex 2, 4.0\n\n\n17.8 The system shall require a new or modified master production and control record to be validated, reviewed, and approved before being implemented into production, including allowing that record to be electronically signed by one or more authorized individuals upon approval. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n\n\n\n21 CFR Part 111.123 (a)\r\n\n21 CFR Part 114.100 (c)\r\n\n21 CFR Part 117.150 (d)\r\n\n21 CFR Part 211.22\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 820.70 (b)\r\n\n21 CFR Part 820.75\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 10.3\r\n\nIFS Food 7, Part 2, 4.2.1.2\r\n\nIFS Food 7, Part 2, 4.3.x\r\n\nIFS Food 7, Part 2, 5.11\r\n\nIFS PACsecure 2, Part 2, 4.2.1.2\r\n\nIFS PACsecure 2, Part 2, 4.3.x\r\n\nIFS PACsecure 2, Part 2, 5.11\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b, f)\r\n\nWHO Technical Report Series, #986, Annex 2, 4.0\n\n\n17.9 The system shall require a new or modified production and control record to be validated, reviewed, and approved before being implemented in production. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n\n\n\n21 CFR Part 211.110\r\n\n21 CFR Part 212.50\r\n\n21 CFR Part 820.80 (c)\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\r\n\nISO\/TS 22002-1:2009, 14.3\n\n\n17.10 The system shall be able to indicate if a sample consists of an in-process manufacturing material and track characteristics of the in-process material such as identity, strength, quality, purity, and approval status.\n\n\n21 CFR Part 211.111\n\n17.11 The system shall provide a means to track the amount of time between production processes.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.80\r\n\n21 CFR Part 106.100 (f-6)\r\n\n21 CFR Part 117.420\r\n\n21 CFR Part 211.122 (c)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 212.20 (b)\r\n\n21 CFR Part 212.40 (c) and (e)\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.40 (b)\r\n\n21 CFR Part 226.42\r\n\n21 CFR Part 606.120 (b)\r\n\n21 CFR Part 820.60\r\n\n21 CFR Part 820.80 (b)\r\n\n21 CFR Part 820.120 (b)\r\n\nBRC GSFS, Issue 8, 3.6.1\r\n\nBRC GSFS, Issue 8, 3.9.2\r\n\nBRC GSFS, Issue 8, 5.4.4\r\n\nBRC GSFS, Issue 8, 3.5.1\r\n\nBRC GSFS, Issue 8, 9.5.1\u20132\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17\r\n\nIFS Food 7, Part 2, 4.5.2\r\n\nIFS Food 7, Part 2, 4.18.1\r\n\nIFS PACsecure 2, Part 2, 4.5.2\r\n\nIFS PACsecure 2, Part 2, 4.18.1\r\n\nISO\/TS 22002-1:2009, 9.3\r\n\nISO\/TS 22002-1:2009, 14.2\r\n\nISO\/TS 22002-4:2013, 4.6.3\r\n\nISO\/TS 22002-4:2013, 4.11.2\r\n\nISO\/TS 22002-6:2016, 4.6.3\r\n\nISO\/TS 22002-6:2016, 4.11.2\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nWHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21\r\n\nWHO Technical Report Series, #986, Annex 2, 15.32\u201333\n\n\n17.12 The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, certificates of conformity, shelf life or expiration date, storage location, status of examination, and status of approval for use. Any related specifications for those materials should be able to be linked to the received materials.\n\n\n\n21 CFR Part 211.122 (e)\r\n\n21 CFR Part 211.125 (d)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.42\r\n\nBRC GSFS, Issue 8, 3.5.3\r\n\nBRC GSFS, Issue 8, 9.5.3\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17\r\n\nWHO Technical Report Series, #986, Annex 2, 14.7 and 14.22\r\n\nWHO Technical Report Series, #986, Annex 2, 16.35\n\n\n17.13 The system shall be capable of recording the changing quantity of inventoried non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, labeling, containers, and packaging materials), including batch and lot numbers and, if applicable, details of disposition after completion of production.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.70\r\n\n21 CFR Part 111.113\r\n\n21 CFR Part 111.123 (b)\r\n\n21 CFR Part 114.100 (d)\r\n\n21 CFR Part 120.10\r\n\n21 CFR Part 123.6\r\n\n21 CFR Part 211.122 (e)\r\n\n21 CFR Part 211.125 (d)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.42\r\n\n21 CFR Part 606.100 (c)\r\n\n21 CFR Part 820.80 (d\u2013e)\r\n\n21 CFR Part 820.90\r\n\n21 CFR Part 820.160\r\n\nBRC GSFS, Issue 8, 3.8.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.2\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 23\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\nIFS Food 7, Part 2, 5.7.1\r\n\nIFS Food 7, Part 2, 5.10\r\n\nIFS PACsecure 2, Part 2, 5.7.1\r\n\nIFS PACsecure 2, Part 2, 5.10\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.5\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.7\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.5\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.7\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.5\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.7\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (g)\r\n\nWHO Technical Report Series, #986, Annex 2, 14.4, 14.26, and 14.28\r\n\nWHO Technical Report Series, #986, Annex 2, 15.44\u201345\r\n\nWHO Technical Report Series, #986, Annex 2, 16.36\r\n\nWHO Technical Report Series, #986, Annex 2, 17.18\u201319\n\n\n17.14 The system shall prevent the internal release for distribution of a completed production batch until an authorized individual has determined the batch's conformance to final specifications and has approved it for release. If a batch is nonconforming, the system shall be able to clearly document it as such (so as to not distribute it) and provide a review and disposition process. Such approval, rejection, review, and disposition activities shall be documented.\n\n\n\n21 CFR Part 7 Subpart C\r\n\n21 CFR Part 117.139\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 507.38\r\n\n21 CFR Part 810 Subpart B\r\n\nBRC GSFS, Issue 8, 3.11.2\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.5\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\nIFS Food 7, Part 2, 5.9.2\r\n\nIFS PACsecure 2, Part 2, 5.9.2\r\n\nISO\/TS 22002-1:2009, 15.x\r\n\nISO\/TS 22002-4:2013, 4.12\r\n\nISO\/TS 22002-6:2016, 4.12\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.6.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.6.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.3\r\n\nWHO Technical Report Series, #986, Annex 2, 6.0\r\n\nWHO Technical Report Series, #986, Annex 2, 14.32\n\n\n17.15 The system shall provide a means to track and record recall activities of manufactured product and devices based on lot, batch, or other identifier, including storage location, necessary disposition details, and reconciliation between distributed and recovered quantities.\n\n\n\n21 CFR Part 111.520\r\n\n21 CFR Part 211.165 (f)\r\n\n21 CFR Part 211.204\r\n\n21 CFR Part 212.71 (d)\r\n\n21 CFR Part 820.90 (b-2)\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.6\r\n\nWHO Technical Report Series, #986, Annex 2, 14.29\u201330\n\n\n17.16 The system should allow a completed production batch that has been rejected for use or a returned production batch to be flagged in the system for reprocessing or reworking if it meets relevant criteria.\n\n\n\n21 CFR Part 112.145\r\n\nBRC GSFS, Issue 8, 4.11.8.x\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, I - FSM 19.2\r\n\nISO\/TS 22002-1:2009, 11.5\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.8\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.8\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.8\n\n\n17.17 The system shall support environmental testing protocols for testing the production environment on a scheduled, reportable basis. That support shall include facility and sampling site management functionality that allows for highlighting specific test points in the facility, as well as support for offsite and randomized testing. The system should also allow associated samples, methods, tests, reports, and other documents to clearly indicate they correspond to specific environmental testing protocols.\n\n\n\n18. Statistical trending and control charts \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 820.250\r\n\nAIHA-LAP Policies 2018 2A.7.7.1.3\r\n\nASTM E1578-18 E-10-1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7.2.8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.8\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 9\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\n\n\n18.1 The system should allow authorized users to configure the generation of statistical trending and control charts.\n\n\n\n21 CFR Part 820.250\r\n\nAIHA-LAP Policies 2018 2A.7.7.1.3\r\n\nASTM E1578-18 E-10-2\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7.2.8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.8\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 9\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\n\n\n18.2 The system should allow authorized users to choose specific sample types, tests, and parameters associated with the statistical trending and control charts that can be generated.\n\n\n\n19. Agriculture and food data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nFDA Office of Regulatory Affairs Data Exchange (ORA DX) Program\n\n19.1 The system should be able to create or convert an XML or XLS file to ORA DX template specifications, including the use of ORA DX terminology.\n\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\nUSDA Sampling Procedures for PDP 5.3\r\nUSDA Sampling Procedures for PDP 6.2\n\n19.2 The system shall allow for the assignment of the \"regulatory sample collection\" role and be able to produce a list of individuals in said role, including information such as name, locations assigned, part- or full-time role, and full-time equivalents (if any) used to meet any regulatory requirements.\n\n\nUSDA Sampling Procedures for PDP 5.4\n\n19.3 The system shall allow for the documentation of sampling sites used for normal and regulatory sampling and be able to produce a complete list of such sites on-demand. The documentation should allow for details such as the addition of a unique, never-before-used site code; a region code; demographics; date added to or removed from the system; facility type; sample substrates or commodities available at the site; and relative volume information.\n\n\nUSDA Sampling Procedures for PDP 5.4.12 and 5.4.14\n\n19.4 The system shall allow a site that is no longer active for sampling purposes be designated as inactive, yet be allowed to remain on any generated master list. Additionally, such inactive site shall maintain its unique site number in the event the site becomes reinstated as active.\n\n\n\n21 CFR Part 117.130\u2013135\r\n\n21 CFR Part 120 (throughout)\r\n\n21 CFR Part 123.6\r\n\n21 CFR Part 507, Subpart C\r\n\n61 FR 38806, 9 CFR Part 417.x\r\n\nBRC GSFS, Issue 8, 2.x\r\n\nCodex Alimentarius CXC 1-1969, Ch.2, 3.x\r\n\nE.U. Commission Reg. No. 852\/2004 Article 5\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - HACCP 1.X\r\n\nIFS Food 7, Part 2, 2.2.x\r\n\nIFS PACsecure 2, Part 2, 2.2.x\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.3\n\n\n19.5 The system shall allow for the development and documentation of hazard analysis and critical control points (HACCP) or other regulatory-driven food safety plan steps, as well as the implementation of those CCPs or steps into configurable laboratory workflow.\n\n\n61 FR 38806, 9 CFR Part 417.4\n\n19.6 The system shall require a new or modified HACCP or other regulatory-driven food safety plan be validated, reviewed, and approved before being implemented, including requiring that plan to be electronically signed by one or more authorized individuals upon approval.\n\n\n\n21 CFR Part 106.90\r\n\n21 CFR Part 106.92\r\n\n21 CFR Part 106.94\r\n\n21 CFR Part 106.100 (j)\r\n\nBRC GSFS, Issue 8, 3.4.x\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 20\r\n\nIFS Food 7, Part 2, 5.1\r\n\nIFS PACsecure 2, Part 2, 5.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.4\n\n\n19.7 The system shall allow for the documentation and management of internal and external audit activities, while allowing samples, methods, tests, results, reports, documents, and more to be clearly associated with that corresponding audit activity.\n\n\n\n20. Environmental data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nEPA Metadata Technical Specification\n\n20.1 The system should support metadata requirements set forth by ISO 19115 and the EPA Metadata Technical Specification for reporting and data publishing purposes.\n\n\nEPA ERLN Laboratory Requirements 3.3\n\n20.2 The system should support the manual entry or electronic transfer of EPA analytical service requests (ASRs), along with all the required fields of the ASR, including project identifier, project demographics, sample specifics, sample hazards, reporting requirements, and special requirements.\n\n\nEPA SEDD Specification and Data Element Dictionary v5.2\n\n20.3 The system should support the creation and transfer of Staged Electronic Data Deliverable (SEDD) files.\n\n\n\n40 CFR Part 3.10\r\n\n40 CFR Part 60 (throughout)\r\n\n40 CFR Part 62 (throughout)\r\n\n40 CFR Part 63 (throughout)\n\n\n20.4 The system shall support generating electronic environmental reports (e.g., stationary source emissions tests) in either the EPA's Electronic Reporting Tool (ERT) special spreadsheet format or in an XML file format that complies with EPA-approved XML schema.\n\n\nDoD General Data Validation Guidelines\n\n20.5 The system should support electronic data deliverable (EDD) validation by linking the EDD to its quality assurance project plan (QAPP) and the appropriate stage of validation for the EDD's data type.\n\n\n\n21. Forensic case and data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.4.3\nASTM E1188-11 3.2.3\r\n\nASTM E1188-11 3.4.1\r\n\nASTM E1459-13 2.1\r\n\nASTM E1459-13 4.1.1\u20132\r\n\nASTM E1459-13 4.1.4.2\r\n\nASTM E1459-13 4.2.2\u20133\r\n\nASTM E1492-11 4.1.1\r\n\nASTM E1492-11 4.1.5\n\n\n21.1 The system shall be able to assign each piece of collected evidence and each scene a unique identifier using methodologies such as an ID with an incrementing integer (for sequential evidence numbers) or a user-defined naming format for meeting regulatory requirements.\n\n\nA2LA C223 4.13\r\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.6\u201310\r\nASTM E1492-11 4.1.1\r\n\n\n21.2 The system shall be able to assign each case a unique case identifier that, in addition to an electronic signature, is able to be automatically placed on, at a maximum, each page of the case's associated examination and administration records.\n\n\n\nA2LA C223 4.13\r\n\nASTM E1492-11 4.1.1.1\u20132\r\n\nASTM E1492-11 4.1.4\u20135\r\n\nASTM E1492-11 4.2.2\u20133\r\n\nASTM E1492-11 4.5.1.1\n\n\n21.3 In addition to a unique case number, the system shall provide a means to add additional information to a case file, including, but not limited to, submitting agency, agency case number, date of case receipt, name of recipient, shipping and receipt details, items associated with the case and their unique designators, notes, test data, related reports, and other documentation.\n\n\nASTM E1188-11 (throughout)\r\nASTM E1459-13 (throughout)\r\nASTM E1492-11 4.4.3 and 4.5.1\n\n21.4 The system should be able to document evidence using an ASTM-compliant evidence log, including, but not limited to, unique identifiers, investigator and custodian names, key dates and times, evidence conditions, and storage location.\n\n\nASTM E1492-11 4.3.1.1\n\n21.5 The system should be able to prevent a piece of evidence from being scheduled for destructive testing until an appropriate authorization for such analysis is acquired and documented.\n\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1.1\r\nASTM E1492-11 4.1.2\n\n21.6 The system shall be able to record and maintain chain of custody of evidence that is subdivided in the laboratory in the same way that original evidence items are tracked.\n\n\nCJIS Security Policy 5.1.3\n\n21.7 The system shall be capable of recording the secondary dissemination to an authorized agency or organization of criminal history record information (CHRI) sourced from U.S. Criminal Justice Information Services (CJIS).\n\n\nCJIS Security Policy 5.4.7\n\n21.8 The system shall be able to record all National Crime Information Center (NCIC) and Interstate Identification Index (III) data transactions, clearly identifying the operator and authorized receiving agency or organization. III records shall also identify requester and recipient using a unique identifier.\n\n\nCJIS Security Policy 5.5.6\r\nNIST 800-53, Rev. 5, AC-17(1) \r\n\n\n21.9 If the system provides remote access to authorized users over authorized devices, the remote access shall be monitored, controlled and documented, particularly for privileged functions. If remote access to privileged functions is allowed, virtual escorting that meets CJIS Security Policy 5.5.6 conditions will be required.\n\n\nCJIS Security Policy 5.6.2.1.1.1\u20132\r\nCJIS Security Policy 5.6.2.1.2\u20133\r\nNIST 800-53, Rev. 5, IA-5(1) \r\n\n\n21.10 The system shall be capable of putting into place, in their entirety, either the \"basic password standards\" or \"advanced password standards\" described in CJIS Security Policy 5.6.2.1.1.1 and 5.6.2.1.1.2. If PIN and\/or one-time password is also used, the attributes in 5.6.2.1.2 and 5.6.2.1.3 shall also be required.\n\n\nCJIS Security Policy 5.6.2.2\n\n21.11 If the system supports user-based certificates for authentication, the system shall be configurable enough to require them to be 1. user-specific, not device-specific, 2. used only by one user at any given time, and 3. activated for each use by, e.g., a passphrase or PIN.\n\n\nCJIS Security Policy 5.10.1.2.1\u20132\r\n\nCJIS Security Policy Appendix G.6\r\n\nNIST 800-53, Rev. 5, AC-17(2) \r\n\nNIST 800-53, Rev. 5, SC-13, SC-28, and SC-28(1)\r\n\n\n\n21.12 The system shall allow \"encryption in transit\" and \"encryption at rest\" of criminal justice information (CJI) that meets or exceeds the requirements of CJIS Security Policy 5.10.1.2.1 and 5.10.1.2.2.\n\n\nCJIS Security Policy 5.10.1.5\n\n21.13 If the system is cloud-based, the vendor shall ensure that CJI is stored in databases located within the physical boundaries of APB-member countries and within the legal authority of APB-member agencies. Additionally, the vendor shall agree to not use any metadata derived from unencrypted CJI for commercial, advertising, or other purposes, unless specifically permitted for limited within the service agreement.\n\n\nCJIS Security Policy 5.11.1\u20132\n\n21.14 If the system is cloud-based, the vendor should agree to FBI and CSA compliance and security audits of CJI.\n\n\nCJIS Security Policy 5.10.3.2\r\nCJIS Security Policy Appendix G.1\n\n21.15 If the system is capable of being run in a virtual environment, it shall meet the virtualization requirements set forth in CJIS Security Policy 5.10.3.2 and best practices set forth in CJIS Security Policy Appendix G.1.\n\n\nCJIS Security Policy Appendix G.5\r\nNIST 800-53, Rev. 5, AC-6(4)\r\n\nNIST 800-53, Rev. 5, SC-39\r\n\n\n\n21.16 The system should provide separate processing domains in order to not only allow for more granular allocation of user privileges, but also to prevent one process from modifying the executing code of another process.\n\n\nNIST 800-53, Rev. 5, IA-2(1\u20132), IA-2(12), and IA-8(1)\n\n21.17 The system should support the use of personal identity verification\u2014a U.S. Federal government-wide credential system\u2014and other forms of hardware-based (i.e., public key infrastructure or PKI) token authentication, while electronically verifying those credentials and any configured token quality requirements.\n\n\nA2LA C223 5.4\n\n21.18 The system should support the identification and tagging of infrequently performed forensic tests or analyses in order to alert the analyst and other stakeholders that additional competency verification or method validation is required before performing the test or analysis.\n\n\nA2LA C223 5.9\n\n21.19 The system should allow case records to be scheduled for periodic administrative and technical review by individuals not connected with the case. The conducted review should indicate details such as who conducted the review, what the results were, and when the review was completed. If non-conforming results were discovered, records of determination and resolution should be appended to the case record.\n\n\nA2LA C223 5.9\n\n21.20 The system should be able to document examiner testimony and allow such testimony to be scheduled for periodic evaluation. The conducted evaluation should indicate details such as who conducted the evaluation, what the results were, and when the review was completed. If non-conforming results were discovered, related records of determination and resolution should be maintained in the system.\n\n\n\n22. Clinical and public health data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nCDC PHIN Messaging System\n\n22.1 The system should be capable of interfacing with the Center for Disease Control and Prevention's PHIN Messaging System.\n\n\nACMG Technical Standards for Clinical Genetics Laboratories G1.5\r\n\n\n22.2 The system should support Human Genome Variation Society (HGVS) nomenclature and terminology for sequence variants.\n\n\nCLSI QMS22 2.1.2.3\n\n22.3 The system should be able to collect sufficient test utilization information to make necessity checks on ordered tests against established benchmarks.\n\n\nONC USCDI v2\n\n22.4 The system should support the United States Core Data for Interoperability (USCDI) v2 standard, which in turn supports data interoperability across multiple clinical settings.\n\n\n\n23. Veterinary data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nNAHLN Information Technology System\r\nVeNom Coding Group\r\nVeterinary Terminology Services Laboratory\n\n23.1 The system should support standardized veterinary clinical terminology such as that found in the Veterinary Extension of SNOMED CT and the Veterinary Nomenclature (VeNom) Codes.\n\n\nICAR 15 Data Exchange\r\nVICH GL53\n\n23.2 The system should be able to exchange data, when necessary, in a fashion that meets International Committee for Animal Recording (ICAR) and Veterinary International Conference on Harmonization (VICH) electronic data exchange guidelines.\n\n\nNAHLN HL7 Messaging Quick User Guide\n\n23.3 The system should support National Animal Health Laboratory Network (NAHLN), and, by extension, Health Level 7 (HL7) result messaging.\n\n\n\n24. Scientific data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASTM E1578-18 E-11-1\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.1 The system shall capture raw instrument data and metadata either as an electronic file or directly via RS-232 or TCP\/IP communication.\n\n\nASTM E1578-18 E-11-2\n\n24.2 The scientific data management system (SDMS) should provide a checksum verification of source and destination data and store that verification data in a secure server with controlled access.\n\n\n\nASTM E1578-18 E-11-1\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.3 The system shall store metadata related to raw instrument data in a database in such a way that the original data generated by instruments for specific samples and tests is easy to retrieve.\n\n\nASTM E1578-18 E-11-4\n\n24.4 The system should be capable of capturing a complete and readable copy of original data and any previous versions of modified data in order to maintain the integrity of that data.\n\n\n\nAAVLD AAVLD Requirements for an AVMDL Sec. 4.10.2.3\r\n\nASTM E1578-18 E-11-5\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.5 The system should secure raw data such that it can't be deleted and provide version control when data is modified by any user or specific software.\n\n\nASTM E1578-18 E-11-6\n\n24.6 The SDMS should provide tools for helping a laboratory achieve the U.S. Food and Drug Administration's defined ALCOA principles.\n\n\nASTM E1578-18 E-11-7\n\n24.7 The SDMS shall provide security and access controls for protecting stored data.\n\n\nASTM E1578-18 E-11-8\n\n24.8 The SDMS shall record an audit trail for each and every record created and modified, using version control.\n\n\n45 CFR Part 164.308\r\nASTM E1578-18 E-11-9\n\n24.9 The SDMS shall provide proper systems for backing up, restoring, and archiving data for long-term use.\n\n\n\n25. Health information technology \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n45 CFR Part 170.315 (a-1\u2013a-4)\n\n25.1 The electronic health record (EHR) module should provide computerized provider order entry (CPOE) functionality for medication orders, laboratory orders, and diagnostic imaging, including making checks for potential drug-drug and drug-allergy interactions.\n\n\n45 CFR Part 170.315 (a-5)\r\n45 CFR Part 170.315 (a-11\u2013a-12)\r\n45 CFR Part 170.315 (a-15)\n\n25.2 The EHR module should allow authorized personnel to record, change, and access patient demographic data, including, but not limited to, race and ethnicity, patient's preferred language, birth sex, current sex, sexual orientation, gender identity, birth date, smoking status, alcohol use, family health history, psychological aspects, social aspects, and behavioral aspects.\n\n\n45 CFR Part 170.315 (a-6\u2013a-8)\r\n45 CFR Part 170.315 (a-10)\r\n45 CFR Part 170.315 (a-14)\n\n25.3 The EHR module should allow authorized personnel to record, change, and access a patient's active problem list, medication list, medication allergy list, preferred drug list, and implantable device list, incorporating, where appropriate, at a minimum the SNOMED CT nomenclature standard.\n\n\n45 CFR Part 170.315 (a-19)\n\n25.4 The EHR module should incorporate configurable, role-based clinical decision support tools capable of allowing authorized personnel to trigger electronic interventions based on liked reference information standardized to Health Level 7 (HL7) Version 3 implementation guides. The reference information should be sourced.\n\n\n45 CFR Part 170.315 (a-13)\n\n25.5 The EHR module should be able to identify education resources specific to a patient's active problem and medication lists. The educational resources should be standardized to Health Level 7 (HL7) Version 3 implementation guides.\n\n\n45 CFR Part 170.315 (b-1\u2013b-2; b-4\u2013b-5)\n\n25.6 The EHR module should allow authorized personnel to create, view, send, and receive transition of care or referral summaries in such a way that the summary is properly formatted, matched to the correct patient, and reconciled according to the standards and protocols outlined in 45 CFR Part 170.315 (b-1), (b-2), (b-4), and (b-5).\n\n\n45 CFR Part 170.315 (b-3)\n\n25.7 The EHR module should allow authorized personnel to conduct electronic prescribing actions such as creating, changing, cancelling, and refilling prescriptions, incorporating at least the RxNorm and NCPDP SCRIPT standards.\n\n\n45 CFR Part 170.315 (b-6)\n\n25.8 The EHR module should allow authorized personnel to configure, create, and store data exports, incorporating at least HL7 Version 3 implementation standards, as well as SNOMED CT and ICD-9 standards.\n\n\n45 CFR Part 170.315 (b-7\u2013b-8)\n\n25.9 The EHR module should allow for the secure creation, sending, and receipt of restricted summary records, incorporating HL7 Version 3 implementation standards.\n\n\n45 CFR Part 170.315 (b-9)\n\n25.10 The EHR module should allow authorized personnel to create, record, change, access, and receive care plan information, incorporating HL7 Version 3 implementation standards.\n\n\n45 CFR Part 170.315 (c)\n\n25.11 The EHR module should provide a means to record, calculate, import, export, filter, and report on clinical quality measures according to the standards outlined in 45 CFR Part 170.315 (c).\n\n\n45 CFR Part 170.315 (d)\n\n25.12 The EHR module shall provide security and access controls for protecting stored data.\n\n\n45 CFR Part 170.315 (d)\n\n25.13 The EHR module shall record an audit trail for each and every record created and modified, using version control.\n\n\n45 CFR Part 170.315 (d-7)\n\n25.14 The EHR module shall either encrypt electronic health information on end-user devices after use of the technology on the device stops or prevent electronic health information from being stored on end-user devices after use of the technology on the device stops.\n\n\n45 CFR Part 170.315 (d-8)\n\n25.15 The EHR module shall ensure that electronically exchanged health information has not been altered during the transfer process, using at least a hashing algorithm secured to SHA-2 or better.\n\n\n45 CFR Part 170.315 (d-11)\n\n25.16 The EHR module should be capable of recording patient disclosures made for treatment, payment, and health care operations.\n\n\n45 CFR Part 170.315 (e-1)\n\n25.17 The EHR module should provide a means for patients and their authorized representatives to view, download, and transmit their personal health information and activity history log from the EHR via an internet-based technology, using the standards outlined in 45 CFR Part 170.315 (e-1).\n\n\n45 CFR Part 170.315 (e-2\u2013e-3)\n\n25.18 The EHR module should provide a means for authorized users to securely send messages to and receive messages from patients, at the same time allowing for the recording, accessing, and linking of information shared by the patient electronically (as well as directly).\n\n\n45 CFR Part 170.315 (f)\n\n25.19 The EHR module should allow vital patient information as it relates to public health to be transmitted to immunization registries, cancer registries, and public health agencies, as well as be accessed after the fact. This includes, but is not limited to, immunization history, surveillance information, laboratory test results, cancer case information, case reports, antimicrobial reporting, and health care survey information.\n\n\n45 CFR Part 170.315 (g-3\u2013g-5)\n\n25.20 The EHR developer should use user-centered and accessibility-centered design processes for creating and testing the EHR's functionality. A quality management system should be used during these processes.\n\n\n45 CFR Part 170.315 (g-6)\n\n25.21 The EHR module's use of clinical document architecture (CDA) should be demonstrated and verified for conformance to the standards identified in 45 CFR Part 170.315 (g-6).\n\n\n45 CFR Part 170.315 (g-7\u2013g-9)\n\n25.22 The EHR module should include an application programming interface (API) that demonstrates the EHR's ability to uniquely identify a patient and corresponding ID\/token in a received records or data category request in order to accurately and securely meet the request for that patient's data. The API should be well documented.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#23._Veterinary_data_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#23._Veterinary_data_management<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 2 May 2022, at 20:54.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2,200 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","358bde209d8d7ca4c22ace38b7fe75b4_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Specialty_Laboratory_Functions rootpage-LII_LIMSpec_Specialty_Laboratory_Functions skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Specialty Laboratory Functions<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover the specialty requirements that come with working in specific industries such as agriculture, pharmaceutical production, and <a href=\"https:\/\/www.limswiki.org\/index.php\/Forensic_science\" title=\"Forensic science\" class=\"wiki-link\" data-key=\"415d36a7b65494677b6d2873d5febec1\">forensic science<\/a>. You'll likely notice that most of the content here isn't covered by <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a>.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"17._Production_management\">17. Production management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.103\" target=\"_blank\">21 CFR Part 211.103<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40 (d)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.4 and 16.20<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.1<\/b> The system should be able to calculate and record theoretical and actual percentage of yield at various phases of processing, manufacturing, and packaging.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.103\" target=\"_blank\">21 CFR Part 211.103<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.2<\/b> The system should provide a means for verification and approval of yield calculations before release for reporting.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.20\" target=\"_blank\">21 CFR Part 820.20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.186\" target=\"_blank\">21 CFR Part 820.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 1.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.3<\/b> The system shall be able to maintain a production facility's quality system in a specific quality system record, in accordance with regulations and guidance such as 21 CFR Part 820.20 and 820.40 (U.S.), E.U. Commission Directive 2003\/94\/EC Article 11 (E.U.), and WHO Technical Report Series, #986, Annex 2, 1.0 (global).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.30\" target=\"_blank\">21 CFR Part 820.30<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (e)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.4<\/b> The system shall be able to create a design control document capable of recording the details surrounding device development, including control number, physical and performance requirements, final output, review, verification, approval, transfer, changes, and complete design history.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.181\" target=\"_blank\">21 CFR Part 820.181<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.184\" target=\"_blank\">21 CFR Part 820.184<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.5<\/b> The system shall be able to create a device master and device history record capable of recording all information described in 21 CFR Part 820.181 and 820.184.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.255\u2013260<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.130\" target=\"_blank\">21 CFR Part 211.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.134\" target=\"_blank\">21 CFR Part 211.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.20\" target=\"_blank\">21 CFR Part 211.20 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.50\" target=\"_blank\">21 CFR Part 211.50 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.202\" target=\"_blank\">21 CFR Part 225.202<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.60\" target=\"_blank\">21 CFR Part 820.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 2 and 4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f\u2013g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.25\u201330<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.6<\/b> The system shall be able to create a batch production record capable of recording complete information regarding batch production and control details such as, but not limited to, a unique batch, lot, or production run number; formulation; specific labeling and packaging; production steps; in-process and laboratory control results; the unique identifier of any equipment used; persons performing and\/or supervising operational steps; and the results of any pre-process or post-production inspections.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.205\u2013210<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.186\" target=\"_blank\">21 CFR Part 211.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.22\u201323<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.7<\/b> The system shall be able to create a master production and control record capable of recording complete information regarding master production and control details.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.150 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.186\" target=\"_blank\">21 CFR Part 211.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 10.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.8<\/b> The system shall require a new or modified master production and control record to be validated, reviewed, and approved before being implemented into production, including allowing that record to be electronically signed by one or more authorized individuals upon approval. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.150 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.22\" target=\"_blank\">21 CFR Part 211.22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.75\" target=\"_blank\">21 CFR Part 820.75<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b, f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.9<\/b> The system shall require a new or modified production and control record to be validated, reviewed, and approved before being implemented in production. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 14.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.10<\/b> The system shall be able to indicate if a sample consists of an in-process manufacturing material and track characteristics of the in-process material such as identity, strength, quality, purity, and approval status.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.11<\/b> The system shall provide a means to track the amount of time between production processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (f-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c) and (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.60\" target=\"_blank\">21 CFR Part 820.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.5.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 14.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.32\u201333<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.12<\/b> The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, certificates of conformity, shelf life or expiration date, storage location, status of examination, and status of approval for use. Any related specifications for those materials should be able to be linked to the received materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.125\" target=\"_blank\">21 CFR Part 211.125 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.7 and 14.22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.35<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.13<\/b> The system shall be capable of recording the changing quantity of inventoried non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, labeling, containers, and packaging materials), including batch and lot numbers and, if applicable, details of disposition after completion of production.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.113<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.125\" target=\"_blank\">21 CFR Part 211.125 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (d\u2013e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.90\" target=\"_blank\">21 CFR Part 820.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.160\" target=\"_blank\">21 CFR Part 820.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 23<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.4, 14.26, and 14.28<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.44\u201345<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.36<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.18\u201319<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.14<\/b> The system shall prevent the internal release for distribution of a completed production batch until an authorized individual has determined the batch's conformance to final specifications and has approved it for release. If a batch is nonconforming, the system shall be able to clearly document it as such (so as to not distribute it) and provide a review and disposition process. Such approval, rejection, review, and disposition activities shall be documented.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\/subpart-C\" target=\"_blank\">21 CFR Part 7 Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.139<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.38<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\/subpart-B\" target=\"_blank\">21 CFR Part 810 Subpart B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 15.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 6.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.32<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.15<\/b> The system shall provide a means to track and record recall activities of manufactured product and devices based on lot, batch, or other identifier, including storage location, necessary disposition details, and reconciliation between distributed and recovered quantities.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.520<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.165\" target=\"_blank\">21 CFR Part 211.165 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.204\" target=\"_blank\">21 CFR Part 211.204<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.71\" target=\"_blank\">21 CFR Part 212.71 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.90\" target=\"_blank\">21 CFR Part 820.90 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.29\u201330<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.16<\/b> The system should allow a completed production batch that has been rejected for use or a returned production batch to be flagged in the system for reprocessing or reworking if it meets relevant criteria.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.145<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 4.11.8.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, I - FSM 19.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 11.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.17<\/b> The system shall support environmental testing protocols for testing the production environment on a scheduled, reportable basis. That support shall include facility and sampling site management functionality that allows for highlighting specific test points in the facility, as well as support for offsite and randomized testing. The system should also allow associated samples, methods, tests, reports, and other documents to clearly indicate they correspond to specific environmental testing protocols.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"18._Statistical_trending_and_control_charts\">18. Statistical trending and control charts<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.7.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-10-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>18.1<\/b> The system should allow authorized users to configure the generation of statistical trending and control charts.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.7.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-10-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>18.2<\/b> The system should allow authorized users to choose specific sample types, tests, and parameters associated with the statistical trending and control charts that can be generated.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"19._Agriculture_and_food_data_management\">19. Agriculture and food data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/orapartners.fda.gov\/cs\/groups\/public\/documents\/document\/b2hh\/bmri\/~edisp\/rpohandbook.pdf\" target=\"_blank\">FDA Office of Regulatory Affairs Data Exchange (ORA DX) Program<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.1<\/b> The system should be able to create or convert an XML or XLS file to ORA DX template specifications, including the use of ORA DX terminology.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.2<\/b> The system shall allow for the assignment of the \"regulatory sample collection\" role and be able to produce a list of individuals in said role, including information such as name, locations assigned, part- or full-time role, and full-time equivalents (if any) used to meet any regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.3<\/b> The system shall allow for the documentation of sampling sites used for normal and regulatory sampling and be able to produce a complete list of such sites on-demand. The documentation should allow for details such as the addition of a unique, never-before-used site code; a region code; demographics; date added to or removed from the system; facility type; sample substrates or commodities available at the site; and relative volume information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.4.12 and 5.4.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.4<\/b> The system shall allow a site that is no longer active for sampling purposes be designated as inactive, yet be allowed to remain on any generated master list. Additionally, such inactive site shall maintain its unique site number in the event the site becomes reinstated as active.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.130\u2013135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507, Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.2, 3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - HACCP 1.X<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 2.2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 2.2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>19.5<\/b> The system shall allow for the development and documentation of hazard analysis and critical control points (HACCP) or other regulatory-driven food safety plan steps, as well as the implementation of those CCPs or steps into configurable laboratory workflow.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.6<\/b> The system shall require a new or modified HACCP or other regulatory-driven food safety plan be validated, reviewed, and approved before being implemented, including requiring that plan to be electronically signed by one or more authorized individuals upon approval.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.92<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>19.7<\/b> The system shall allow for the documentation and management of internal and external audit activities, while allowing samples, methods, tests, results, reports, documents, and more to be clearly associated with that corresponding audit activity.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"20._Environmental_data_management\">20. Environmental data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/geospatial\/epa-metadata-technical-specification\" target=\"_blank\">EPA Metadata Technical Specification<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.1<\/b> The system should support metadata requirements set forth by ISO 19115 and the EPA Metadata Technical Specification for reporting and data publishing purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.2<\/b> The system should support the manual entry or electronic transfer of EPA analytical service requests (ASRs), along with all the required fields of the ASR, including project identifier, project demographics, sample specifics, sample hazards, reporting requirements, and special requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/2015-07\/documents\/sedd52_specification.pdf\" target=\"_blank\">EPA SEDD Specification and Data Element Dictionary v5.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.3<\/b> The system should support the creation and transfer of Staged Electronic Data Deliverable (SEDD) files.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.10\" target=\"_blank\">40 CFR Part 3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/60\" target=\"_blank\">40 CFR Part 60 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/62\" target=\"_blank\">40 CFR Part 62 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/63\" target=\"_blank\">40 CFR Part 63 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>20.4<\/b> The system shall support generating electronic environmental reports (e.g., stationary source emissions tests) in either the EPA's Electronic Reporting Tool (ERT) special spreadsheet format or in an XML file format that complies with EPA-approved XML schema.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/denix.osd.mil\/edqw\/documents\/documents\/gen-data-validation-rev1\/\" target=\"_blank\">DoD General Data Validation Guidelines<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.5<\/b> The system should support electronic data deliverable (EDD) validation by linking the EDD to its quality assurance project plan (QAPP) and the appropriate stage of validation for the EDD's data type.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"21._Forensic_case_and_data_management\">21. Forensic case and data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.4.3<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1459-13 2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 4.1.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 4.1.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 4.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.1<\/b> The system shall be able to assign each piece of collected evidence and each scene a unique identifier using methodologies such as an ID with an incrementing integer (for sequential evidence numbers) or a user-defined naming format for meeting regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.6\u201310<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.2<\/b> The system shall be able to assign each case a unique case identifier that, in addition to an electronic signature, is able to be automatically placed on, at a maximum, each page of the case's associated examination and administration records.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.5.1.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.3<\/b> In addition to a unique case number, the system shall provide a means to add additional information to a case file, including, but not limited to, submitting agency, agency case number, date of case receipt, name of recipient, shipping and receipt details, items associated with the case and their unique designators, notes, test data, related reports, and other documentation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 (throughout)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 (throughout)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.4.3 and 4.5.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.4<\/b> The system should be able to document evidence using an ASTM-compliant evidence log, including, but not limited to, unique identifiers, investigator and custodian names, key dates and times, evidence conditions, and storage location.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.1.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.5<\/b> The system should be able to prevent a piece of evidence from being scheduled for destructive testing until an appropriate authorization for such analysis is acquired and documented.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.6<\/b> The system shall be able to record and maintain chain of custody of evidence that is subdivided in the laboratory in the same way that original evidence items are tracked.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.1.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.7<\/b> The system shall be capable of recording the secondary dissemination to an authorized agency or organization of criminal history record information (CHRI) sourced from U.S. Criminal Justice Information Services (CJIS).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.8<\/b> The system shall be able to record all National Crime Information Center (NCIC) and Interstate Identification Index (III) data transactions, clearly identifying the operator and authorized receiving agency or organization. III records shall also identify requester and recipient using a unique identifier.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(1) <\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.9<\/b> If the system provides remote access to authorized users over authorized devices, the remote access shall be monitored, controlled and documented, particularly for privileged functions. If remote access to privileged functions is allowed, virtual escorting that meets CJIS Security Policy 5.5.6 conditions will be required.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.1.1.1\u20132<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.1.2\u20133<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5(1) <\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.10<\/b> The system shall be capable of putting into place, in their entirety, either the \"basic password standards\" or \"advanced password standards\" described in CJIS Security Policy 5.6.2.1.1.1 and 5.6.2.1.1.2. If PIN and\/or one-time password is also used, the attributes in 5.6.2.1.2 and 5.6.2.1.3 shall also be required.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.11<\/b> If the system supports user-based certificates for authentication, the system shall be configurable enough to require them to be 1. user-specific, not device-specific, 2. used only by one user at any given time, and 3. activated for each use by, e.g., a passphrase or PIN.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2.1\u20132<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(2) <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-13, SC-28, and SC-28(1)<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.12<\/b> The system shall allow \"encryption in transit\" and \"encryption at rest\" of criminal justice information (CJI) that meets or exceeds the requirements of CJIS Security Policy 5.10.1.2.1 and 5.10.1.2.2.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.13<\/b> If the system is cloud-based, the vendor shall ensure that CJI is stored in databases located within the physical boundaries of APB-member countries and within the legal authority of APB-member agencies. Additionally, the vendor shall agree to not use any metadata derived from unencrypted CJI for commercial, advertising, or other purposes, unless specifically permitted for limited within the service agreement.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.11.1\u20132<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.14<\/b> If the system is cloud-based, the vendor should agree to FBI and CSA compliance and security audits of CJI.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.3.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.15<\/b> If the system is capable of being run in a virtual environment, it shall meet the virtualization requirements set forth in CJIS Security Policy 5.10.3.2 and best practices set forth in CJIS Security Policy Appendix G.1.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6(4)<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-39<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.16<\/b> The system should provide separate processing domains in order to not only allow for more granular allocation of user privileges, but also to prevent one process from modifying the executing code of another process.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2(1\u20132), IA-2(12), and IA-8(1)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.17<\/b> The system should support the use of personal identity verification\u2014a U.S. Federal government-wide credential system\u2014and other forms of hardware-based (i.e., public key infrastructure or PKI) token authentication, while electronically verifying those credentials and any configured token quality requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.18<\/b> The system should support the identification and tagging of infrequently performed forensic tests or analyses in order to alert the analyst and other stakeholders that additional competency verification or method validation is required before performing the test or analysis.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.19<\/b> The system should allow case records to be scheduled for periodic administrative and technical review by individuals not connected with the case. The conducted review should indicate details such as who conducted the review, what the results were, and when the review was completed. If non-conforming results were discovered, records of determination and resolution should be appended to the case record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.20<\/b> The system should be able to document examiner testimony and allow such testimony to be scheduled for periodic evaluation. The conducted evaluation should indicate details such as who conducted the evaluation, what the results were, and when the review was completed. If non-conforming results were discovered, related records of determination and resolution should be maintained in the system.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"22._Clinical_and_public_health_data_management\">22. Clinical and public health data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/phin\/tools\/phinms\/index.html\" target=\"_blank\">CDC PHIN Messaging System<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.1<\/b> The system should be capable of interfacing with the Center for Disease Control and Prevention's PHIN Messaging System.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.5<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>22.2<\/b> The system should support Human Genome Variation Society (HGVS) nomenclature and terminology for sequence variants.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.3<\/b> The system should be able to collect sufficient test utilization information to make necessity checks on ordered tests against established benchmarks.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healthit.gov\/isa\/united-states-core-data-interoperability-uscdi\" target=\"_blank\">ONC USCDI v2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.4<\/b> The system should support the United States Core Data for Interoperability (USCDI) v2 standard, which in turn supports data interoperability across multiple clinical settings.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"23._Veterinary_data_management\">23. Veterinary data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphis.usda.gov\/aphis\/ourfocus\/animalhealth\/lab-info-services\/nahln\/ct_nahln_it\" target=\"_blank\">NAHLN Information Technology System<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/venomcoding.org\/\" target=\"_blank\">VeNom Coding Group<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vtsl.vetmed.vt.edu\/\" target=\"_blank\">Veterinary Terminology Services Laboratory<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.1<\/b> The system should support standardized veterinary clinical terminology such as that found in the Veterinary Extension of SNOMED CT and the Veterinary Nomenclature (VeNom) Codes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.icar.org\/Guidelines\/15-Data-Exchange.pdf\" target=\"_blank\">ICAR 15 Data Exchange<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vichsec.org\/en\/guidelines\/general\" target=\"_blank\">VICH GL53<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.2<\/b> The system should be able to exchange data, when necessary, in a fashion that meets International Committee for Animal Recording (ICAR) and Veterinary International Conference on Harmonization (VICH) electronic data exchange guidelines.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphis.usda.gov\/animal_health\/nahln\/downloads\/MessagingQuickGuide.pdf\" target=\"_blank\">NAHLN HL7 Messaging Quick User Guide<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.3<\/b> The system should support National Animal Health Laboratory Network (NAHLN), and, by extension, Health Level 7 (HL7) result messaging.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"24._Scientific_data_management\">24. Scientific data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.1<\/b> The system shall capture raw instrument data and metadata either as an electronic file or directly via RS-232 or TCP\/IP communication.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.2<\/b> The scientific data management system (SDMS) should provide a checksum verification of source and destination data and store that verification data in a secure server with controlled access.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.3<\/b> The system shall store metadata related to raw instrument data in a database in such a way that the original data generated by instruments for specific samples and tests is easy to retrieve.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.4<\/b> The system should be capable of capturing a complete and readable copy of original data and any previous versions of modified data in order to maintain the integrity of that data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD AAVLD Requirements for an AVMDL Sec. 4.10.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.5<\/b> The system should secure raw data such that it can't be deleted and provide version control when data is modified by any user or specific software.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.6<\/b> The SDMS should provide tools for helping a laboratory achieve the U.S. Food and Drug Administration's defined ALCOA principles.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.7<\/b> The SDMS shall provide security and access controls for protecting stored data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.8<\/b> The SDMS shall record an audit trail for each and every record created and modified, using version control.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.9<\/b> The SDMS shall provide proper systems for backing up, restoring, and archiving data for long-term use.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"25._Health_information_technology\">25. Health information technology<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-1\u2013a-4)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.1<\/b> The electronic health record (EHR) module should provide computerized provider order entry (CPOE) functionality for medication orders, laboratory orders, and diagnostic imaging, including making checks for potential drug-drug and drug-allergy interactions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-5)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-11\u2013a-12)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-15)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.2<\/b> The EHR module should allow authorized personnel to record, change, and access patient demographic data, including, but not limited to, race and ethnicity, patient's preferred language, birth sex, current sex, sexual orientation, gender identity, birth date, smoking status, alcohol use, family health history, psychological aspects, social aspects, and behavioral aspects.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-6\u2013a-8)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-10)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-14)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.3<\/b> The EHR module should allow authorized personnel to record, change, and access a patient's active problem list, medication list, medication allergy list, preferred drug list, and implantable device list, incorporating, where appropriate, at a minimum the SNOMED CT nomenclature standard.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-19)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.4<\/b> The EHR module should incorporate configurable, role-based clinical decision support tools capable of allowing authorized personnel to trigger electronic interventions based on liked reference information standardized to Health Level 7 (HL7) Version 3 implementation guides. The reference information should be sourced.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-13)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.5<\/b> The EHR module should be able to identify education resources specific to a patient's active problem and medication lists. The educational resources should be standardized to Health Level 7 (HL7) Version 3 implementation guides.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-1\u2013b-2; b-4\u2013b-5)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.6<\/b> The EHR module should allow authorized personnel to create, view, send, and receive transition of care or referral summaries in such a way that the summary is properly formatted, matched to the correct patient, and reconciled according to the standards and protocols outlined in 45 CFR Part 170.315 (b-1), (b-2), (b-4), and (b-5).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.7<\/b> The EHR module should allow authorized personnel to conduct electronic prescribing actions such as creating, changing, cancelling, and refilling prescriptions, incorporating at least the RxNorm and NCPDP SCRIPT standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-6)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.8<\/b> The EHR module should allow authorized personnel to configure, create, and store data exports, incorporating at least HL7 Version 3 implementation standards, as well as SNOMED CT and ICD-9 standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-7\u2013b-8)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.9<\/b> The EHR module should allow for the secure creation, sending, and receipt of restricted summary records, incorporating HL7 Version 3 implementation standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-9)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.10<\/b> The EHR module should allow authorized personnel to create, record, change, access, and receive care plan information, incorporating HL7 Version 3 implementation standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (c)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.11<\/b> The EHR module should provide a means to record, calculate, import, export, filter, and report on clinical quality measures according to the standards outlined in 45 CFR Part 170.315 (c).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.12<\/b> The EHR module shall provide security and access controls for protecting stored data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.13<\/b> The EHR module shall record an audit trail for each and every record created and modified, using version control.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.14<\/b> The EHR module shall either encrypt electronic health information on end-user devices after use of the technology on the device stops or prevent electronic health information from being stored on end-user devices after use of the technology on the device stops.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-8)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.15<\/b> The EHR module shall ensure that electronically exchanged health information has not been altered during the transfer process, using at least a hashing algorithm secured to SHA-2 or better.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-11)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.16<\/b> The EHR module should be capable of recording patient disclosures made for treatment, payment, and health care operations.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (e-1)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.17<\/b> The EHR module should provide a means for patients and their authorized representatives to view, download, and transmit their personal health information and activity history log from the EHR via an internet-based technology, using the standards outlined in 45 CFR Part 170.315 (e-1).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (e-2\u2013e-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.18<\/b> The EHR module should provide a means for authorized users to securely send messages to and receive messages from patients, at the same time allowing for the recording, accessing, and linking of information shared by the patient electronically (as well as directly).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (f)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.19<\/b> The EHR module should allow vital patient information as it relates to public health to be transmitted to immunization registries, cancer registries, and public health agencies, as well as be accessed after the fact. This includes, but is not limited to, immunization history, surveillance information, laboratory test results, cancer case information, case reports, antimicrobial reporting, and health care survey information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-3\u2013g-5)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.20<\/b> The EHR developer should use user-centered and accessibility-centered design processes for creating and testing the EHR's functionality. A quality management system should be used during these processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-6)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.21<\/b> The EHR module's use of clinical document architecture (CDA) should be demonstrated and verified for conformance to the standards identified in 45 CFR Part 170.315 (g-6).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-7\u2013g-9)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.22<\/b> The EHR module should include an application programming interface (API) that demonstrates the EHR's ability to uniquely identify a patient and corresponding ID\/token in a received records or data category request in order to accurately and securely meet the request for that patient's data. The API should be well documented.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173544\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.091 seconds\nReal time usage: 0.100 seconds\nPreprocessor visited node count: 377\/1000000\nPost\u2010expand include size: 77243\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 20.131 1 -total\n 12.96% 2.609 1 Template:LIMSpec\/Production_management\n 11.73% 2.361 1 Template:LIMSpec\/Environmental_data_management\n 11.17% 2.248 1 Template:LIMSpec\/Veterinary_data_management\n 11.10% 2.234 1 Template:LIMSpec\/Health_information_technology\n 10.88% 2.191 1 Template:LIMSpec\/Scientific_data_management\n 9.85% 1.984 1 Template:LIMSpec\/Public_health_data_management\n 9.80% 1.973 1 Template:LIMSpec\/Forensic_case_and_data_management\n 9.37% 1.887 1 Template:LIMSpec\/Agriculture_and_food_data_management\n 9.11% 1.833 1 Template:LIMSpec\/Statistical_trending_and_control_charts\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11203-0!canonical and timestamp 20221202173544 and revision id 47561. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#23._Veterinary_data_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#23._Veterinary_data_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","358bde209d8d7ca4c22ace38b7fe75b4_images":[],"358bde209d8d7ca4c22ace38b7fe75b4_timestamp":1670002545,"16390a68203fc9b7cc3f655664554328_type":"article","16390a68203fc9b7cc3f655664554328_title":"22. Clinical and public health data management","16390a68203fc9b7cc3f655664554328_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#22._Clinical_and_public_health_data_management","16390a68203fc9b7cc3f655664554328_plaintext":"\n\nLII:LIMSpec\/Specialty Laboratory FunctionsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover the specialty requirements that come with working in specific industries such as agriculture, pharmaceutical production, and forensic science. You'll likely notice that most of the content here isn't covered by ASTM E1578-18.\n\n17. Production management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 211.103\r\n21 CFR Part 226.40 (d)\r\nWHO Technical Report Series, #986, Annex 2, 16.4 and 16.20\n\n17.1 The system should be able to calculate and record theoretical and actual percentage of yield at various phases of processing, manufacturing, and packaging.\n\n\n21 CFR Part 211.103\n\n17.2 The system should provide a means for verification and approval of yield calculations before release for reporting.\n\n\n\n21 CFR Part 820.20\r\n\n21 CFR Part 820.40\r\n\n21 CFR Part 820.186\r\n\nE.U. Commission Directive 2003\/94\/EC Article 11\r\n\nWHO Technical Report Series, #986, Annex 2, 1.0\n\n\n17.3 The system shall be able to maintain a production facility's quality system in a specific quality system record, in accordance with regulations and guidance such as 21 CFR Part 820.20 and 820.40 (U.S.), E.U. Commission Directive 2003\/94\/EC Article 11 (E.U.), and WHO Technical Report Series, #986, Annex 2, 1.0 (global).\n\n\n21 CFR Part 820.30\r\n21 CFR Part 820.120 (e)\n\n17.4 The system shall be able to create a design control document capable of recording the details surrounding device development, including control number, physical and performance requirements, final output, review, verification, approval, transfer, changes, and complete design history.\n\n\n21 CFR Part 820.181\r\n21 CFR Part 820.184\n\n17.5 The system shall be able to create a device master and device history record capable of recording all information described in 21 CFR Part 820.181 and 820.184.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 111.255\u2013260\r\n\n21 CFR Part 114.100 (b)\r\n\n21 CFR Part 211.105 (b)\r\n\n21 CFR Part 211.130 (e)\r\n\n21 CFR Part 211.134 (c)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.20 (d)\r\n\n21 CFR Part 211.50 (c)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 225.202\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 820.60\r\n\n21 CFR Part 820.70 (a)\r\n\n21 CFR Part 820.80 (c)\r\n\n21 CFR Part 820.120 (d)\r\n\nBRC GSFS, Issue 8, 6.1.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.1.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 8.1\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.1\r\n\nFDA Hazard Analysis Critical Control Point Principle 2 and 4\r\n\nFDA Hazard Analysis Critical Control Point Principle 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11\r\n\nIFS Food 7, Part 2, 4.2.1.1\r\n\nIFS Food 7, Part 2, 4.18.1\r\n\nIFS PACsecure 2, Part 2, 4.2.1.1\r\n\nIFS PACsecure 2, Part 2, 4.18.1\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (3)\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f\u2013g)\r\n\nWHO Technical Report Series, #986, Annex 2, 15.25\u201330\n\n\n17.6 The system shall be able to create a batch production record capable of recording complete information regarding batch production and control details such as, but not limited to, a unique batch, lot, or production run number; formulation; specific labeling and packaging; production steps; in-process and laboratory control results; the unique identifier of any equipment used; persons performing and\/or supervising operational steps; and the results of any pre-process or post-production inspections.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.100 (e)\r\n\n21 CFR Part 111.205\u2013210\r\n\n21 CFR Part 114.100 (b)\r\n\n21 CFR Part 211.186\r\n\n21 CFR Part 212.50 (b)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nBRC GSFS, Issue 8, 3.6.2\r\n\nBRC GSFS, Issue 8, 9.2.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.1.2\r\n\nFDA Hazard Analysis Critical Control Point Principle 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11\r\n\nIFS Food 7, Part 2, 4.2.1.1\r\n\nIFS PACsecure 2, Part 2, 4.2.1.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 15.22\u201323\n\n\n17.7 The system shall be able to create a master production and control record capable of recording complete information regarding master production and control details.\n\n\n\n21 CFR Part 106.100 (e)\r\n\n21 CFR Part 111.123 (a)\r\n\n21 CFR Part 114.100 (c)\r\n\n21 CFR Part 117.150 (d)\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.186\r\n\n21 CFR Part 212.50 (b)\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nBRC GSFS, Issue 8, 9.2.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 10.3\u20134\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.2\r\n\nIFS Food 7, Part 2, 4.2.1.2\r\n\nIFS Food 7, Part 2, 4.3.x\r\n\nIFS Food 7, Part 2, 5.11\r\n\nIFS PACsecure 2, Part 2, 4.2.1.2\r\n\nIFS PACsecure 2, Part 2, 4.3.x\r\n\nIFS PACsecure 2, Part 2, 5.11\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b)\r\n\nWHO Technical Report Series, #986, Annex 2, 4.0\n\n\n17.8 The system shall require a new or modified master production and control record to be validated, reviewed, and approved before being implemented into production, including allowing that record to be electronically signed by one or more authorized individuals upon approval. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n\n\n\n21 CFR Part 111.123 (a)\r\n\n21 CFR Part 114.100 (c)\r\n\n21 CFR Part 117.150 (d)\r\n\n21 CFR Part 211.22\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 820.70 (b)\r\n\n21 CFR Part 820.75\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 10.3\r\n\nIFS Food 7, Part 2, 4.2.1.2\r\n\nIFS Food 7, Part 2, 4.3.x\r\n\nIFS Food 7, Part 2, 5.11\r\n\nIFS PACsecure 2, Part 2, 4.2.1.2\r\n\nIFS PACsecure 2, Part 2, 4.3.x\r\n\nIFS PACsecure 2, Part 2, 5.11\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b, f)\r\n\nWHO Technical Report Series, #986, Annex 2, 4.0\n\n\n17.9 The system shall require a new or modified production and control record to be validated, reviewed, and approved before being implemented in production. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n\n\n\n21 CFR Part 211.110\r\n\n21 CFR Part 212.50\r\n\n21 CFR Part 820.80 (c)\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\r\n\nISO\/TS 22002-1:2009, 14.3\n\n\n17.10 The system shall be able to indicate if a sample consists of an in-process manufacturing material and track characteristics of the in-process material such as identity, strength, quality, purity, and approval status.\n\n\n21 CFR Part 211.111\n\n17.11 The system shall provide a means to track the amount of time between production processes.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.80\r\n\n21 CFR Part 106.100 (f-6)\r\n\n21 CFR Part 117.420\r\n\n21 CFR Part 211.122 (c)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 212.20 (b)\r\n\n21 CFR Part 212.40 (c) and (e)\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.40 (b)\r\n\n21 CFR Part 226.42\r\n\n21 CFR Part 606.120 (b)\r\n\n21 CFR Part 820.60\r\n\n21 CFR Part 820.80 (b)\r\n\n21 CFR Part 820.120 (b)\r\n\nBRC GSFS, Issue 8, 3.6.1\r\n\nBRC GSFS, Issue 8, 3.9.2\r\n\nBRC GSFS, Issue 8, 5.4.4\r\n\nBRC GSFS, Issue 8, 3.5.1\r\n\nBRC GSFS, Issue 8, 9.5.1\u20132\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17\r\n\nIFS Food 7, Part 2, 4.5.2\r\n\nIFS Food 7, Part 2, 4.18.1\r\n\nIFS PACsecure 2, Part 2, 4.5.2\r\n\nIFS PACsecure 2, Part 2, 4.18.1\r\n\nISO\/TS 22002-1:2009, 9.3\r\n\nISO\/TS 22002-1:2009, 14.2\r\n\nISO\/TS 22002-4:2013, 4.6.3\r\n\nISO\/TS 22002-4:2013, 4.11.2\r\n\nISO\/TS 22002-6:2016, 4.6.3\r\n\nISO\/TS 22002-6:2016, 4.11.2\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nWHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21\r\n\nWHO Technical Report Series, #986, Annex 2, 15.32\u201333\n\n\n17.12 The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, certificates of conformity, shelf life or expiration date, storage location, status of examination, and status of approval for use. Any related specifications for those materials should be able to be linked to the received materials.\n\n\n\n21 CFR Part 211.122 (e)\r\n\n21 CFR Part 211.125 (d)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.42\r\n\nBRC GSFS, Issue 8, 3.5.3\r\n\nBRC GSFS, Issue 8, 9.5.3\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17\r\n\nWHO Technical Report Series, #986, Annex 2, 14.7 and 14.22\r\n\nWHO Technical Report Series, #986, Annex 2, 16.35\n\n\n17.13 The system shall be capable of recording the changing quantity of inventoried non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, labeling, containers, and packaging materials), including batch and lot numbers and, if applicable, details of disposition after completion of production.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.70\r\n\n21 CFR Part 111.113\r\n\n21 CFR Part 111.123 (b)\r\n\n21 CFR Part 114.100 (d)\r\n\n21 CFR Part 120.10\r\n\n21 CFR Part 123.6\r\n\n21 CFR Part 211.122 (e)\r\n\n21 CFR Part 211.125 (d)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.42\r\n\n21 CFR Part 606.100 (c)\r\n\n21 CFR Part 820.80 (d\u2013e)\r\n\n21 CFR Part 820.90\r\n\n21 CFR Part 820.160\r\n\nBRC GSFS, Issue 8, 3.8.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.2\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 23\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\nIFS Food 7, Part 2, 5.7.1\r\n\nIFS Food 7, Part 2, 5.10\r\n\nIFS PACsecure 2, Part 2, 5.7.1\r\n\nIFS PACsecure 2, Part 2, 5.10\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.5\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.7\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.5\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.7\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.5\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.7\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (g)\r\n\nWHO Technical Report Series, #986, Annex 2, 14.4, 14.26, and 14.28\r\n\nWHO Technical Report Series, #986, Annex 2, 15.44\u201345\r\n\nWHO Technical Report Series, #986, Annex 2, 16.36\r\n\nWHO Technical Report Series, #986, Annex 2, 17.18\u201319\n\n\n17.14 The system shall prevent the internal release for distribution of a completed production batch until an authorized individual has determined the batch's conformance to final specifications and has approved it for release. If a batch is nonconforming, the system shall be able to clearly document it as such (so as to not distribute it) and provide a review and disposition process. Such approval, rejection, review, and disposition activities shall be documented.\n\n\n\n21 CFR Part 7 Subpart C\r\n\n21 CFR Part 117.139\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 507.38\r\n\n21 CFR Part 810 Subpart B\r\n\nBRC GSFS, Issue 8, 3.11.2\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.5\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\nIFS Food 7, Part 2, 5.9.2\r\n\nIFS PACsecure 2, Part 2, 5.9.2\r\n\nISO\/TS 22002-1:2009, 15.x\r\n\nISO\/TS 22002-4:2013, 4.12\r\n\nISO\/TS 22002-6:2016, 4.12\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.6.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.6.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.3\r\n\nWHO Technical Report Series, #986, Annex 2, 6.0\r\n\nWHO Technical Report Series, #986, Annex 2, 14.32\n\n\n17.15 The system shall provide a means to track and record recall activities of manufactured product and devices based on lot, batch, or other identifier, including storage location, necessary disposition details, and reconciliation between distributed and recovered quantities.\n\n\n\n21 CFR Part 111.520\r\n\n21 CFR Part 211.165 (f)\r\n\n21 CFR Part 211.204\r\n\n21 CFR Part 212.71 (d)\r\n\n21 CFR Part 820.90 (b-2)\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.6\r\n\nWHO Technical Report Series, #986, Annex 2, 14.29\u201330\n\n\n17.16 The system should allow a completed production batch that has been rejected for use or a returned production batch to be flagged in the system for reprocessing or reworking if it meets relevant criteria.\n\n\n\n21 CFR Part 112.145\r\n\nBRC GSFS, Issue 8, 4.11.8.x\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, I - FSM 19.2\r\n\nISO\/TS 22002-1:2009, 11.5\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.8\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.8\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.8\n\n\n17.17 The system shall support environmental testing protocols for testing the production environment on a scheduled, reportable basis. That support shall include facility and sampling site management functionality that allows for highlighting specific test points in the facility, as well as support for offsite and randomized testing. The system should also allow associated samples, methods, tests, reports, and other documents to clearly indicate they correspond to specific environmental testing protocols.\n\n\n\n18. Statistical trending and control charts \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 820.250\r\n\nAIHA-LAP Policies 2018 2A.7.7.1.3\r\n\nASTM E1578-18 E-10-1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7.2.8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.8\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 9\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\n\n\n18.1 The system should allow authorized users to configure the generation of statistical trending and control charts.\n\n\n\n21 CFR Part 820.250\r\n\nAIHA-LAP Policies 2018 2A.7.7.1.3\r\n\nASTM E1578-18 E-10-2\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7.2.8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.8\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 9\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\n\n\n18.2 The system should allow authorized users to choose specific sample types, tests, and parameters associated with the statistical trending and control charts that can be generated.\n\n\n\n19. Agriculture and food data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nFDA Office of Regulatory Affairs Data Exchange (ORA DX) Program\n\n19.1 The system should be able to create or convert an XML or XLS file to ORA DX template specifications, including the use of ORA DX terminology.\n\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\nUSDA Sampling Procedures for PDP 5.3\r\nUSDA Sampling Procedures for PDP 6.2\n\n19.2 The system shall allow for the assignment of the \"regulatory sample collection\" role and be able to produce a list of individuals in said role, including information such as name, locations assigned, part- or full-time role, and full-time equivalents (if any) used to meet any regulatory requirements.\n\n\nUSDA Sampling Procedures for PDP 5.4\n\n19.3 The system shall allow for the documentation of sampling sites used for normal and regulatory sampling and be able to produce a complete list of such sites on-demand. The documentation should allow for details such as the addition of a unique, never-before-used site code; a region code; demographics; date added to or removed from the system; facility type; sample substrates or commodities available at the site; and relative volume information.\n\n\nUSDA Sampling Procedures for PDP 5.4.12 and 5.4.14\n\n19.4 The system shall allow a site that is no longer active for sampling purposes be designated as inactive, yet be allowed to remain on any generated master list. Additionally, such inactive site shall maintain its unique site number in the event the site becomes reinstated as active.\n\n\n\n21 CFR Part 117.130\u2013135\r\n\n21 CFR Part 120 (throughout)\r\n\n21 CFR Part 123.6\r\n\n21 CFR Part 507, Subpart C\r\n\n61 FR 38806, 9 CFR Part 417.x\r\n\nBRC GSFS, Issue 8, 2.x\r\n\nCodex Alimentarius CXC 1-1969, Ch.2, 3.x\r\n\nE.U. Commission Reg. No. 852\/2004 Article 5\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - HACCP 1.X\r\n\nIFS Food 7, Part 2, 2.2.x\r\n\nIFS PACsecure 2, Part 2, 2.2.x\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.3\n\n\n19.5 The system shall allow for the development and documentation of hazard analysis and critical control points (HACCP) or other regulatory-driven food safety plan steps, as well as the implementation of those CCPs or steps into configurable laboratory workflow.\n\n\n61 FR 38806, 9 CFR Part 417.4\n\n19.6 The system shall require a new or modified HACCP or other regulatory-driven food safety plan be validated, reviewed, and approved before being implemented, including requiring that plan to be electronically signed by one or more authorized individuals upon approval.\n\n\n\n21 CFR Part 106.90\r\n\n21 CFR Part 106.92\r\n\n21 CFR Part 106.94\r\n\n21 CFR Part 106.100 (j)\r\n\nBRC GSFS, Issue 8, 3.4.x\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 20\r\n\nIFS Food 7, Part 2, 5.1\r\n\nIFS PACsecure 2, Part 2, 5.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.4\n\n\n19.7 The system shall allow for the documentation and management of internal and external audit activities, while allowing samples, methods, tests, results, reports, documents, and more to be clearly associated with that corresponding audit activity.\n\n\n\n20. Environmental data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nEPA Metadata Technical Specification\n\n20.1 The system should support metadata requirements set forth by ISO 19115 and the EPA Metadata Technical Specification for reporting and data publishing purposes.\n\n\nEPA ERLN Laboratory Requirements 3.3\n\n20.2 The system should support the manual entry or electronic transfer of EPA analytical service requests (ASRs), along with all the required fields of the ASR, including project identifier, project demographics, sample specifics, sample hazards, reporting requirements, and special requirements.\n\n\nEPA SEDD Specification and Data Element Dictionary v5.2\n\n20.3 The system should support the creation and transfer of Staged Electronic Data Deliverable (SEDD) files.\n\n\n\n40 CFR Part 3.10\r\n\n40 CFR Part 60 (throughout)\r\n\n40 CFR Part 62 (throughout)\r\n\n40 CFR Part 63 (throughout)\n\n\n20.4 The system shall support generating electronic environmental reports (e.g., stationary source emissions tests) in either the EPA's Electronic Reporting Tool (ERT) special spreadsheet format or in an XML file format that complies with EPA-approved XML schema.\n\n\nDoD General Data Validation Guidelines\n\n20.5 The system should support electronic data deliverable (EDD) validation by linking the EDD to its quality assurance project plan (QAPP) and the appropriate stage of validation for the EDD's data type.\n\n\n\n21. Forensic case and data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.4.3\nASTM E1188-11 3.2.3\r\n\nASTM E1188-11 3.4.1\r\n\nASTM E1459-13 2.1\r\n\nASTM E1459-13 4.1.1\u20132\r\n\nASTM E1459-13 4.1.4.2\r\n\nASTM E1459-13 4.2.2\u20133\r\n\nASTM E1492-11 4.1.1\r\n\nASTM E1492-11 4.1.5\n\n\n21.1 The system shall be able to assign each piece of collected evidence and each scene a unique identifier using methodologies such as an ID with an incrementing integer (for sequential evidence numbers) or a user-defined naming format for meeting regulatory requirements.\n\n\nA2LA C223 4.13\r\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.6\u201310\r\nASTM E1492-11 4.1.1\r\n\n\n21.2 The system shall be able to assign each case a unique case identifier that, in addition to an electronic signature, is able to be automatically placed on, at a maximum, each page of the case's associated examination and administration records.\n\n\n\nA2LA C223 4.13\r\n\nASTM E1492-11 4.1.1.1\u20132\r\n\nASTM E1492-11 4.1.4\u20135\r\n\nASTM E1492-11 4.2.2\u20133\r\n\nASTM E1492-11 4.5.1.1\n\n\n21.3 In addition to a unique case number, the system shall provide a means to add additional information to a case file, including, but not limited to, submitting agency, agency case number, date of case receipt, name of recipient, shipping and receipt details, items associated with the case and their unique designators, notes, test data, related reports, and other documentation.\n\n\nASTM E1188-11 (throughout)\r\nASTM E1459-13 (throughout)\r\nASTM E1492-11 4.4.3 and 4.5.1\n\n21.4 The system should be able to document evidence using an ASTM-compliant evidence log, including, but not limited to, unique identifiers, investigator and custodian names, key dates and times, evidence conditions, and storage location.\n\n\nASTM E1492-11 4.3.1.1\n\n21.5 The system should be able to prevent a piece of evidence from being scheduled for destructive testing until an appropriate authorization for such analysis is acquired and documented.\n\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1.1\r\nASTM E1492-11 4.1.2\n\n21.6 The system shall be able to record and maintain chain of custody of evidence that is subdivided in the laboratory in the same way that original evidence items are tracked.\n\n\nCJIS Security Policy 5.1.3\n\n21.7 The system shall be capable of recording the secondary dissemination to an authorized agency or organization of criminal history record information (CHRI) sourced from U.S. Criminal Justice Information Services (CJIS).\n\n\nCJIS Security Policy 5.4.7\n\n21.8 The system shall be able to record all National Crime Information Center (NCIC) and Interstate Identification Index (III) data transactions, clearly identifying the operator and authorized receiving agency or organization. III records shall also identify requester and recipient using a unique identifier.\n\n\nCJIS Security Policy 5.5.6\r\nNIST 800-53, Rev. 5, AC-17(1) \r\n\n\n21.9 If the system provides remote access to authorized users over authorized devices, the remote access shall be monitored, controlled and documented, particularly for privileged functions. If remote access to privileged functions is allowed, virtual escorting that meets CJIS Security Policy 5.5.6 conditions will be required.\n\n\nCJIS Security Policy 5.6.2.1.1.1\u20132\r\nCJIS Security Policy 5.6.2.1.2\u20133\r\nNIST 800-53, Rev. 5, IA-5(1) \r\n\n\n21.10 The system shall be capable of putting into place, in their entirety, either the \"basic password standards\" or \"advanced password standards\" described in CJIS Security Policy 5.6.2.1.1.1 and 5.6.2.1.1.2. If PIN and\/or one-time password is also used, the attributes in 5.6.2.1.2 and 5.6.2.1.3 shall also be required.\n\n\nCJIS Security Policy 5.6.2.2\n\n21.11 If the system supports user-based certificates for authentication, the system shall be configurable enough to require them to be 1. user-specific, not device-specific, 2. used only by one user at any given time, and 3. activated for each use by, e.g., a passphrase or PIN.\n\n\nCJIS Security Policy 5.10.1.2.1\u20132\r\n\nCJIS Security Policy Appendix G.6\r\n\nNIST 800-53, Rev. 5, AC-17(2) \r\n\nNIST 800-53, Rev. 5, SC-13, SC-28, and SC-28(1)\r\n\n\n\n21.12 The system shall allow \"encryption in transit\" and \"encryption at rest\" of criminal justice information (CJI) that meets or exceeds the requirements of CJIS Security Policy 5.10.1.2.1 and 5.10.1.2.2.\n\n\nCJIS Security Policy 5.10.1.5\n\n21.13 If the system is cloud-based, the vendor shall ensure that CJI is stored in databases located within the physical boundaries of APB-member countries and within the legal authority of APB-member agencies. Additionally, the vendor shall agree to not use any metadata derived from unencrypted CJI for commercial, advertising, or other purposes, unless specifically permitted for limited within the service agreement.\n\n\nCJIS Security Policy 5.11.1\u20132\n\n21.14 If the system is cloud-based, the vendor should agree to FBI and CSA compliance and security audits of CJI.\n\n\nCJIS Security Policy 5.10.3.2\r\nCJIS Security Policy Appendix G.1\n\n21.15 If the system is capable of being run in a virtual environment, it shall meet the virtualization requirements set forth in CJIS Security Policy 5.10.3.2 and best practices set forth in CJIS Security Policy Appendix G.1.\n\n\nCJIS Security Policy Appendix G.5\r\nNIST 800-53, Rev. 5, AC-6(4)\r\n\nNIST 800-53, Rev. 5, SC-39\r\n\n\n\n21.16 The system should provide separate processing domains in order to not only allow for more granular allocation of user privileges, but also to prevent one process from modifying the executing code of another process.\n\n\nNIST 800-53, Rev. 5, IA-2(1\u20132), IA-2(12), and IA-8(1)\n\n21.17 The system should support the use of personal identity verification\u2014a U.S. Federal government-wide credential system\u2014and other forms of hardware-based (i.e., public key infrastructure or PKI) token authentication, while electronically verifying those credentials and any configured token quality requirements.\n\n\nA2LA C223 5.4\n\n21.18 The system should support the identification and tagging of infrequently performed forensic tests or analyses in order to alert the analyst and other stakeholders that additional competency verification or method validation is required before performing the test or analysis.\n\n\nA2LA C223 5.9\n\n21.19 The system should allow case records to be scheduled for periodic administrative and technical review by individuals not connected with the case. The conducted review should indicate details such as who conducted the review, what the results were, and when the review was completed. If non-conforming results were discovered, records of determination and resolution should be appended to the case record.\n\n\nA2LA C223 5.9\n\n21.20 The system should be able to document examiner testimony and allow such testimony to be scheduled for periodic evaluation. The conducted evaluation should indicate details such as who conducted the evaluation, what the results were, and when the review was completed. If non-conforming results were discovered, related records of determination and resolution should be maintained in the system.\n\n\n\n22. Clinical and public health data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nCDC PHIN Messaging System\n\n22.1 The system should be capable of interfacing with the Center for Disease Control and Prevention's PHIN Messaging System.\n\n\nACMG Technical Standards for Clinical Genetics Laboratories G1.5\r\n\n\n22.2 The system should support Human Genome Variation Society (HGVS) nomenclature and terminology for sequence variants.\n\n\nCLSI QMS22 2.1.2.3\n\n22.3 The system should be able to collect sufficient test utilization information to make necessity checks on ordered tests against established benchmarks.\n\n\nONC USCDI v2\n\n22.4 The system should support the United States Core Data for Interoperability (USCDI) v2 standard, which in turn supports data interoperability across multiple clinical settings.\n\n\n\n23. Veterinary data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nNAHLN Information Technology System\r\nVeNom Coding Group\r\nVeterinary Terminology Services Laboratory\n\n23.1 The system should support standardized veterinary clinical terminology such as that found in the Veterinary Extension of SNOMED CT and the Veterinary Nomenclature (VeNom) Codes.\n\n\nICAR 15 Data Exchange\r\nVICH GL53\n\n23.2 The system should be able to exchange data, when necessary, in a fashion that meets International Committee for Animal Recording (ICAR) and Veterinary International Conference on Harmonization (VICH) electronic data exchange guidelines.\n\n\nNAHLN HL7 Messaging Quick User Guide\n\n23.3 The system should support National Animal Health Laboratory Network (NAHLN), and, by extension, Health Level 7 (HL7) result messaging.\n\n\n\n24. Scientific data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASTM E1578-18 E-11-1\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.1 The system shall capture raw instrument data and metadata either as an electronic file or directly via RS-232 or TCP\/IP communication.\n\n\nASTM E1578-18 E-11-2\n\n24.2 The scientific data management system (SDMS) should provide a checksum verification of source and destination data and store that verification data in a secure server with controlled access.\n\n\n\nASTM E1578-18 E-11-1\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.3 The system shall store metadata related to raw instrument data in a database in such a way that the original data generated by instruments for specific samples and tests is easy to retrieve.\n\n\nASTM E1578-18 E-11-4\n\n24.4 The system should be capable of capturing a complete and readable copy of original data and any previous versions of modified data in order to maintain the integrity of that data.\n\n\n\nAAVLD AAVLD Requirements for an AVMDL Sec. 4.10.2.3\r\n\nASTM E1578-18 E-11-5\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.5 The system should secure raw data such that it can't be deleted and provide version control when data is modified by any user or specific software.\n\n\nASTM E1578-18 E-11-6\n\n24.6 The SDMS should provide tools for helping a laboratory achieve the U.S. Food and Drug Administration's defined ALCOA principles.\n\n\nASTM E1578-18 E-11-7\n\n24.7 The SDMS shall provide security and access controls for protecting stored data.\n\n\nASTM E1578-18 E-11-8\n\n24.8 The SDMS shall record an audit trail for each and every record created and modified, using version control.\n\n\n45 CFR Part 164.308\r\nASTM E1578-18 E-11-9\n\n24.9 The SDMS shall provide proper systems for backing up, restoring, and archiving data for long-term use.\n\n\n\n25. Health information technology \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n45 CFR Part 170.315 (a-1\u2013a-4)\n\n25.1 The electronic health record (EHR) module should provide computerized provider order entry (CPOE) functionality for medication orders, laboratory orders, and diagnostic imaging, including making checks for potential drug-drug and drug-allergy interactions.\n\n\n45 CFR Part 170.315 (a-5)\r\n45 CFR Part 170.315 (a-11\u2013a-12)\r\n45 CFR Part 170.315 (a-15)\n\n25.2 The EHR module should allow authorized personnel to record, change, and access patient demographic data, including, but not limited to, race and ethnicity, patient's preferred language, birth sex, current sex, sexual orientation, gender identity, birth date, smoking status, alcohol use, family health history, psychological aspects, social aspects, and behavioral aspects.\n\n\n45 CFR Part 170.315 (a-6\u2013a-8)\r\n45 CFR Part 170.315 (a-10)\r\n45 CFR Part 170.315 (a-14)\n\n25.3 The EHR module should allow authorized personnel to record, change, and access a patient's active problem list, medication list, medication allergy list, preferred drug list, and implantable device list, incorporating, where appropriate, at a minimum the SNOMED CT nomenclature standard.\n\n\n45 CFR Part 170.315 (a-19)\n\n25.4 The EHR module should incorporate configurable, role-based clinical decision support tools capable of allowing authorized personnel to trigger electronic interventions based on liked reference information standardized to Health Level 7 (HL7) Version 3 implementation guides. The reference information should be sourced.\n\n\n45 CFR Part 170.315 (a-13)\n\n25.5 The EHR module should be able to identify education resources specific to a patient's active problem and medication lists. The educational resources should be standardized to Health Level 7 (HL7) Version 3 implementation guides.\n\n\n45 CFR Part 170.315 (b-1\u2013b-2; b-4\u2013b-5)\n\n25.6 The EHR module should allow authorized personnel to create, view, send, and receive transition of care or referral summaries in such a way that the summary is properly formatted, matched to the correct patient, and reconciled according to the standards and protocols outlined in 45 CFR Part 170.315 (b-1), (b-2), (b-4), and (b-5).\n\n\n45 CFR Part 170.315 (b-3)\n\n25.7 The EHR module should allow authorized personnel to conduct electronic prescribing actions such as creating, changing, cancelling, and refilling prescriptions, incorporating at least the RxNorm and NCPDP SCRIPT standards.\n\n\n45 CFR Part 170.315 (b-6)\n\n25.8 The EHR module should allow authorized personnel to configure, create, and store data exports, incorporating at least HL7 Version 3 implementation standards, as well as SNOMED CT and ICD-9 standards.\n\n\n45 CFR Part 170.315 (b-7\u2013b-8)\n\n25.9 The EHR module should allow for the secure creation, sending, and receipt of restricted summary records, incorporating HL7 Version 3 implementation standards.\n\n\n45 CFR Part 170.315 (b-9)\n\n25.10 The EHR module should allow authorized personnel to create, record, change, access, and receive care plan information, incorporating HL7 Version 3 implementation standards.\n\n\n45 CFR Part 170.315 (c)\n\n25.11 The EHR module should provide a means to record, calculate, import, export, filter, and report on clinical quality measures according to the standards outlined in 45 CFR Part 170.315 (c).\n\n\n45 CFR Part 170.315 (d)\n\n25.12 The EHR module shall provide security and access controls for protecting stored data.\n\n\n45 CFR Part 170.315 (d)\n\n25.13 The EHR module shall record an audit trail for each and every record created and modified, using version control.\n\n\n45 CFR Part 170.315 (d-7)\n\n25.14 The EHR module shall either encrypt electronic health information on end-user devices after use of the technology on the device stops or prevent electronic health information from being stored on end-user devices after use of the technology on the device stops.\n\n\n45 CFR Part 170.315 (d-8)\n\n25.15 The EHR module shall ensure that electronically exchanged health information has not been altered during the transfer process, using at least a hashing algorithm secured to SHA-2 or better.\n\n\n45 CFR Part 170.315 (d-11)\n\n25.16 The EHR module should be capable of recording patient disclosures made for treatment, payment, and health care operations.\n\n\n45 CFR Part 170.315 (e-1)\n\n25.17 The EHR module should provide a means for patients and their authorized representatives to view, download, and transmit their personal health information and activity history log from the EHR via an internet-based technology, using the standards outlined in 45 CFR Part 170.315 (e-1).\n\n\n45 CFR Part 170.315 (e-2\u2013e-3)\n\n25.18 The EHR module should provide a means for authorized users to securely send messages to and receive messages from patients, at the same time allowing for the recording, accessing, and linking of information shared by the patient electronically (as well as directly).\n\n\n45 CFR Part 170.315 (f)\n\n25.19 The EHR module should allow vital patient information as it relates to public health to be transmitted to immunization registries, cancer registries, and public health agencies, as well as be accessed after the fact. This includes, but is not limited to, immunization history, surveillance information, laboratory test results, cancer case information, case reports, antimicrobial reporting, and health care survey information.\n\n\n45 CFR Part 170.315 (g-3\u2013g-5)\n\n25.20 The EHR developer should use user-centered and accessibility-centered design processes for creating and testing the EHR's functionality. A quality management system should be used during these processes.\n\n\n45 CFR Part 170.315 (g-6)\n\n25.21 The EHR module's use of clinical document architecture (CDA) should be demonstrated and verified for conformance to the standards identified in 45 CFR Part 170.315 (g-6).\n\n\n45 CFR Part 170.315 (g-7\u2013g-9)\n\n25.22 The EHR module should include an application programming interface (API) that demonstrates the EHR's ability to uniquely identify a patient and corresponding ID\/token in a received records or data category request in order to accurately and securely meet the request for that patient's data. The API should be well documented.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#22._Clinical_and_public_health_data_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#22._Clinical_and_public_health_data_management<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 2 May 2022, at 20:54.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2,200 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","16390a68203fc9b7cc3f655664554328_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Specialty_Laboratory_Functions rootpage-LII_LIMSpec_Specialty_Laboratory_Functions skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Specialty Laboratory Functions<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover the specialty requirements that come with working in specific industries such as agriculture, pharmaceutical production, and <a href=\"https:\/\/www.limswiki.org\/index.php\/Forensic_science\" title=\"Forensic science\" class=\"wiki-link\" data-key=\"415d36a7b65494677b6d2873d5febec1\">forensic science<\/a>. You'll likely notice that most of the content here isn't covered by <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a>.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"17._Production_management\">17. Production management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.103\" target=\"_blank\">21 CFR Part 211.103<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40 (d)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.4 and 16.20<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.1<\/b> The system should be able to calculate and record theoretical and actual percentage of yield at various phases of processing, manufacturing, and packaging.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.103\" target=\"_blank\">21 CFR Part 211.103<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.2<\/b> The system should provide a means for verification and approval of yield calculations before release for reporting.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.20\" target=\"_blank\">21 CFR Part 820.20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.186\" target=\"_blank\">21 CFR Part 820.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 1.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.3<\/b> The system shall be able to maintain a production facility's quality system in a specific quality system record, in accordance with regulations and guidance such as 21 CFR Part 820.20 and 820.40 (U.S.), E.U. Commission Directive 2003\/94\/EC Article 11 (E.U.), and WHO Technical Report Series, #986, Annex 2, 1.0 (global).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.30\" target=\"_blank\">21 CFR Part 820.30<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (e)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.4<\/b> The system shall be able to create a design control document capable of recording the details surrounding device development, including control number, physical and performance requirements, final output, review, verification, approval, transfer, changes, and complete design history.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.181\" target=\"_blank\">21 CFR Part 820.181<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.184\" target=\"_blank\">21 CFR Part 820.184<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.5<\/b> The system shall be able to create a device master and device history record capable of recording all information described in 21 CFR Part 820.181 and 820.184.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.255\u2013260<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.130\" target=\"_blank\">21 CFR Part 211.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.134\" target=\"_blank\">21 CFR Part 211.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.20\" target=\"_blank\">21 CFR Part 211.20 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.50\" target=\"_blank\">21 CFR Part 211.50 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.202\" target=\"_blank\">21 CFR Part 225.202<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.60\" target=\"_blank\">21 CFR Part 820.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 2 and 4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f\u2013g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.25\u201330<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.6<\/b> The system shall be able to create a batch production record capable of recording complete information regarding batch production and control details such as, but not limited to, a unique batch, lot, or production run number; formulation; specific labeling and packaging; production steps; in-process and laboratory control results; the unique identifier of any equipment used; persons performing and\/or supervising operational steps; and the results of any pre-process or post-production inspections.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.205\u2013210<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.186\" target=\"_blank\">21 CFR Part 211.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.22\u201323<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.7<\/b> The system shall be able to create a master production and control record capable of recording complete information regarding master production and control details.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.150 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.186\" target=\"_blank\">21 CFR Part 211.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 10.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.8<\/b> The system shall require a new or modified master production and control record to be validated, reviewed, and approved before being implemented into production, including allowing that record to be electronically signed by one or more authorized individuals upon approval. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.150 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.22\" target=\"_blank\">21 CFR Part 211.22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.75\" target=\"_blank\">21 CFR Part 820.75<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b, f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.9<\/b> The system shall require a new or modified production and control record to be validated, reviewed, and approved before being implemented in production. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 14.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.10<\/b> The system shall be able to indicate if a sample consists of an in-process manufacturing material and track characteristics of the in-process material such as identity, strength, quality, purity, and approval status.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.11<\/b> The system shall provide a means to track the amount of time between production processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (f-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c) and (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.60\" target=\"_blank\">21 CFR Part 820.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.5.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 14.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.32\u201333<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.12<\/b> The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, certificates of conformity, shelf life or expiration date, storage location, status of examination, and status of approval for use. Any related specifications for those materials should be able to be linked to the received materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.125\" target=\"_blank\">21 CFR Part 211.125 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.7 and 14.22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.35<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.13<\/b> The system shall be capable of recording the changing quantity of inventoried non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, labeling, containers, and packaging materials), including batch and lot numbers and, if applicable, details of disposition after completion of production.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.113<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.125\" target=\"_blank\">21 CFR Part 211.125 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (d\u2013e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.90\" target=\"_blank\">21 CFR Part 820.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.160\" target=\"_blank\">21 CFR Part 820.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 23<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.4, 14.26, and 14.28<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.44\u201345<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.36<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.18\u201319<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.14<\/b> The system shall prevent the internal release for distribution of a completed production batch until an authorized individual has determined the batch's conformance to final specifications and has approved it for release. If a batch is nonconforming, the system shall be able to clearly document it as such (so as to not distribute it) and provide a review and disposition process. Such approval, rejection, review, and disposition activities shall be documented.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\/subpart-C\" target=\"_blank\">21 CFR Part 7 Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.139<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.38<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\/subpart-B\" target=\"_blank\">21 CFR Part 810 Subpart B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 15.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 6.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.32<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.15<\/b> The system shall provide a means to track and record recall activities of manufactured product and devices based on lot, batch, or other identifier, including storage location, necessary disposition details, and reconciliation between distributed and recovered quantities.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.520<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.165\" target=\"_blank\">21 CFR Part 211.165 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.204\" target=\"_blank\">21 CFR Part 211.204<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.71\" target=\"_blank\">21 CFR Part 212.71 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.90\" target=\"_blank\">21 CFR Part 820.90 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.29\u201330<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.16<\/b> The system should allow a completed production batch that has been rejected for use or a returned production batch to be flagged in the system for reprocessing or reworking if it meets relevant criteria.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.145<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 4.11.8.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, I - FSM 19.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 11.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.17<\/b> The system shall support environmental testing protocols for testing the production environment on a scheduled, reportable basis. That support shall include facility and sampling site management functionality that allows for highlighting specific test points in the facility, as well as support for offsite and randomized testing. The system should also allow associated samples, methods, tests, reports, and other documents to clearly indicate they correspond to specific environmental testing protocols.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"18._Statistical_trending_and_control_charts\">18. Statistical trending and control charts<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.7.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-10-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>18.1<\/b> The system should allow authorized users to configure the generation of statistical trending and control charts.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.7.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-10-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>18.2<\/b> The system should allow authorized users to choose specific sample types, tests, and parameters associated with the statistical trending and control charts that can be generated.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"19._Agriculture_and_food_data_management\">19. Agriculture and food data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/orapartners.fda.gov\/cs\/groups\/public\/documents\/document\/b2hh\/bmri\/~edisp\/rpohandbook.pdf\" target=\"_blank\">FDA Office of Regulatory Affairs Data Exchange (ORA DX) Program<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.1<\/b> The system should be able to create or convert an XML or XLS file to ORA DX template specifications, including the use of ORA DX terminology.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.2<\/b> The system shall allow for the assignment of the \"regulatory sample collection\" role and be able to produce a list of individuals in said role, including information such as name, locations assigned, part- or full-time role, and full-time equivalents (if any) used to meet any regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.3<\/b> The system shall allow for the documentation of sampling sites used for normal and regulatory sampling and be able to produce a complete list of such sites on-demand. The documentation should allow for details such as the addition of a unique, never-before-used site code; a region code; demographics; date added to or removed from the system; facility type; sample substrates or commodities available at the site; and relative volume information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.4.12 and 5.4.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.4<\/b> The system shall allow a site that is no longer active for sampling purposes be designated as inactive, yet be allowed to remain on any generated master list. Additionally, such inactive site shall maintain its unique site number in the event the site becomes reinstated as active.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.130\u2013135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507, Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.2, 3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - HACCP 1.X<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 2.2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 2.2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>19.5<\/b> The system shall allow for the development and documentation of hazard analysis and critical control points (HACCP) or other regulatory-driven food safety plan steps, as well as the implementation of those CCPs or steps into configurable laboratory workflow.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.6<\/b> The system shall require a new or modified HACCP or other regulatory-driven food safety plan be validated, reviewed, and approved before being implemented, including requiring that plan to be electronically signed by one or more authorized individuals upon approval.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.92<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>19.7<\/b> The system shall allow for the documentation and management of internal and external audit activities, while allowing samples, methods, tests, results, reports, documents, and more to be clearly associated with that corresponding audit activity.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"20._Environmental_data_management\">20. Environmental data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/geospatial\/epa-metadata-technical-specification\" target=\"_blank\">EPA Metadata Technical Specification<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.1<\/b> The system should support metadata requirements set forth by ISO 19115 and the EPA Metadata Technical Specification for reporting and data publishing purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.2<\/b> The system should support the manual entry or electronic transfer of EPA analytical service requests (ASRs), along with all the required fields of the ASR, including project identifier, project demographics, sample specifics, sample hazards, reporting requirements, and special requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/2015-07\/documents\/sedd52_specification.pdf\" target=\"_blank\">EPA SEDD Specification and Data Element Dictionary v5.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.3<\/b> The system should support the creation and transfer of Staged Electronic Data Deliverable (SEDD) files.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.10\" target=\"_blank\">40 CFR Part 3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/60\" target=\"_blank\">40 CFR Part 60 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/62\" target=\"_blank\">40 CFR Part 62 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/63\" target=\"_blank\">40 CFR Part 63 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>20.4<\/b> The system shall support generating electronic environmental reports (e.g., stationary source emissions tests) in either the EPA's Electronic Reporting Tool (ERT) special spreadsheet format or in an XML file format that complies with EPA-approved XML schema.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/denix.osd.mil\/edqw\/documents\/documents\/gen-data-validation-rev1\/\" target=\"_blank\">DoD General Data Validation Guidelines<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.5<\/b> The system should support electronic data deliverable (EDD) validation by linking the EDD to its quality assurance project plan (QAPP) and the appropriate stage of validation for the EDD's data type.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"21._Forensic_case_and_data_management\">21. Forensic case and data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.4.3<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1459-13 2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 4.1.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 4.1.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 4.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.1<\/b> The system shall be able to assign each piece of collected evidence and each scene a unique identifier using methodologies such as an ID with an incrementing integer (for sequential evidence numbers) or a user-defined naming format for meeting regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.6\u201310<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.2<\/b> The system shall be able to assign each case a unique case identifier that, in addition to an electronic signature, is able to be automatically placed on, at a maximum, each page of the case's associated examination and administration records.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.5.1.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.3<\/b> In addition to a unique case number, the system shall provide a means to add additional information to a case file, including, but not limited to, submitting agency, agency case number, date of case receipt, name of recipient, shipping and receipt details, items associated with the case and their unique designators, notes, test data, related reports, and other documentation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 (throughout)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 (throughout)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.4.3 and 4.5.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.4<\/b> The system should be able to document evidence using an ASTM-compliant evidence log, including, but not limited to, unique identifiers, investigator and custodian names, key dates and times, evidence conditions, and storage location.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.1.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.5<\/b> The system should be able to prevent a piece of evidence from being scheduled for destructive testing until an appropriate authorization for such analysis is acquired and documented.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.6<\/b> The system shall be able to record and maintain chain of custody of evidence that is subdivided in the laboratory in the same way that original evidence items are tracked.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.1.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.7<\/b> The system shall be capable of recording the secondary dissemination to an authorized agency or organization of criminal history record information (CHRI) sourced from U.S. Criminal Justice Information Services (CJIS).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.8<\/b> The system shall be able to record all National Crime Information Center (NCIC) and Interstate Identification Index (III) data transactions, clearly identifying the operator and authorized receiving agency or organization. III records shall also identify requester and recipient using a unique identifier.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(1) <\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.9<\/b> If the system provides remote access to authorized users over authorized devices, the remote access shall be monitored, controlled and documented, particularly for privileged functions. If remote access to privileged functions is allowed, virtual escorting that meets CJIS Security Policy 5.5.6 conditions will be required.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.1.1.1\u20132<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.1.2\u20133<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5(1) <\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.10<\/b> The system shall be capable of putting into place, in their entirety, either the \"basic password standards\" or \"advanced password standards\" described in CJIS Security Policy 5.6.2.1.1.1 and 5.6.2.1.1.2. If PIN and\/or one-time password is also used, the attributes in 5.6.2.1.2 and 5.6.2.1.3 shall also be required.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.11<\/b> If the system supports user-based certificates for authentication, the system shall be configurable enough to require them to be 1. user-specific, not device-specific, 2. used only by one user at any given time, and 3. activated for each use by, e.g., a passphrase or PIN.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2.1\u20132<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(2) <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-13, SC-28, and SC-28(1)<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.12<\/b> The system shall allow \"encryption in transit\" and \"encryption at rest\" of criminal justice information (CJI) that meets or exceeds the requirements of CJIS Security Policy 5.10.1.2.1 and 5.10.1.2.2.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.13<\/b> If the system is cloud-based, the vendor shall ensure that CJI is stored in databases located within the physical boundaries of APB-member countries and within the legal authority of APB-member agencies. Additionally, the vendor shall agree to not use any metadata derived from unencrypted CJI for commercial, advertising, or other purposes, unless specifically permitted for limited within the service agreement.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.11.1\u20132<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.14<\/b> If the system is cloud-based, the vendor should agree to FBI and CSA compliance and security audits of CJI.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.3.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.15<\/b> If the system is capable of being run in a virtual environment, it shall meet the virtualization requirements set forth in CJIS Security Policy 5.10.3.2 and best practices set forth in CJIS Security Policy Appendix G.1.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6(4)<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-39<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.16<\/b> The system should provide separate processing domains in order to not only allow for more granular allocation of user privileges, but also to prevent one process from modifying the executing code of another process.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2(1\u20132), IA-2(12), and IA-8(1)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.17<\/b> The system should support the use of personal identity verification\u2014a U.S. Federal government-wide credential system\u2014and other forms of hardware-based (i.e., public key infrastructure or PKI) token authentication, while electronically verifying those credentials and any configured token quality requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.18<\/b> The system should support the identification and tagging of infrequently performed forensic tests or analyses in order to alert the analyst and other stakeholders that additional competency verification or method validation is required before performing the test or analysis.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.19<\/b> The system should allow case records to be scheduled for periodic administrative and technical review by individuals not connected with the case. The conducted review should indicate details such as who conducted the review, what the results were, and when the review was completed. If non-conforming results were discovered, records of determination and resolution should be appended to the case record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.20<\/b> The system should be able to document examiner testimony and allow such testimony to be scheduled for periodic evaluation. The conducted evaluation should indicate details such as who conducted the evaluation, what the results were, and when the review was completed. If non-conforming results were discovered, related records of determination and resolution should be maintained in the system.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"22._Clinical_and_public_health_data_management\">22. Clinical and public health data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/phin\/tools\/phinms\/index.html\" target=\"_blank\">CDC PHIN Messaging System<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.1<\/b> The system should be capable of interfacing with the Center for Disease Control and Prevention's PHIN Messaging System.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.5<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>22.2<\/b> The system should support Human Genome Variation Society (HGVS) nomenclature and terminology for sequence variants.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.3<\/b> The system should be able to collect sufficient test utilization information to make necessity checks on ordered tests against established benchmarks.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healthit.gov\/isa\/united-states-core-data-interoperability-uscdi\" target=\"_blank\">ONC USCDI v2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.4<\/b> The system should support the United States Core Data for Interoperability (USCDI) v2 standard, which in turn supports data interoperability across multiple clinical settings.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"23._Veterinary_data_management\">23. Veterinary data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphis.usda.gov\/aphis\/ourfocus\/animalhealth\/lab-info-services\/nahln\/ct_nahln_it\" target=\"_blank\">NAHLN Information Technology System<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/venomcoding.org\/\" target=\"_blank\">VeNom Coding Group<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vtsl.vetmed.vt.edu\/\" target=\"_blank\">Veterinary Terminology Services Laboratory<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.1<\/b> The system should support standardized veterinary clinical terminology such as that found in the Veterinary Extension of SNOMED CT and the Veterinary Nomenclature (VeNom) Codes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.icar.org\/Guidelines\/15-Data-Exchange.pdf\" target=\"_blank\">ICAR 15 Data Exchange<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vichsec.org\/en\/guidelines\/general\" target=\"_blank\">VICH GL53<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.2<\/b> The system should be able to exchange data, when necessary, in a fashion that meets International Committee for Animal Recording (ICAR) and Veterinary International Conference on Harmonization (VICH) electronic data exchange guidelines.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphis.usda.gov\/animal_health\/nahln\/downloads\/MessagingQuickGuide.pdf\" target=\"_blank\">NAHLN HL7 Messaging Quick User Guide<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.3<\/b> The system should support National Animal Health Laboratory Network (NAHLN), and, by extension, Health Level 7 (HL7) result messaging.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"24._Scientific_data_management\">24. Scientific data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.1<\/b> The system shall capture raw instrument data and metadata either as an electronic file or directly via RS-232 or TCP\/IP communication.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.2<\/b> The scientific data management system (SDMS) should provide a checksum verification of source and destination data and store that verification data in a secure server with controlled access.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.3<\/b> The system shall store metadata related to raw instrument data in a database in such a way that the original data generated by instruments for specific samples and tests is easy to retrieve.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.4<\/b> The system should be capable of capturing a complete and readable copy of original data and any previous versions of modified data in order to maintain the integrity of that data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD AAVLD Requirements for an AVMDL Sec. 4.10.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.5<\/b> The system should secure raw data such that it can't be deleted and provide version control when data is modified by any user or specific software.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.6<\/b> The SDMS should provide tools for helping a laboratory achieve the U.S. Food and Drug Administration's defined ALCOA principles.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.7<\/b> The SDMS shall provide security and access controls for protecting stored data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.8<\/b> The SDMS shall record an audit trail for each and every record created and modified, using version control.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.9<\/b> The SDMS shall provide proper systems for backing up, restoring, and archiving data for long-term use.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"25._Health_information_technology\">25. Health information technology<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-1\u2013a-4)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.1<\/b> The electronic health record (EHR) module should provide computerized provider order entry (CPOE) functionality for medication orders, laboratory orders, and diagnostic imaging, including making checks for potential drug-drug and drug-allergy interactions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-5)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-11\u2013a-12)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-15)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.2<\/b> The EHR module should allow authorized personnel to record, change, and access patient demographic data, including, but not limited to, race and ethnicity, patient's preferred language, birth sex, current sex, sexual orientation, gender identity, birth date, smoking status, alcohol use, family health history, psychological aspects, social aspects, and behavioral aspects.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-6\u2013a-8)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-10)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-14)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.3<\/b> The EHR module should allow authorized personnel to record, change, and access a patient's active problem list, medication list, medication allergy list, preferred drug list, and implantable device list, incorporating, where appropriate, at a minimum the SNOMED CT nomenclature standard.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-19)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.4<\/b> The EHR module should incorporate configurable, role-based clinical decision support tools capable of allowing authorized personnel to trigger electronic interventions based on liked reference information standardized to Health Level 7 (HL7) Version 3 implementation guides. The reference information should be sourced.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-13)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.5<\/b> The EHR module should be able to identify education resources specific to a patient's active problem and medication lists. The educational resources should be standardized to Health Level 7 (HL7) Version 3 implementation guides.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-1\u2013b-2; b-4\u2013b-5)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.6<\/b> The EHR module should allow authorized personnel to create, view, send, and receive transition of care or referral summaries in such a way that the summary is properly formatted, matched to the correct patient, and reconciled according to the standards and protocols outlined in 45 CFR Part 170.315 (b-1), (b-2), (b-4), and (b-5).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.7<\/b> The EHR module should allow authorized personnel to conduct electronic prescribing actions such as creating, changing, cancelling, and refilling prescriptions, incorporating at least the RxNorm and NCPDP SCRIPT standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-6)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.8<\/b> The EHR module should allow authorized personnel to configure, create, and store data exports, incorporating at least HL7 Version 3 implementation standards, as well as SNOMED CT and ICD-9 standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-7\u2013b-8)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.9<\/b> The EHR module should allow for the secure creation, sending, and receipt of restricted summary records, incorporating HL7 Version 3 implementation standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-9)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.10<\/b> The EHR module should allow authorized personnel to create, record, change, access, and receive care plan information, incorporating HL7 Version 3 implementation standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (c)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.11<\/b> The EHR module should provide a means to record, calculate, import, export, filter, and report on clinical quality measures according to the standards outlined in 45 CFR Part 170.315 (c).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.12<\/b> The EHR module shall provide security and access controls for protecting stored data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.13<\/b> The EHR module shall record an audit trail for each and every record created and modified, using version control.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.14<\/b> The EHR module shall either encrypt electronic health information on end-user devices after use of the technology on the device stops or prevent electronic health information from being stored on end-user devices after use of the technology on the device stops.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-8)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.15<\/b> The EHR module shall ensure that electronically exchanged health information has not been altered during the transfer process, using at least a hashing algorithm secured to SHA-2 or better.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-11)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.16<\/b> The EHR module should be capable of recording patient disclosures made for treatment, payment, and health care operations.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (e-1)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.17<\/b> The EHR module should provide a means for patients and their authorized representatives to view, download, and transmit their personal health information and activity history log from the EHR via an internet-based technology, using the standards outlined in 45 CFR Part 170.315 (e-1).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (e-2\u2013e-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.18<\/b> The EHR module should provide a means for authorized users to securely send messages to and receive messages from patients, at the same time allowing for the recording, accessing, and linking of information shared by the patient electronically (as well as directly).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (f)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.19<\/b> The EHR module should allow vital patient information as it relates to public health to be transmitted to immunization registries, cancer registries, and public health agencies, as well as be accessed after the fact. This includes, but is not limited to, immunization history, surveillance information, laboratory test results, cancer case information, case reports, antimicrobial reporting, and health care survey information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-3\u2013g-5)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.20<\/b> The EHR developer should use user-centered and accessibility-centered design processes for creating and testing the EHR's functionality. A quality management system should be used during these processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-6)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.21<\/b> The EHR module's use of clinical document architecture (CDA) should be demonstrated and verified for conformance to the standards identified in 45 CFR Part 170.315 (g-6).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-7\u2013g-9)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.22<\/b> The EHR module should include an application programming interface (API) that demonstrates the EHR's ability to uniquely identify a patient and corresponding ID\/token in a received records or data category request in order to accurately and securely meet the request for that patient's data. The API should be well documented.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173544\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.091 seconds\nReal time usage: 0.100 seconds\nPreprocessor visited node count: 377\/1000000\nPost\u2010expand include size: 77243\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 20.131 1 -total\n 12.96% 2.609 1 Template:LIMSpec\/Production_management\n 11.73% 2.361 1 Template:LIMSpec\/Environmental_data_management\n 11.17% 2.248 1 Template:LIMSpec\/Veterinary_data_management\n 11.10% 2.234 1 Template:LIMSpec\/Health_information_technology\n 10.88% 2.191 1 Template:LIMSpec\/Scientific_data_management\n 9.85% 1.984 1 Template:LIMSpec\/Public_health_data_management\n 9.80% 1.973 1 Template:LIMSpec\/Forensic_case_and_data_management\n 9.37% 1.887 1 Template:LIMSpec\/Agriculture_and_food_data_management\n 9.11% 1.833 1 Template:LIMSpec\/Statistical_trending_and_control_charts\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11203-0!canonical and timestamp 20221202173544 and revision id 47561. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#22._Clinical_and_public_health_data_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#22._Clinical_and_public_health_data_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","16390a68203fc9b7cc3f655664554328_images":[],"16390a68203fc9b7cc3f655664554328_timestamp":1670002544,"5f931466bb9436d113fc17a04bc496cf_type":"article","5f931466bb9436d113fc17a04bc496cf_title":"21. Forensic case and data management","5f931466bb9436d113fc17a04bc496cf_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#21._Forensic_case_and_data_management","5f931466bb9436d113fc17a04bc496cf_plaintext":"\n\nLII:LIMSpec\/Specialty Laboratory FunctionsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover the specialty requirements that come with working in specific industries such as agriculture, pharmaceutical production, and forensic science. You'll likely notice that most of the content here isn't covered by ASTM E1578-18.\n\n17. Production management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 211.103\r\n21 CFR Part 226.40 (d)\r\nWHO Technical Report Series, #986, Annex 2, 16.4 and 16.20\n\n17.1 The system should be able to calculate and record theoretical and actual percentage of yield at various phases of processing, manufacturing, and packaging.\n\n\n21 CFR Part 211.103\n\n17.2 The system should provide a means for verification and approval of yield calculations before release for reporting.\n\n\n\n21 CFR Part 820.20\r\n\n21 CFR Part 820.40\r\n\n21 CFR Part 820.186\r\n\nE.U. Commission Directive 2003\/94\/EC Article 11\r\n\nWHO Technical Report Series, #986, Annex 2, 1.0\n\n\n17.3 The system shall be able to maintain a production facility's quality system in a specific quality system record, in accordance with regulations and guidance such as 21 CFR Part 820.20 and 820.40 (U.S.), E.U. Commission Directive 2003\/94\/EC Article 11 (E.U.), and WHO Technical Report Series, #986, Annex 2, 1.0 (global).\n\n\n21 CFR Part 820.30\r\n21 CFR Part 820.120 (e)\n\n17.4 The system shall be able to create a design control document capable of recording the details surrounding device development, including control number, physical and performance requirements, final output, review, verification, approval, transfer, changes, and complete design history.\n\n\n21 CFR Part 820.181\r\n21 CFR Part 820.184\n\n17.5 The system shall be able to create a device master and device history record capable of recording all information described in 21 CFR Part 820.181 and 820.184.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 111.255\u2013260\r\n\n21 CFR Part 114.100 (b)\r\n\n21 CFR Part 211.105 (b)\r\n\n21 CFR Part 211.130 (e)\r\n\n21 CFR Part 211.134 (c)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.20 (d)\r\n\n21 CFR Part 211.50 (c)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 225.202\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 820.60\r\n\n21 CFR Part 820.70 (a)\r\n\n21 CFR Part 820.80 (c)\r\n\n21 CFR Part 820.120 (d)\r\n\nBRC GSFS, Issue 8, 6.1.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.1.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 8.1\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.1\r\n\nFDA Hazard Analysis Critical Control Point Principle 2 and 4\r\n\nFDA Hazard Analysis Critical Control Point Principle 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11\r\n\nIFS Food 7, Part 2, 4.2.1.1\r\n\nIFS Food 7, Part 2, 4.18.1\r\n\nIFS PACsecure 2, Part 2, 4.2.1.1\r\n\nIFS PACsecure 2, Part 2, 4.18.1\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (3)\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f\u2013g)\r\n\nWHO Technical Report Series, #986, Annex 2, 15.25\u201330\n\n\n17.6 The system shall be able to create a batch production record capable of recording complete information regarding batch production and control details such as, but not limited to, a unique batch, lot, or production run number; formulation; specific labeling and packaging; production steps; in-process and laboratory control results; the unique identifier of any equipment used; persons performing and\/or supervising operational steps; and the results of any pre-process or post-production inspections.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.100 (e)\r\n\n21 CFR Part 111.205\u2013210\r\n\n21 CFR Part 114.100 (b)\r\n\n21 CFR Part 211.186\r\n\n21 CFR Part 212.50 (b)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nBRC GSFS, Issue 8, 3.6.2\r\n\nBRC GSFS, Issue 8, 9.2.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.1.2\r\n\nFDA Hazard Analysis Critical Control Point Principle 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11\r\n\nIFS Food 7, Part 2, 4.2.1.1\r\n\nIFS PACsecure 2, Part 2, 4.2.1.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 15.22\u201323\n\n\n17.7 The system shall be able to create a master production and control record capable of recording complete information regarding master production and control details.\n\n\n\n21 CFR Part 106.100 (e)\r\n\n21 CFR Part 111.123 (a)\r\n\n21 CFR Part 114.100 (c)\r\n\n21 CFR Part 117.150 (d)\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.186\r\n\n21 CFR Part 212.50 (b)\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nBRC GSFS, Issue 8, 9.2.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 10.3\u20134\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.2\r\n\nIFS Food 7, Part 2, 4.2.1.2\r\n\nIFS Food 7, Part 2, 4.3.x\r\n\nIFS Food 7, Part 2, 5.11\r\n\nIFS PACsecure 2, Part 2, 4.2.1.2\r\n\nIFS PACsecure 2, Part 2, 4.3.x\r\n\nIFS PACsecure 2, Part 2, 5.11\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b)\r\n\nWHO Technical Report Series, #986, Annex 2, 4.0\n\n\n17.8 The system shall require a new or modified master production and control record to be validated, reviewed, and approved before being implemented into production, including allowing that record to be electronically signed by one or more authorized individuals upon approval. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n\n\n\n21 CFR Part 111.123 (a)\r\n\n21 CFR Part 114.100 (c)\r\n\n21 CFR Part 117.150 (d)\r\n\n21 CFR Part 211.22\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 820.70 (b)\r\n\n21 CFR Part 820.75\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 10.3\r\n\nIFS Food 7, Part 2, 4.2.1.2\r\n\nIFS Food 7, Part 2, 4.3.x\r\n\nIFS Food 7, Part 2, 5.11\r\n\nIFS PACsecure 2, Part 2, 4.2.1.2\r\n\nIFS PACsecure 2, Part 2, 4.3.x\r\n\nIFS PACsecure 2, Part 2, 5.11\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b, f)\r\n\nWHO Technical Report Series, #986, Annex 2, 4.0\n\n\n17.9 The system shall require a new or modified production and control record to be validated, reviewed, and approved before being implemented in production. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n\n\n\n21 CFR Part 211.110\r\n\n21 CFR Part 212.50\r\n\n21 CFR Part 820.80 (c)\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\r\n\nISO\/TS 22002-1:2009, 14.3\n\n\n17.10 The system shall be able to indicate if a sample consists of an in-process manufacturing material and track characteristics of the in-process material such as identity, strength, quality, purity, and approval status.\n\n\n21 CFR Part 211.111\n\n17.11 The system shall provide a means to track the amount of time between production processes.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.80\r\n\n21 CFR Part 106.100 (f-6)\r\n\n21 CFR Part 117.420\r\n\n21 CFR Part 211.122 (c)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 212.20 (b)\r\n\n21 CFR Part 212.40 (c) and (e)\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.40 (b)\r\n\n21 CFR Part 226.42\r\n\n21 CFR Part 606.120 (b)\r\n\n21 CFR Part 820.60\r\n\n21 CFR Part 820.80 (b)\r\n\n21 CFR Part 820.120 (b)\r\n\nBRC GSFS, Issue 8, 3.6.1\r\n\nBRC GSFS, Issue 8, 3.9.2\r\n\nBRC GSFS, Issue 8, 5.4.4\r\n\nBRC GSFS, Issue 8, 3.5.1\r\n\nBRC GSFS, Issue 8, 9.5.1\u20132\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17\r\n\nIFS Food 7, Part 2, 4.5.2\r\n\nIFS Food 7, Part 2, 4.18.1\r\n\nIFS PACsecure 2, Part 2, 4.5.2\r\n\nIFS PACsecure 2, Part 2, 4.18.1\r\n\nISO\/TS 22002-1:2009, 9.3\r\n\nISO\/TS 22002-1:2009, 14.2\r\n\nISO\/TS 22002-4:2013, 4.6.3\r\n\nISO\/TS 22002-4:2013, 4.11.2\r\n\nISO\/TS 22002-6:2016, 4.6.3\r\n\nISO\/TS 22002-6:2016, 4.11.2\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nWHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21\r\n\nWHO Technical Report Series, #986, Annex 2, 15.32\u201333\n\n\n17.12 The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, certificates of conformity, shelf life or expiration date, storage location, status of examination, and status of approval for use. Any related specifications for those materials should be able to be linked to the received materials.\n\n\n\n21 CFR Part 211.122 (e)\r\n\n21 CFR Part 211.125 (d)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.42\r\n\nBRC GSFS, Issue 8, 3.5.3\r\n\nBRC GSFS, Issue 8, 9.5.3\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17\r\n\nWHO Technical Report Series, #986, Annex 2, 14.7 and 14.22\r\n\nWHO Technical Report Series, #986, Annex 2, 16.35\n\n\n17.13 The system shall be capable of recording the changing quantity of inventoried non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, labeling, containers, and packaging materials), including batch and lot numbers and, if applicable, details of disposition after completion of production.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.70\r\n\n21 CFR Part 111.113\r\n\n21 CFR Part 111.123 (b)\r\n\n21 CFR Part 114.100 (d)\r\n\n21 CFR Part 120.10\r\n\n21 CFR Part 123.6\r\n\n21 CFR Part 211.122 (e)\r\n\n21 CFR Part 211.125 (d)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.42\r\n\n21 CFR Part 606.100 (c)\r\n\n21 CFR Part 820.80 (d\u2013e)\r\n\n21 CFR Part 820.90\r\n\n21 CFR Part 820.160\r\n\nBRC GSFS, Issue 8, 3.8.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.2\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 23\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\nIFS Food 7, Part 2, 5.7.1\r\n\nIFS Food 7, Part 2, 5.10\r\n\nIFS PACsecure 2, Part 2, 5.7.1\r\n\nIFS PACsecure 2, Part 2, 5.10\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.5\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.7\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.5\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.7\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.5\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.7\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (g)\r\n\nWHO Technical Report Series, #986, Annex 2, 14.4, 14.26, and 14.28\r\n\nWHO Technical Report Series, #986, Annex 2, 15.44\u201345\r\n\nWHO Technical Report Series, #986, Annex 2, 16.36\r\n\nWHO Technical Report Series, #986, Annex 2, 17.18\u201319\n\n\n17.14 The system shall prevent the internal release for distribution of a completed production batch until an authorized individual has determined the batch's conformance to final specifications and has approved it for release. If a batch is nonconforming, the system shall be able to clearly document it as such (so as to not distribute it) and provide a review and disposition process. Such approval, rejection, review, and disposition activities shall be documented.\n\n\n\n21 CFR Part 7 Subpart C\r\n\n21 CFR Part 117.139\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 507.38\r\n\n21 CFR Part 810 Subpart B\r\n\nBRC GSFS, Issue 8, 3.11.2\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.5\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\nIFS Food 7, Part 2, 5.9.2\r\n\nIFS PACsecure 2, Part 2, 5.9.2\r\n\nISO\/TS 22002-1:2009, 15.x\r\n\nISO\/TS 22002-4:2013, 4.12\r\n\nISO\/TS 22002-6:2016, 4.12\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.6.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.6.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.3\r\n\nWHO Technical Report Series, #986, Annex 2, 6.0\r\n\nWHO Technical Report Series, #986, Annex 2, 14.32\n\n\n17.15 The system shall provide a means to track and record recall activities of manufactured product and devices based on lot, batch, or other identifier, including storage location, necessary disposition details, and reconciliation between distributed and recovered quantities.\n\n\n\n21 CFR Part 111.520\r\n\n21 CFR Part 211.165 (f)\r\n\n21 CFR Part 211.204\r\n\n21 CFR Part 212.71 (d)\r\n\n21 CFR Part 820.90 (b-2)\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.6\r\n\nWHO Technical Report Series, #986, Annex 2, 14.29\u201330\n\n\n17.16 The system should allow a completed production batch that has been rejected for use or a returned production batch to be flagged in the system for reprocessing or reworking if it meets relevant criteria.\n\n\n\n21 CFR Part 112.145\r\n\nBRC GSFS, Issue 8, 4.11.8.x\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, I - FSM 19.2\r\n\nISO\/TS 22002-1:2009, 11.5\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.8\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.8\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.8\n\n\n17.17 The system shall support environmental testing protocols for testing the production environment on a scheduled, reportable basis. That support shall include facility and sampling site management functionality that allows for highlighting specific test points in the facility, as well as support for offsite and randomized testing. The system should also allow associated samples, methods, tests, reports, and other documents to clearly indicate they correspond to specific environmental testing protocols.\n\n\n\n18. Statistical trending and control charts \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 820.250\r\n\nAIHA-LAP Policies 2018 2A.7.7.1.3\r\n\nASTM E1578-18 E-10-1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7.2.8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.8\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 9\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\n\n\n18.1 The system should allow authorized users to configure the generation of statistical trending and control charts.\n\n\n\n21 CFR Part 820.250\r\n\nAIHA-LAP Policies 2018 2A.7.7.1.3\r\n\nASTM E1578-18 E-10-2\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7.2.8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.8\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 9\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\n\n\n18.2 The system should allow authorized users to choose specific sample types, tests, and parameters associated with the statistical trending and control charts that can be generated.\n\n\n\n19. Agriculture and food data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nFDA Office of Regulatory Affairs Data Exchange (ORA DX) Program\n\n19.1 The system should be able to create or convert an XML or XLS file to ORA DX template specifications, including the use of ORA DX terminology.\n\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\nUSDA Sampling Procedures for PDP 5.3\r\nUSDA Sampling Procedures for PDP 6.2\n\n19.2 The system shall allow for the assignment of the \"regulatory sample collection\" role and be able to produce a list of individuals in said role, including information such as name, locations assigned, part- or full-time role, and full-time equivalents (if any) used to meet any regulatory requirements.\n\n\nUSDA Sampling Procedures for PDP 5.4\n\n19.3 The system shall allow for the documentation of sampling sites used for normal and regulatory sampling and be able to produce a complete list of such sites on-demand. The documentation should allow for details such as the addition of a unique, never-before-used site code; a region code; demographics; date added to or removed from the system; facility type; sample substrates or commodities available at the site; and relative volume information.\n\n\nUSDA Sampling Procedures for PDP 5.4.12 and 5.4.14\n\n19.4 The system shall allow a site that is no longer active for sampling purposes be designated as inactive, yet be allowed to remain on any generated master list. Additionally, such inactive site shall maintain its unique site number in the event the site becomes reinstated as active.\n\n\n\n21 CFR Part 117.130\u2013135\r\n\n21 CFR Part 120 (throughout)\r\n\n21 CFR Part 123.6\r\n\n21 CFR Part 507, Subpart C\r\n\n61 FR 38806, 9 CFR Part 417.x\r\n\nBRC GSFS, Issue 8, 2.x\r\n\nCodex Alimentarius CXC 1-1969, Ch.2, 3.x\r\n\nE.U. Commission Reg. No. 852\/2004 Article 5\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - HACCP 1.X\r\n\nIFS Food 7, Part 2, 2.2.x\r\n\nIFS PACsecure 2, Part 2, 2.2.x\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.3\n\n\n19.5 The system shall allow for the development and documentation of hazard analysis and critical control points (HACCP) or other regulatory-driven food safety plan steps, as well as the implementation of those CCPs or steps into configurable laboratory workflow.\n\n\n61 FR 38806, 9 CFR Part 417.4\n\n19.6 The system shall require a new or modified HACCP or other regulatory-driven food safety plan be validated, reviewed, and approved before being implemented, including requiring that plan to be electronically signed by one or more authorized individuals upon approval.\n\n\n\n21 CFR Part 106.90\r\n\n21 CFR Part 106.92\r\n\n21 CFR Part 106.94\r\n\n21 CFR Part 106.100 (j)\r\n\nBRC GSFS, Issue 8, 3.4.x\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 20\r\n\nIFS Food 7, Part 2, 5.1\r\n\nIFS PACsecure 2, Part 2, 5.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.4\n\n\n19.7 The system shall allow for the documentation and management of internal and external audit activities, while allowing samples, methods, tests, results, reports, documents, and more to be clearly associated with that corresponding audit activity.\n\n\n\n20. Environmental data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nEPA Metadata Technical Specification\n\n20.1 The system should support metadata requirements set forth by ISO 19115 and the EPA Metadata Technical Specification for reporting and data publishing purposes.\n\n\nEPA ERLN Laboratory Requirements 3.3\n\n20.2 The system should support the manual entry or electronic transfer of EPA analytical service requests (ASRs), along with all the required fields of the ASR, including project identifier, project demographics, sample specifics, sample hazards, reporting requirements, and special requirements.\n\n\nEPA SEDD Specification and Data Element Dictionary v5.2\n\n20.3 The system should support the creation and transfer of Staged Electronic Data Deliverable (SEDD) files.\n\n\n\n40 CFR Part 3.10\r\n\n40 CFR Part 60 (throughout)\r\n\n40 CFR Part 62 (throughout)\r\n\n40 CFR Part 63 (throughout)\n\n\n20.4 The system shall support generating electronic environmental reports (e.g., stationary source emissions tests) in either the EPA's Electronic Reporting Tool (ERT) special spreadsheet format or in an XML file format that complies with EPA-approved XML schema.\n\n\nDoD General Data Validation Guidelines\n\n20.5 The system should support electronic data deliverable (EDD) validation by linking the EDD to its quality assurance project plan (QAPP) and the appropriate stage of validation for the EDD's data type.\n\n\n\n21. Forensic case and data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.4.3\nASTM E1188-11 3.2.3\r\n\nASTM E1188-11 3.4.1\r\n\nASTM E1459-13 2.1\r\n\nASTM E1459-13 4.1.1\u20132\r\n\nASTM E1459-13 4.1.4.2\r\n\nASTM E1459-13 4.2.2\u20133\r\n\nASTM E1492-11 4.1.1\r\n\nASTM E1492-11 4.1.5\n\n\n21.1 The system shall be able to assign each piece of collected evidence and each scene a unique identifier using methodologies such as an ID with an incrementing integer (for sequential evidence numbers) or a user-defined naming format for meeting regulatory requirements.\n\n\nA2LA C223 4.13\r\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.6\u201310\r\nASTM E1492-11 4.1.1\r\n\n\n21.2 The system shall be able to assign each case a unique case identifier that, in addition to an electronic signature, is able to be automatically placed on, at a maximum, each page of the case's associated examination and administration records.\n\n\n\nA2LA C223 4.13\r\n\nASTM E1492-11 4.1.1.1\u20132\r\n\nASTM E1492-11 4.1.4\u20135\r\n\nASTM E1492-11 4.2.2\u20133\r\n\nASTM E1492-11 4.5.1.1\n\n\n21.3 In addition to a unique case number, the system shall provide a means to add additional information to a case file, including, but not limited to, submitting agency, agency case number, date of case receipt, name of recipient, shipping and receipt details, items associated with the case and their unique designators, notes, test data, related reports, and other documentation.\n\n\nASTM E1188-11 (throughout)\r\nASTM E1459-13 (throughout)\r\nASTM E1492-11 4.4.3 and 4.5.1\n\n21.4 The system should be able to document evidence using an ASTM-compliant evidence log, including, but not limited to, unique identifiers, investigator and custodian names, key dates and times, evidence conditions, and storage location.\n\n\nASTM E1492-11 4.3.1.1\n\n21.5 The system should be able to prevent a piece of evidence from being scheduled for destructive testing until an appropriate authorization for such analysis is acquired and documented.\n\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1.1\r\nASTM E1492-11 4.1.2\n\n21.6 The system shall be able to record and maintain chain of custody of evidence that is subdivided in the laboratory in the same way that original evidence items are tracked.\n\n\nCJIS Security Policy 5.1.3\n\n21.7 The system shall be capable of recording the secondary dissemination to an authorized agency or organization of criminal history record information (CHRI) sourced from U.S. Criminal Justice Information Services (CJIS).\n\n\nCJIS Security Policy 5.4.7\n\n21.8 The system shall be able to record all National Crime Information Center (NCIC) and Interstate Identification Index (III) data transactions, clearly identifying the operator and authorized receiving agency or organization. III records shall also identify requester and recipient using a unique identifier.\n\n\nCJIS Security Policy 5.5.6\r\nNIST 800-53, Rev. 5, AC-17(1) \r\n\n\n21.9 If the system provides remote access to authorized users over authorized devices, the remote access shall be monitored, controlled and documented, particularly for privileged functions. If remote access to privileged functions is allowed, virtual escorting that meets CJIS Security Policy 5.5.6 conditions will be required.\n\n\nCJIS Security Policy 5.6.2.1.1.1\u20132\r\nCJIS Security Policy 5.6.2.1.2\u20133\r\nNIST 800-53, Rev. 5, IA-5(1) \r\n\n\n21.10 The system shall be capable of putting into place, in their entirety, either the \"basic password standards\" or \"advanced password standards\" described in CJIS Security Policy 5.6.2.1.1.1 and 5.6.2.1.1.2. If PIN and\/or one-time password is also used, the attributes in 5.6.2.1.2 and 5.6.2.1.3 shall also be required.\n\n\nCJIS Security Policy 5.6.2.2\n\n21.11 If the system supports user-based certificates for authentication, the system shall be configurable enough to require them to be 1. user-specific, not device-specific, 2. used only by one user at any given time, and 3. activated for each use by, e.g., a passphrase or PIN.\n\n\nCJIS Security Policy 5.10.1.2.1\u20132\r\n\nCJIS Security Policy Appendix G.6\r\n\nNIST 800-53, Rev. 5, AC-17(2) \r\n\nNIST 800-53, Rev. 5, SC-13, SC-28, and SC-28(1)\r\n\n\n\n21.12 The system shall allow \"encryption in transit\" and \"encryption at rest\" of criminal justice information (CJI) that meets or exceeds the requirements of CJIS Security Policy 5.10.1.2.1 and 5.10.1.2.2.\n\n\nCJIS Security Policy 5.10.1.5\n\n21.13 If the system is cloud-based, the vendor shall ensure that CJI is stored in databases located within the physical boundaries of APB-member countries and within the legal authority of APB-member agencies. Additionally, the vendor shall agree to not use any metadata derived from unencrypted CJI for commercial, advertising, or other purposes, unless specifically permitted for limited within the service agreement.\n\n\nCJIS Security Policy 5.11.1\u20132\n\n21.14 If the system is cloud-based, the vendor should agree to FBI and CSA compliance and security audits of CJI.\n\n\nCJIS Security Policy 5.10.3.2\r\nCJIS Security Policy Appendix G.1\n\n21.15 If the system is capable of being run in a virtual environment, it shall meet the virtualization requirements set forth in CJIS Security Policy 5.10.3.2 and best practices set forth in CJIS Security Policy Appendix G.1.\n\n\nCJIS Security Policy Appendix G.5\r\nNIST 800-53, Rev. 5, AC-6(4)\r\n\nNIST 800-53, Rev. 5, SC-39\r\n\n\n\n21.16 The system should provide separate processing domains in order to not only allow for more granular allocation of user privileges, but also to prevent one process from modifying the executing code of another process.\n\n\nNIST 800-53, Rev. 5, IA-2(1\u20132), IA-2(12), and IA-8(1)\n\n21.17 The system should support the use of personal identity verification\u2014a U.S. Federal government-wide credential system\u2014and other forms of hardware-based (i.e., public key infrastructure or PKI) token authentication, while electronically verifying those credentials and any configured token quality requirements.\n\n\nA2LA C223 5.4\n\n21.18 The system should support the identification and tagging of infrequently performed forensic tests or analyses in order to alert the analyst and other stakeholders that additional competency verification or method validation is required before performing the test or analysis.\n\n\nA2LA C223 5.9\n\n21.19 The system should allow case records to be scheduled for periodic administrative and technical review by individuals not connected with the case. The conducted review should indicate details such as who conducted the review, what the results were, and when the review was completed. If non-conforming results were discovered, records of determination and resolution should be appended to the case record.\n\n\nA2LA C223 5.9\n\n21.20 The system should be able to document examiner testimony and allow such testimony to be scheduled for periodic evaluation. The conducted evaluation should indicate details such as who conducted the evaluation, what the results were, and when the review was completed. If non-conforming results were discovered, related records of determination and resolution should be maintained in the system.\n\n\n\n22. Clinical and public health data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nCDC PHIN Messaging System\n\n22.1 The system should be capable of interfacing with the Center for Disease Control and Prevention's PHIN Messaging System.\n\n\nACMG Technical Standards for Clinical Genetics Laboratories G1.5\r\n\n\n22.2 The system should support Human Genome Variation Society (HGVS) nomenclature and terminology for sequence variants.\n\n\nCLSI QMS22 2.1.2.3\n\n22.3 The system should be able to collect sufficient test utilization information to make necessity checks on ordered tests against established benchmarks.\n\n\nONC USCDI v2\n\n22.4 The system should support the United States Core Data for Interoperability (USCDI) v2 standard, which in turn supports data interoperability across multiple clinical settings.\n\n\n\n23. Veterinary data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nNAHLN Information Technology System\r\nVeNom Coding Group\r\nVeterinary Terminology Services Laboratory\n\n23.1 The system should support standardized veterinary clinical terminology such as that found in the Veterinary Extension of SNOMED CT and the Veterinary Nomenclature (VeNom) Codes.\n\n\nICAR 15 Data Exchange\r\nVICH GL53\n\n23.2 The system should be able to exchange data, when necessary, in a fashion that meets International Committee for Animal Recording (ICAR) and Veterinary International Conference on Harmonization (VICH) electronic data exchange guidelines.\n\n\nNAHLN HL7 Messaging Quick User Guide\n\n23.3 The system should support National Animal Health Laboratory Network (NAHLN), and, by extension, Health Level 7 (HL7) result messaging.\n\n\n\n24. Scientific data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASTM E1578-18 E-11-1\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.1 The system shall capture raw instrument data and metadata either as an electronic file or directly via RS-232 or TCP\/IP communication.\n\n\nASTM E1578-18 E-11-2\n\n24.2 The scientific data management system (SDMS) should provide a checksum verification of source and destination data and store that verification data in a secure server with controlled access.\n\n\n\nASTM E1578-18 E-11-1\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.3 The system shall store metadata related to raw instrument data in a database in such a way that the original data generated by instruments for specific samples and tests is easy to retrieve.\n\n\nASTM E1578-18 E-11-4\n\n24.4 The system should be capable of capturing a complete and readable copy of original data and any previous versions of modified data in order to maintain the integrity of that data.\n\n\n\nAAVLD AAVLD Requirements for an AVMDL Sec. 4.10.2.3\r\n\nASTM E1578-18 E-11-5\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.5 The system should secure raw data such that it can't be deleted and provide version control when data is modified by any user or specific software.\n\n\nASTM E1578-18 E-11-6\n\n24.6 The SDMS should provide tools for helping a laboratory achieve the U.S. Food and Drug Administration's defined ALCOA principles.\n\n\nASTM E1578-18 E-11-7\n\n24.7 The SDMS shall provide security and access controls for protecting stored data.\n\n\nASTM E1578-18 E-11-8\n\n24.8 The SDMS shall record an audit trail for each and every record created and modified, using version control.\n\n\n45 CFR Part 164.308\r\nASTM E1578-18 E-11-9\n\n24.9 The SDMS shall provide proper systems for backing up, restoring, and archiving data for long-term use.\n\n\n\n25. Health information technology \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n45 CFR Part 170.315 (a-1\u2013a-4)\n\n25.1 The electronic health record (EHR) module should provide computerized provider order entry (CPOE) functionality for medication orders, laboratory orders, and diagnostic imaging, including making checks for potential drug-drug and drug-allergy interactions.\n\n\n45 CFR Part 170.315 (a-5)\r\n45 CFR Part 170.315 (a-11\u2013a-12)\r\n45 CFR Part 170.315 (a-15)\n\n25.2 The EHR module should allow authorized personnel to record, change, and access patient demographic data, including, but not limited to, race and ethnicity, patient's preferred language, birth sex, current sex, sexual orientation, gender identity, birth date, smoking status, alcohol use, family health history, psychological aspects, social aspects, and behavioral aspects.\n\n\n45 CFR Part 170.315 (a-6\u2013a-8)\r\n45 CFR Part 170.315 (a-10)\r\n45 CFR Part 170.315 (a-14)\n\n25.3 The EHR module should allow authorized personnel to record, change, and access a patient's active problem list, medication list, medication allergy list, preferred drug list, and implantable device list, incorporating, where appropriate, at a minimum the SNOMED CT nomenclature standard.\n\n\n45 CFR Part 170.315 (a-19)\n\n25.4 The EHR module should incorporate configurable, role-based clinical decision support tools capable of allowing authorized personnel to trigger electronic interventions based on liked reference information standardized to Health Level 7 (HL7) Version 3 implementation guides. The reference information should be sourced.\n\n\n45 CFR Part 170.315 (a-13)\n\n25.5 The EHR module should be able to identify education resources specific to a patient's active problem and medication lists. The educational resources should be standardized to Health Level 7 (HL7) Version 3 implementation guides.\n\n\n45 CFR Part 170.315 (b-1\u2013b-2; b-4\u2013b-5)\n\n25.6 The EHR module should allow authorized personnel to create, view, send, and receive transition of care or referral summaries in such a way that the summary is properly formatted, matched to the correct patient, and reconciled according to the standards and protocols outlined in 45 CFR Part 170.315 (b-1), (b-2), (b-4), and (b-5).\n\n\n45 CFR Part 170.315 (b-3)\n\n25.7 The EHR module should allow authorized personnel to conduct electronic prescribing actions such as creating, changing, cancelling, and refilling prescriptions, incorporating at least the RxNorm and NCPDP SCRIPT standards.\n\n\n45 CFR Part 170.315 (b-6)\n\n25.8 The EHR module should allow authorized personnel to configure, create, and store data exports, incorporating at least HL7 Version 3 implementation standards, as well as SNOMED CT and ICD-9 standards.\n\n\n45 CFR Part 170.315 (b-7\u2013b-8)\n\n25.9 The EHR module should allow for the secure creation, sending, and receipt of restricted summary records, incorporating HL7 Version 3 implementation standards.\n\n\n45 CFR Part 170.315 (b-9)\n\n25.10 The EHR module should allow authorized personnel to create, record, change, access, and receive care plan information, incorporating HL7 Version 3 implementation standards.\n\n\n45 CFR Part 170.315 (c)\n\n25.11 The EHR module should provide a means to record, calculate, import, export, filter, and report on clinical quality measures according to the standards outlined in 45 CFR Part 170.315 (c).\n\n\n45 CFR Part 170.315 (d)\n\n25.12 The EHR module shall provide security and access controls for protecting stored data.\n\n\n45 CFR Part 170.315 (d)\n\n25.13 The EHR module shall record an audit trail for each and every record created and modified, using version control.\n\n\n45 CFR Part 170.315 (d-7)\n\n25.14 The EHR module shall either encrypt electronic health information on end-user devices after use of the technology on the device stops or prevent electronic health information from being stored on end-user devices after use of the technology on the device stops.\n\n\n45 CFR Part 170.315 (d-8)\n\n25.15 The EHR module shall ensure that electronically exchanged health information has not been altered during the transfer process, using at least a hashing algorithm secured to SHA-2 or better.\n\n\n45 CFR Part 170.315 (d-11)\n\n25.16 The EHR module should be capable of recording patient disclosures made for treatment, payment, and health care operations.\n\n\n45 CFR Part 170.315 (e-1)\n\n25.17 The EHR module should provide a means for patients and their authorized representatives to view, download, and transmit their personal health information and activity history log from the EHR via an internet-based technology, using the standards outlined in 45 CFR Part 170.315 (e-1).\n\n\n45 CFR Part 170.315 (e-2\u2013e-3)\n\n25.18 The EHR module should provide a means for authorized users to securely send messages to and receive messages from patients, at the same time allowing for the recording, accessing, and linking of information shared by the patient electronically (as well as directly).\n\n\n45 CFR Part 170.315 (f)\n\n25.19 The EHR module should allow vital patient information as it relates to public health to be transmitted to immunization registries, cancer registries, and public health agencies, as well as be accessed after the fact. This includes, but is not limited to, immunization history, surveillance information, laboratory test results, cancer case information, case reports, antimicrobial reporting, and health care survey information.\n\n\n45 CFR Part 170.315 (g-3\u2013g-5)\n\n25.20 The EHR developer should use user-centered and accessibility-centered design processes for creating and testing the EHR's functionality. A quality management system should be used during these processes.\n\n\n45 CFR Part 170.315 (g-6)\n\n25.21 The EHR module's use of clinical document architecture (CDA) should be demonstrated and verified for conformance to the standards identified in 45 CFR Part 170.315 (g-6).\n\n\n45 CFR Part 170.315 (g-7\u2013g-9)\n\n25.22 The EHR module should include an application programming interface (API) that demonstrates the EHR's ability to uniquely identify a patient and corresponding ID\/token in a received records or data category request in order to accurately and securely meet the request for that patient's data. The API should be well documented.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#21._Forensic_case_and_data_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#21._Forensic_case_and_data_management<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 2 May 2022, at 20:54.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2,200 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","5f931466bb9436d113fc17a04bc496cf_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Specialty_Laboratory_Functions rootpage-LII_LIMSpec_Specialty_Laboratory_Functions skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Specialty Laboratory Functions<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover the specialty requirements that come with working in specific industries such as agriculture, pharmaceutical production, and <a href=\"https:\/\/www.limswiki.org\/index.php\/Forensic_science\" title=\"Forensic science\" class=\"wiki-link\" data-key=\"415d36a7b65494677b6d2873d5febec1\">forensic science<\/a>. You'll likely notice that most of the content here isn't covered by <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a>.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"17._Production_management\">17. Production management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.103\" target=\"_blank\">21 CFR Part 211.103<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40 (d)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.4 and 16.20<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.1<\/b> The system should be able to calculate and record theoretical and actual percentage of yield at various phases of processing, manufacturing, and packaging.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.103\" target=\"_blank\">21 CFR Part 211.103<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.2<\/b> The system should provide a means for verification and approval of yield calculations before release for reporting.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.20\" target=\"_blank\">21 CFR Part 820.20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.186\" target=\"_blank\">21 CFR Part 820.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 1.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.3<\/b> The system shall be able to maintain a production facility's quality system in a specific quality system record, in accordance with regulations and guidance such as 21 CFR Part 820.20 and 820.40 (U.S.), E.U. Commission Directive 2003\/94\/EC Article 11 (E.U.), and WHO Technical Report Series, #986, Annex 2, 1.0 (global).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.30\" target=\"_blank\">21 CFR Part 820.30<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (e)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.4<\/b> The system shall be able to create a design control document capable of recording the details surrounding device development, including control number, physical and performance requirements, final output, review, verification, approval, transfer, changes, and complete design history.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.181\" target=\"_blank\">21 CFR Part 820.181<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.184\" target=\"_blank\">21 CFR Part 820.184<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.5<\/b> The system shall be able to create a device master and device history record capable of recording all information described in 21 CFR Part 820.181 and 820.184.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.255\u2013260<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.130\" target=\"_blank\">21 CFR Part 211.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.134\" target=\"_blank\">21 CFR Part 211.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.20\" target=\"_blank\">21 CFR Part 211.20 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.50\" target=\"_blank\">21 CFR Part 211.50 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.202\" target=\"_blank\">21 CFR Part 225.202<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.60\" target=\"_blank\">21 CFR Part 820.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 2 and 4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f\u2013g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.25\u201330<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.6<\/b> The system shall be able to create a batch production record capable of recording complete information regarding batch production and control details such as, but not limited to, a unique batch, lot, or production run number; formulation; specific labeling and packaging; production steps; in-process and laboratory control results; the unique identifier of any equipment used; persons performing and\/or supervising operational steps; and the results of any pre-process or post-production inspections.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.205\u2013210<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.186\" target=\"_blank\">21 CFR Part 211.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.22\u201323<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.7<\/b> The system shall be able to create a master production and control record capable of recording complete information regarding master production and control details.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.150 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.186\" target=\"_blank\">21 CFR Part 211.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 10.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.8<\/b> The system shall require a new or modified master production and control record to be validated, reviewed, and approved before being implemented into production, including allowing that record to be electronically signed by one or more authorized individuals upon approval. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.150 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.22\" target=\"_blank\">21 CFR Part 211.22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.75\" target=\"_blank\">21 CFR Part 820.75<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b, f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.9<\/b> The system shall require a new or modified production and control record to be validated, reviewed, and approved before being implemented in production. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 14.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.10<\/b> The system shall be able to indicate if a sample consists of an in-process manufacturing material and track characteristics of the in-process material such as identity, strength, quality, purity, and approval status.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.11<\/b> The system shall provide a means to track the amount of time between production processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (f-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c) and (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.60\" target=\"_blank\">21 CFR Part 820.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.5.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 14.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.32\u201333<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.12<\/b> The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, certificates of conformity, shelf life or expiration date, storage location, status of examination, and status of approval for use. Any related specifications for those materials should be able to be linked to the received materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.125\" target=\"_blank\">21 CFR Part 211.125 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.7 and 14.22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.35<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.13<\/b> The system shall be capable of recording the changing quantity of inventoried non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, labeling, containers, and packaging materials), including batch and lot numbers and, if applicable, details of disposition after completion of production.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.113<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.125\" target=\"_blank\">21 CFR Part 211.125 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (d\u2013e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.90\" target=\"_blank\">21 CFR Part 820.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.160\" target=\"_blank\">21 CFR Part 820.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 23<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.4, 14.26, and 14.28<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.44\u201345<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.36<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.18\u201319<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.14<\/b> The system shall prevent the internal release for distribution of a completed production batch until an authorized individual has determined the batch's conformance to final specifications and has approved it for release. If a batch is nonconforming, the system shall be able to clearly document it as such (so as to not distribute it) and provide a review and disposition process. Such approval, rejection, review, and disposition activities shall be documented.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\/subpart-C\" target=\"_blank\">21 CFR Part 7 Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.139<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.38<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\/subpart-B\" target=\"_blank\">21 CFR Part 810 Subpart B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 15.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 6.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.32<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.15<\/b> The system shall provide a means to track and record recall activities of manufactured product and devices based on lot, batch, or other identifier, including storage location, necessary disposition details, and reconciliation between distributed and recovered quantities.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.520<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.165\" target=\"_blank\">21 CFR Part 211.165 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.204\" target=\"_blank\">21 CFR Part 211.204<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.71\" target=\"_blank\">21 CFR Part 212.71 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.90\" target=\"_blank\">21 CFR Part 820.90 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.29\u201330<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.16<\/b> The system should allow a completed production batch that has been rejected for use or a returned production batch to be flagged in the system for reprocessing or reworking if it meets relevant criteria.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.145<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 4.11.8.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, I - FSM 19.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 11.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.17<\/b> The system shall support environmental testing protocols for testing the production environment on a scheduled, reportable basis. That support shall include facility and sampling site management functionality that allows for highlighting specific test points in the facility, as well as support for offsite and randomized testing. The system should also allow associated samples, methods, tests, reports, and other documents to clearly indicate they correspond to specific environmental testing protocols.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"18._Statistical_trending_and_control_charts\">18. Statistical trending and control charts<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.7.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-10-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>18.1<\/b> The system should allow authorized users to configure the generation of statistical trending and control charts.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.7.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-10-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>18.2<\/b> The system should allow authorized users to choose specific sample types, tests, and parameters associated with the statistical trending and control charts that can be generated.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"19._Agriculture_and_food_data_management\">19. Agriculture and food data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/orapartners.fda.gov\/cs\/groups\/public\/documents\/document\/b2hh\/bmri\/~edisp\/rpohandbook.pdf\" target=\"_blank\">FDA Office of Regulatory Affairs Data Exchange (ORA DX) Program<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.1<\/b> The system should be able to create or convert an XML or XLS file to ORA DX template specifications, including the use of ORA DX terminology.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.2<\/b> The system shall allow for the assignment of the \"regulatory sample collection\" role and be able to produce a list of individuals in said role, including information such as name, locations assigned, part- or full-time role, and full-time equivalents (if any) used to meet any regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.3<\/b> The system shall allow for the documentation of sampling sites used for normal and regulatory sampling and be able to produce a complete list of such sites on-demand. The documentation should allow for details such as the addition of a unique, never-before-used site code; a region code; demographics; date added to or removed from the system; facility type; sample substrates or commodities available at the site; and relative volume information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.4.12 and 5.4.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.4<\/b> The system shall allow a site that is no longer active for sampling purposes be designated as inactive, yet be allowed to remain on any generated master list. Additionally, such inactive site shall maintain its unique site number in the event the site becomes reinstated as active.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.130\u2013135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507, Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.2, 3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - HACCP 1.X<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 2.2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 2.2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>19.5<\/b> The system shall allow for the development and documentation of hazard analysis and critical control points (HACCP) or other regulatory-driven food safety plan steps, as well as the implementation of those CCPs or steps into configurable laboratory workflow.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.6<\/b> The system shall require a new or modified HACCP or other regulatory-driven food safety plan be validated, reviewed, and approved before being implemented, including requiring that plan to be electronically signed by one or more authorized individuals upon approval.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.92<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>19.7<\/b> The system shall allow for the documentation and management of internal and external audit activities, while allowing samples, methods, tests, results, reports, documents, and more to be clearly associated with that corresponding audit activity.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"20._Environmental_data_management\">20. Environmental data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/geospatial\/epa-metadata-technical-specification\" target=\"_blank\">EPA Metadata Technical Specification<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.1<\/b> The system should support metadata requirements set forth by ISO 19115 and the EPA Metadata Technical Specification for reporting and data publishing purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.2<\/b> The system should support the manual entry or electronic transfer of EPA analytical service requests (ASRs), along with all the required fields of the ASR, including project identifier, project demographics, sample specifics, sample hazards, reporting requirements, and special requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/2015-07\/documents\/sedd52_specification.pdf\" target=\"_blank\">EPA SEDD Specification and Data Element Dictionary v5.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.3<\/b> The system should support the creation and transfer of Staged Electronic Data Deliverable (SEDD) files.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.10\" target=\"_blank\">40 CFR Part 3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/60\" target=\"_blank\">40 CFR Part 60 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/62\" target=\"_blank\">40 CFR Part 62 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/63\" target=\"_blank\">40 CFR Part 63 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>20.4<\/b> The system shall support generating electronic environmental reports (e.g., stationary source emissions tests) in either the EPA's Electronic Reporting Tool (ERT) special spreadsheet format or in an XML file format that complies with EPA-approved XML schema.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/denix.osd.mil\/edqw\/documents\/documents\/gen-data-validation-rev1\/\" target=\"_blank\">DoD General Data Validation Guidelines<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.5<\/b> The system should support electronic data deliverable (EDD) validation by linking the EDD to its quality assurance project plan (QAPP) and the appropriate stage of validation for the EDD's data type.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"21._Forensic_case_and_data_management\">21. Forensic case and data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.4.3<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1459-13 2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 4.1.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 4.1.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 4.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.1<\/b> The system shall be able to assign each piece of collected evidence and each scene a unique identifier using methodologies such as an ID with an incrementing integer (for sequential evidence numbers) or a user-defined naming format for meeting regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.6\u201310<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.2<\/b> The system shall be able to assign each case a unique case identifier that, in addition to an electronic signature, is able to be automatically placed on, at a maximum, each page of the case's associated examination and administration records.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.5.1.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.3<\/b> In addition to a unique case number, the system shall provide a means to add additional information to a case file, including, but not limited to, submitting agency, agency case number, date of case receipt, name of recipient, shipping and receipt details, items associated with the case and their unique designators, notes, test data, related reports, and other documentation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 (throughout)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 (throughout)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.4.3 and 4.5.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.4<\/b> The system should be able to document evidence using an ASTM-compliant evidence log, including, but not limited to, unique identifiers, investigator and custodian names, key dates and times, evidence conditions, and storage location.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.1.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.5<\/b> The system should be able to prevent a piece of evidence from being scheduled for destructive testing until an appropriate authorization for such analysis is acquired and documented.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.6<\/b> The system shall be able to record and maintain chain of custody of evidence that is subdivided in the laboratory in the same way that original evidence items are tracked.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.1.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.7<\/b> The system shall be capable of recording the secondary dissemination to an authorized agency or organization of criminal history record information (CHRI) sourced from U.S. Criminal Justice Information Services (CJIS).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.8<\/b> The system shall be able to record all National Crime Information Center (NCIC) and Interstate Identification Index (III) data transactions, clearly identifying the operator and authorized receiving agency or organization. III records shall also identify requester and recipient using a unique identifier.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(1) <\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.9<\/b> If the system provides remote access to authorized users over authorized devices, the remote access shall be monitored, controlled and documented, particularly for privileged functions. If remote access to privileged functions is allowed, virtual escorting that meets CJIS Security Policy 5.5.6 conditions will be required.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.1.1.1\u20132<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.1.2\u20133<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5(1) <\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.10<\/b> The system shall be capable of putting into place, in their entirety, either the \"basic password standards\" or \"advanced password standards\" described in CJIS Security Policy 5.6.2.1.1.1 and 5.6.2.1.1.2. If PIN and\/or one-time password is also used, the attributes in 5.6.2.1.2 and 5.6.2.1.3 shall also be required.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.11<\/b> If the system supports user-based certificates for authentication, the system shall be configurable enough to require them to be 1. user-specific, not device-specific, 2. used only by one user at any given time, and 3. activated for each use by, e.g., a passphrase or PIN.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2.1\u20132<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(2) <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-13, SC-28, and SC-28(1)<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.12<\/b> The system shall allow \"encryption in transit\" and \"encryption at rest\" of criminal justice information (CJI) that meets or exceeds the requirements of CJIS Security Policy 5.10.1.2.1 and 5.10.1.2.2.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.13<\/b> If the system is cloud-based, the vendor shall ensure that CJI is stored in databases located within the physical boundaries of APB-member countries and within the legal authority of APB-member agencies. Additionally, the vendor shall agree to not use any metadata derived from unencrypted CJI for commercial, advertising, or other purposes, unless specifically permitted for limited within the service agreement.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.11.1\u20132<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.14<\/b> If the system is cloud-based, the vendor should agree to FBI and CSA compliance and security audits of CJI.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.3.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.15<\/b> If the system is capable of being run in a virtual environment, it shall meet the virtualization requirements set forth in CJIS Security Policy 5.10.3.2 and best practices set forth in CJIS Security Policy Appendix G.1.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6(4)<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-39<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.16<\/b> The system should provide separate processing domains in order to not only allow for more granular allocation of user privileges, but also to prevent one process from modifying the executing code of another process.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2(1\u20132), IA-2(12), and IA-8(1)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.17<\/b> The system should support the use of personal identity verification\u2014a U.S. Federal government-wide credential system\u2014and other forms of hardware-based (i.e., public key infrastructure or PKI) token authentication, while electronically verifying those credentials and any configured token quality requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.18<\/b> The system should support the identification and tagging of infrequently performed forensic tests or analyses in order to alert the analyst and other stakeholders that additional competency verification or method validation is required before performing the test or analysis.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.19<\/b> The system should allow case records to be scheduled for periodic administrative and technical review by individuals not connected with the case. The conducted review should indicate details such as who conducted the review, what the results were, and when the review was completed. If non-conforming results were discovered, records of determination and resolution should be appended to the case record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.20<\/b> The system should be able to document examiner testimony and allow such testimony to be scheduled for periodic evaluation. The conducted evaluation should indicate details such as who conducted the evaluation, what the results were, and when the review was completed. If non-conforming results were discovered, related records of determination and resolution should be maintained in the system.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"22._Clinical_and_public_health_data_management\">22. Clinical and public health data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/phin\/tools\/phinms\/index.html\" target=\"_blank\">CDC PHIN Messaging System<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.1<\/b> The system should be capable of interfacing with the Center for Disease Control and Prevention's PHIN Messaging System.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.5<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>22.2<\/b> The system should support Human Genome Variation Society (HGVS) nomenclature and terminology for sequence variants.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.3<\/b> The system should be able to collect sufficient test utilization information to make necessity checks on ordered tests against established benchmarks.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healthit.gov\/isa\/united-states-core-data-interoperability-uscdi\" target=\"_blank\">ONC USCDI v2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.4<\/b> The system should support the United States Core Data for Interoperability (USCDI) v2 standard, which in turn supports data interoperability across multiple clinical settings.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"23._Veterinary_data_management\">23. Veterinary data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphis.usda.gov\/aphis\/ourfocus\/animalhealth\/lab-info-services\/nahln\/ct_nahln_it\" target=\"_blank\">NAHLN Information Technology System<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/venomcoding.org\/\" target=\"_blank\">VeNom Coding Group<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vtsl.vetmed.vt.edu\/\" target=\"_blank\">Veterinary Terminology Services Laboratory<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.1<\/b> The system should support standardized veterinary clinical terminology such as that found in the Veterinary Extension of SNOMED CT and the Veterinary Nomenclature (VeNom) Codes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.icar.org\/Guidelines\/15-Data-Exchange.pdf\" target=\"_blank\">ICAR 15 Data Exchange<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vichsec.org\/en\/guidelines\/general\" target=\"_blank\">VICH GL53<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.2<\/b> The system should be able to exchange data, when necessary, in a fashion that meets International Committee for Animal Recording (ICAR) and Veterinary International Conference on Harmonization (VICH) electronic data exchange guidelines.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphis.usda.gov\/animal_health\/nahln\/downloads\/MessagingQuickGuide.pdf\" target=\"_blank\">NAHLN HL7 Messaging Quick User Guide<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.3<\/b> The system should support National Animal Health Laboratory Network (NAHLN), and, by extension, Health Level 7 (HL7) result messaging.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"24._Scientific_data_management\">24. Scientific data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.1<\/b> The system shall capture raw instrument data and metadata either as an electronic file or directly via RS-232 or TCP\/IP communication.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.2<\/b> The scientific data management system (SDMS) should provide a checksum verification of source and destination data and store that verification data in a secure server with controlled access.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.3<\/b> The system shall store metadata related to raw instrument data in a database in such a way that the original data generated by instruments for specific samples and tests is easy to retrieve.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.4<\/b> The system should be capable of capturing a complete and readable copy of original data and any previous versions of modified data in order to maintain the integrity of that data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD AAVLD Requirements for an AVMDL Sec. 4.10.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.5<\/b> The system should secure raw data such that it can't be deleted and provide version control when data is modified by any user or specific software.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.6<\/b> The SDMS should provide tools for helping a laboratory achieve the U.S. Food and Drug Administration's defined ALCOA principles.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.7<\/b> The SDMS shall provide security and access controls for protecting stored data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.8<\/b> The SDMS shall record an audit trail for each and every record created and modified, using version control.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.9<\/b> The SDMS shall provide proper systems for backing up, restoring, and archiving data for long-term use.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"25._Health_information_technology\">25. Health information technology<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-1\u2013a-4)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.1<\/b> The electronic health record (EHR) module should provide computerized provider order entry (CPOE) functionality for medication orders, laboratory orders, and diagnostic imaging, including making checks for potential drug-drug and drug-allergy interactions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-5)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-11\u2013a-12)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-15)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.2<\/b> The EHR module should allow authorized personnel to record, change, and access patient demographic data, including, but not limited to, race and ethnicity, patient's preferred language, birth sex, current sex, sexual orientation, gender identity, birth date, smoking status, alcohol use, family health history, psychological aspects, social aspects, and behavioral aspects.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-6\u2013a-8)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-10)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-14)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.3<\/b> The EHR module should allow authorized personnel to record, change, and access a patient's active problem list, medication list, medication allergy list, preferred drug list, and implantable device list, incorporating, where appropriate, at a minimum the SNOMED CT nomenclature standard.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-19)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.4<\/b> The EHR module should incorporate configurable, role-based clinical decision support tools capable of allowing authorized personnel to trigger electronic interventions based on liked reference information standardized to Health Level 7 (HL7) Version 3 implementation guides. The reference information should be sourced.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-13)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.5<\/b> The EHR module should be able to identify education resources specific to a patient's active problem and medication lists. The educational resources should be standardized to Health Level 7 (HL7) Version 3 implementation guides.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-1\u2013b-2; b-4\u2013b-5)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.6<\/b> The EHR module should allow authorized personnel to create, view, send, and receive transition of care or referral summaries in such a way that the summary is properly formatted, matched to the correct patient, and reconciled according to the standards and protocols outlined in 45 CFR Part 170.315 (b-1), (b-2), (b-4), and (b-5).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.7<\/b> The EHR module should allow authorized personnel to conduct electronic prescribing actions such as creating, changing, cancelling, and refilling prescriptions, incorporating at least the RxNorm and NCPDP SCRIPT standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-6)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.8<\/b> The EHR module should allow authorized personnel to configure, create, and store data exports, incorporating at least HL7 Version 3 implementation standards, as well as SNOMED CT and ICD-9 standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-7\u2013b-8)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.9<\/b> The EHR module should allow for the secure creation, sending, and receipt of restricted summary records, incorporating HL7 Version 3 implementation standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-9)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.10<\/b> The EHR module should allow authorized personnel to create, record, change, access, and receive care plan information, incorporating HL7 Version 3 implementation standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (c)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.11<\/b> The EHR module should provide a means to record, calculate, import, export, filter, and report on clinical quality measures according to the standards outlined in 45 CFR Part 170.315 (c).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.12<\/b> The EHR module shall provide security and access controls for protecting stored data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.13<\/b> The EHR module shall record an audit trail for each and every record created and modified, using version control.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.14<\/b> The EHR module shall either encrypt electronic health information on end-user devices after use of the technology on the device stops or prevent electronic health information from being stored on end-user devices after use of the technology on the device stops.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-8)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.15<\/b> The EHR module shall ensure that electronically exchanged health information has not been altered during the transfer process, using at least a hashing algorithm secured to SHA-2 or better.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-11)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.16<\/b> The EHR module should be capable of recording patient disclosures made for treatment, payment, and health care operations.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (e-1)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.17<\/b> The EHR module should provide a means for patients and their authorized representatives to view, download, and transmit their personal health information and activity history log from the EHR via an internet-based technology, using the standards outlined in 45 CFR Part 170.315 (e-1).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (e-2\u2013e-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.18<\/b> The EHR module should provide a means for authorized users to securely send messages to and receive messages from patients, at the same time allowing for the recording, accessing, and linking of information shared by the patient electronically (as well as directly).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (f)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.19<\/b> The EHR module should allow vital patient information as it relates to public health to be transmitted to immunization registries, cancer registries, and public health agencies, as well as be accessed after the fact. This includes, but is not limited to, immunization history, surveillance information, laboratory test results, cancer case information, case reports, antimicrobial reporting, and health care survey information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-3\u2013g-5)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.20<\/b> The EHR developer should use user-centered and accessibility-centered design processes for creating and testing the EHR's functionality. A quality management system should be used during these processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-6)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.21<\/b> The EHR module's use of clinical document architecture (CDA) should be demonstrated and verified for conformance to the standards identified in 45 CFR Part 170.315 (g-6).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-7\u2013g-9)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.22<\/b> The EHR module should include an application programming interface (API) that demonstrates the EHR's ability to uniquely identify a patient and corresponding ID\/token in a received records or data category request in order to accurately and securely meet the request for that patient's data. The API should be well documented.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173544\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.091 seconds\nReal time usage: 0.100 seconds\nPreprocessor visited node count: 377\/1000000\nPost\u2010expand include size: 77243\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 20.131 1 -total\n 12.96% 2.609 1 Template:LIMSpec\/Production_management\n 11.73% 2.361 1 Template:LIMSpec\/Environmental_data_management\n 11.17% 2.248 1 Template:LIMSpec\/Veterinary_data_management\n 11.10% 2.234 1 Template:LIMSpec\/Health_information_technology\n 10.88% 2.191 1 Template:LIMSpec\/Scientific_data_management\n 9.85% 1.984 1 Template:LIMSpec\/Public_health_data_management\n 9.80% 1.973 1 Template:LIMSpec\/Forensic_case_and_data_management\n 9.37% 1.887 1 Template:LIMSpec\/Agriculture_and_food_data_management\n 9.11% 1.833 1 Template:LIMSpec\/Statistical_trending_and_control_charts\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11203-0!canonical and timestamp 20221202173544 and revision id 47561. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#21._Forensic_case_and_data_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#21._Forensic_case_and_data_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","5f931466bb9436d113fc17a04bc496cf_images":[],"5f931466bb9436d113fc17a04bc496cf_timestamp":1670002544,"73573980729cbd218a34c5c2e84eb661_type":"article","73573980729cbd218a34c5c2e84eb661_title":"20. Environmental data management","73573980729cbd218a34c5c2e84eb661_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#20._Environmental_data_management","73573980729cbd218a34c5c2e84eb661_plaintext":"\n\nLII:LIMSpec\/Specialty Laboratory FunctionsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover the specialty requirements that come with working in specific industries such as agriculture, pharmaceutical production, and forensic science. You'll likely notice that most of the content here isn't covered by ASTM E1578-18.\n\n17. Production management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 211.103\r\n21 CFR Part 226.40 (d)\r\nWHO Technical Report Series, #986, Annex 2, 16.4 and 16.20\n\n17.1 The system should be able to calculate and record theoretical and actual percentage of yield at various phases of processing, manufacturing, and packaging.\n\n\n21 CFR Part 211.103\n\n17.2 The system should provide a means for verification and approval of yield calculations before release for reporting.\n\n\n\n21 CFR Part 820.20\r\n\n21 CFR Part 820.40\r\n\n21 CFR Part 820.186\r\n\nE.U. Commission Directive 2003\/94\/EC Article 11\r\n\nWHO Technical Report Series, #986, Annex 2, 1.0\n\n\n17.3 The system shall be able to maintain a production facility's quality system in a specific quality system record, in accordance with regulations and guidance such as 21 CFR Part 820.20 and 820.40 (U.S.), E.U. Commission Directive 2003\/94\/EC Article 11 (E.U.), and WHO Technical Report Series, #986, Annex 2, 1.0 (global).\n\n\n21 CFR Part 820.30\r\n21 CFR Part 820.120 (e)\n\n17.4 The system shall be able to create a design control document capable of recording the details surrounding device development, including control number, physical and performance requirements, final output, review, verification, approval, transfer, changes, and complete design history.\n\n\n21 CFR Part 820.181\r\n21 CFR Part 820.184\n\n17.5 The system shall be able to create a device master and device history record capable of recording all information described in 21 CFR Part 820.181 and 820.184.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 111.255\u2013260\r\n\n21 CFR Part 114.100 (b)\r\n\n21 CFR Part 211.105 (b)\r\n\n21 CFR Part 211.130 (e)\r\n\n21 CFR Part 211.134 (c)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.20 (d)\r\n\n21 CFR Part 211.50 (c)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 225.202\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 820.60\r\n\n21 CFR Part 820.70 (a)\r\n\n21 CFR Part 820.80 (c)\r\n\n21 CFR Part 820.120 (d)\r\n\nBRC GSFS, Issue 8, 6.1.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.1.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 8.1\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.1\r\n\nFDA Hazard Analysis Critical Control Point Principle 2 and 4\r\n\nFDA Hazard Analysis Critical Control Point Principle 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11\r\n\nIFS Food 7, Part 2, 4.2.1.1\r\n\nIFS Food 7, Part 2, 4.18.1\r\n\nIFS PACsecure 2, Part 2, 4.2.1.1\r\n\nIFS PACsecure 2, Part 2, 4.18.1\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (3)\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f\u2013g)\r\n\nWHO Technical Report Series, #986, Annex 2, 15.25\u201330\n\n\n17.6 The system shall be able to create a batch production record capable of recording complete information regarding batch production and control details such as, but not limited to, a unique batch, lot, or production run number; formulation; specific labeling and packaging; production steps; in-process and laboratory control results; the unique identifier of any equipment used; persons performing and\/or supervising operational steps; and the results of any pre-process or post-production inspections.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.100 (e)\r\n\n21 CFR Part 111.205\u2013210\r\n\n21 CFR Part 114.100 (b)\r\n\n21 CFR Part 211.186\r\n\n21 CFR Part 212.50 (b)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nBRC GSFS, Issue 8, 3.6.2\r\n\nBRC GSFS, Issue 8, 9.2.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.1.2\r\n\nFDA Hazard Analysis Critical Control Point Principle 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11\r\n\nIFS Food 7, Part 2, 4.2.1.1\r\n\nIFS PACsecure 2, Part 2, 4.2.1.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 15.22\u201323\n\n\n17.7 The system shall be able to create a master production and control record capable of recording complete information regarding master production and control details.\n\n\n\n21 CFR Part 106.100 (e)\r\n\n21 CFR Part 111.123 (a)\r\n\n21 CFR Part 114.100 (c)\r\n\n21 CFR Part 117.150 (d)\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.186\r\n\n21 CFR Part 212.50 (b)\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nBRC GSFS, Issue 8, 9.2.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 10.3\u20134\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.2\r\n\nIFS Food 7, Part 2, 4.2.1.2\r\n\nIFS Food 7, Part 2, 4.3.x\r\n\nIFS Food 7, Part 2, 5.11\r\n\nIFS PACsecure 2, Part 2, 4.2.1.2\r\n\nIFS PACsecure 2, Part 2, 4.3.x\r\n\nIFS PACsecure 2, Part 2, 5.11\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b)\r\n\nWHO Technical Report Series, #986, Annex 2, 4.0\n\n\n17.8 The system shall require a new or modified master production and control record to be validated, reviewed, and approved before being implemented into production, including allowing that record to be electronically signed by one or more authorized individuals upon approval. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n\n\n\n21 CFR Part 111.123 (a)\r\n\n21 CFR Part 114.100 (c)\r\n\n21 CFR Part 117.150 (d)\r\n\n21 CFR Part 211.22\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 820.70 (b)\r\n\n21 CFR Part 820.75\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 10.3\r\n\nIFS Food 7, Part 2, 4.2.1.2\r\n\nIFS Food 7, Part 2, 4.3.x\r\n\nIFS Food 7, Part 2, 5.11\r\n\nIFS PACsecure 2, Part 2, 4.2.1.2\r\n\nIFS PACsecure 2, Part 2, 4.3.x\r\n\nIFS PACsecure 2, Part 2, 5.11\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b, f)\r\n\nWHO Technical Report Series, #986, Annex 2, 4.0\n\n\n17.9 The system shall require a new or modified production and control record to be validated, reviewed, and approved before being implemented in production. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n\n\n\n21 CFR Part 211.110\r\n\n21 CFR Part 212.50\r\n\n21 CFR Part 820.80 (c)\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\r\n\nISO\/TS 22002-1:2009, 14.3\n\n\n17.10 The system shall be able to indicate if a sample consists of an in-process manufacturing material and track characteristics of the in-process material such as identity, strength, quality, purity, and approval status.\n\n\n21 CFR Part 211.111\n\n17.11 The system shall provide a means to track the amount of time between production processes.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.80\r\n\n21 CFR Part 106.100 (f-6)\r\n\n21 CFR Part 117.420\r\n\n21 CFR Part 211.122 (c)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 212.20 (b)\r\n\n21 CFR Part 212.40 (c) and (e)\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.40 (b)\r\n\n21 CFR Part 226.42\r\n\n21 CFR Part 606.120 (b)\r\n\n21 CFR Part 820.60\r\n\n21 CFR Part 820.80 (b)\r\n\n21 CFR Part 820.120 (b)\r\n\nBRC GSFS, Issue 8, 3.6.1\r\n\nBRC GSFS, Issue 8, 3.9.2\r\n\nBRC GSFS, Issue 8, 5.4.4\r\n\nBRC GSFS, Issue 8, 3.5.1\r\n\nBRC GSFS, Issue 8, 9.5.1\u20132\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17\r\n\nIFS Food 7, Part 2, 4.5.2\r\n\nIFS Food 7, Part 2, 4.18.1\r\n\nIFS PACsecure 2, Part 2, 4.5.2\r\n\nIFS PACsecure 2, Part 2, 4.18.1\r\n\nISO\/TS 22002-1:2009, 9.3\r\n\nISO\/TS 22002-1:2009, 14.2\r\n\nISO\/TS 22002-4:2013, 4.6.3\r\n\nISO\/TS 22002-4:2013, 4.11.2\r\n\nISO\/TS 22002-6:2016, 4.6.3\r\n\nISO\/TS 22002-6:2016, 4.11.2\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nWHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21\r\n\nWHO Technical Report Series, #986, Annex 2, 15.32\u201333\n\n\n17.12 The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, certificates of conformity, shelf life or expiration date, storage location, status of examination, and status of approval for use. Any related specifications for those materials should be able to be linked to the received materials.\n\n\n\n21 CFR Part 211.122 (e)\r\n\n21 CFR Part 211.125 (d)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.42\r\n\nBRC GSFS, Issue 8, 3.5.3\r\n\nBRC GSFS, Issue 8, 9.5.3\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17\r\n\nWHO Technical Report Series, #986, Annex 2, 14.7 and 14.22\r\n\nWHO Technical Report Series, #986, Annex 2, 16.35\n\n\n17.13 The system shall be capable of recording the changing quantity of inventoried non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, labeling, containers, and packaging materials), including batch and lot numbers and, if applicable, details of disposition after completion of production.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.70\r\n\n21 CFR Part 111.113\r\n\n21 CFR Part 111.123 (b)\r\n\n21 CFR Part 114.100 (d)\r\n\n21 CFR Part 120.10\r\n\n21 CFR Part 123.6\r\n\n21 CFR Part 211.122 (e)\r\n\n21 CFR Part 211.125 (d)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.42\r\n\n21 CFR Part 606.100 (c)\r\n\n21 CFR Part 820.80 (d\u2013e)\r\n\n21 CFR Part 820.90\r\n\n21 CFR Part 820.160\r\n\nBRC GSFS, Issue 8, 3.8.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.2\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 23\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\nIFS Food 7, Part 2, 5.7.1\r\n\nIFS Food 7, Part 2, 5.10\r\n\nIFS PACsecure 2, Part 2, 5.7.1\r\n\nIFS PACsecure 2, Part 2, 5.10\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.5\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.7\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.5\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.7\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.5\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.7\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (g)\r\n\nWHO Technical Report Series, #986, Annex 2, 14.4, 14.26, and 14.28\r\n\nWHO Technical Report Series, #986, Annex 2, 15.44\u201345\r\n\nWHO Technical Report Series, #986, Annex 2, 16.36\r\n\nWHO Technical Report Series, #986, Annex 2, 17.18\u201319\n\n\n17.14 The system shall prevent the internal release for distribution of a completed production batch until an authorized individual has determined the batch's conformance to final specifications and has approved it for release. If a batch is nonconforming, the system shall be able to clearly document it as such (so as to not distribute it) and provide a review and disposition process. Such approval, rejection, review, and disposition activities shall be documented.\n\n\n\n21 CFR Part 7 Subpart C\r\n\n21 CFR Part 117.139\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 507.38\r\n\n21 CFR Part 810 Subpart B\r\n\nBRC GSFS, Issue 8, 3.11.2\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.5\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\nIFS Food 7, Part 2, 5.9.2\r\n\nIFS PACsecure 2, Part 2, 5.9.2\r\n\nISO\/TS 22002-1:2009, 15.x\r\n\nISO\/TS 22002-4:2013, 4.12\r\n\nISO\/TS 22002-6:2016, 4.12\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.6.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.6.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.3\r\n\nWHO Technical Report Series, #986, Annex 2, 6.0\r\n\nWHO Technical Report Series, #986, Annex 2, 14.32\n\n\n17.15 The system shall provide a means to track and record recall activities of manufactured product and devices based on lot, batch, or other identifier, including storage location, necessary disposition details, and reconciliation between distributed and recovered quantities.\n\n\n\n21 CFR Part 111.520\r\n\n21 CFR Part 211.165 (f)\r\n\n21 CFR Part 211.204\r\n\n21 CFR Part 212.71 (d)\r\n\n21 CFR Part 820.90 (b-2)\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.6\r\n\nWHO Technical Report Series, #986, Annex 2, 14.29\u201330\n\n\n17.16 The system should allow a completed production batch that has been rejected for use or a returned production batch to be flagged in the system for reprocessing or reworking if it meets relevant criteria.\n\n\n\n21 CFR Part 112.145\r\n\nBRC GSFS, Issue 8, 4.11.8.x\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, I - FSM 19.2\r\n\nISO\/TS 22002-1:2009, 11.5\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.8\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.8\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.8\n\n\n17.17 The system shall support environmental testing protocols for testing the production environment on a scheduled, reportable basis. That support shall include facility and sampling site management functionality that allows for highlighting specific test points in the facility, as well as support for offsite and randomized testing. The system should also allow associated samples, methods, tests, reports, and other documents to clearly indicate they correspond to specific environmental testing protocols.\n\n\n\n18. Statistical trending and control charts \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 820.250\r\n\nAIHA-LAP Policies 2018 2A.7.7.1.3\r\n\nASTM E1578-18 E-10-1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7.2.8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.8\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 9\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\n\n\n18.1 The system should allow authorized users to configure the generation of statistical trending and control charts.\n\n\n\n21 CFR Part 820.250\r\n\nAIHA-LAP Policies 2018 2A.7.7.1.3\r\n\nASTM E1578-18 E-10-2\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7.2.8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.8\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 9\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\n\n\n18.2 The system should allow authorized users to choose specific sample types, tests, and parameters associated with the statistical trending and control charts that can be generated.\n\n\n\n19. Agriculture and food data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nFDA Office of Regulatory Affairs Data Exchange (ORA DX) Program\n\n19.1 The system should be able to create or convert an XML or XLS file to ORA DX template specifications, including the use of ORA DX terminology.\n\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\nUSDA Sampling Procedures for PDP 5.3\r\nUSDA Sampling Procedures for PDP 6.2\n\n19.2 The system shall allow for the assignment of the \"regulatory sample collection\" role and be able to produce a list of individuals in said role, including information such as name, locations assigned, part- or full-time role, and full-time equivalents (if any) used to meet any regulatory requirements.\n\n\nUSDA Sampling Procedures for PDP 5.4\n\n19.3 The system shall allow for the documentation of sampling sites used for normal and regulatory sampling and be able to produce a complete list of such sites on-demand. The documentation should allow for details such as the addition of a unique, never-before-used site code; a region code; demographics; date added to or removed from the system; facility type; sample substrates or commodities available at the site; and relative volume information.\n\n\nUSDA Sampling Procedures for PDP 5.4.12 and 5.4.14\n\n19.4 The system shall allow a site that is no longer active for sampling purposes be designated as inactive, yet be allowed to remain on any generated master list. Additionally, such inactive site shall maintain its unique site number in the event the site becomes reinstated as active.\n\n\n\n21 CFR Part 117.130\u2013135\r\n\n21 CFR Part 120 (throughout)\r\n\n21 CFR Part 123.6\r\n\n21 CFR Part 507, Subpart C\r\n\n61 FR 38806, 9 CFR Part 417.x\r\n\nBRC GSFS, Issue 8, 2.x\r\n\nCodex Alimentarius CXC 1-1969, Ch.2, 3.x\r\n\nE.U. Commission Reg. No. 852\/2004 Article 5\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - HACCP 1.X\r\n\nIFS Food 7, Part 2, 2.2.x\r\n\nIFS PACsecure 2, Part 2, 2.2.x\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.3\n\n\n19.5 The system shall allow for the development and documentation of hazard analysis and critical control points (HACCP) or other regulatory-driven food safety plan steps, as well as the implementation of those CCPs or steps into configurable laboratory workflow.\n\n\n61 FR 38806, 9 CFR Part 417.4\n\n19.6 The system shall require a new or modified HACCP or other regulatory-driven food safety plan be validated, reviewed, and approved before being implemented, including requiring that plan to be electronically signed by one or more authorized individuals upon approval.\n\n\n\n21 CFR Part 106.90\r\n\n21 CFR Part 106.92\r\n\n21 CFR Part 106.94\r\n\n21 CFR Part 106.100 (j)\r\n\nBRC GSFS, Issue 8, 3.4.x\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 20\r\n\nIFS Food 7, Part 2, 5.1\r\n\nIFS PACsecure 2, Part 2, 5.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.4\n\n\n19.7 The system shall allow for the documentation and management of internal and external audit activities, while allowing samples, methods, tests, results, reports, documents, and more to be clearly associated with that corresponding audit activity.\n\n\n\n20. Environmental data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nEPA Metadata Technical Specification\n\n20.1 The system should support metadata requirements set forth by ISO 19115 and the EPA Metadata Technical Specification for reporting and data publishing purposes.\n\n\nEPA ERLN Laboratory Requirements 3.3\n\n20.2 The system should support the manual entry or electronic transfer of EPA analytical service requests (ASRs), along with all the required fields of the ASR, including project identifier, project demographics, sample specifics, sample hazards, reporting requirements, and special requirements.\n\n\nEPA SEDD Specification and Data Element Dictionary v5.2\n\n20.3 The system should support the creation and transfer of Staged Electronic Data Deliverable (SEDD) files.\n\n\n\n40 CFR Part 3.10\r\n\n40 CFR Part 60 (throughout)\r\n\n40 CFR Part 62 (throughout)\r\n\n40 CFR Part 63 (throughout)\n\n\n20.4 The system shall support generating electronic environmental reports (e.g., stationary source emissions tests) in either the EPA's Electronic Reporting Tool (ERT) special spreadsheet format or in an XML file format that complies with EPA-approved XML schema.\n\n\nDoD General Data Validation Guidelines\n\n20.5 The system should support electronic data deliverable (EDD) validation by linking the EDD to its quality assurance project plan (QAPP) and the appropriate stage of validation for the EDD's data type.\n\n\n\n21. Forensic case and data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.4.3\nASTM E1188-11 3.2.3\r\n\nASTM E1188-11 3.4.1\r\n\nASTM E1459-13 2.1\r\n\nASTM E1459-13 4.1.1\u20132\r\n\nASTM E1459-13 4.1.4.2\r\n\nASTM E1459-13 4.2.2\u20133\r\n\nASTM E1492-11 4.1.1\r\n\nASTM E1492-11 4.1.5\n\n\n21.1 The system shall be able to assign each piece of collected evidence and each scene a unique identifier using methodologies such as an ID with an incrementing integer (for sequential evidence numbers) or a user-defined naming format for meeting regulatory requirements.\n\n\nA2LA C223 4.13\r\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.6\u201310\r\nASTM E1492-11 4.1.1\r\n\n\n21.2 The system shall be able to assign each case a unique case identifier that, in addition to an electronic signature, is able to be automatically placed on, at a maximum, each page of the case's associated examination and administration records.\n\n\n\nA2LA C223 4.13\r\n\nASTM E1492-11 4.1.1.1\u20132\r\n\nASTM E1492-11 4.1.4\u20135\r\n\nASTM E1492-11 4.2.2\u20133\r\n\nASTM E1492-11 4.5.1.1\n\n\n21.3 In addition to a unique case number, the system shall provide a means to add additional information to a case file, including, but not limited to, submitting agency, agency case number, date of case receipt, name of recipient, shipping and receipt details, items associated with the case and their unique designators, notes, test data, related reports, and other documentation.\n\n\nASTM E1188-11 (throughout)\r\nASTM E1459-13 (throughout)\r\nASTM E1492-11 4.4.3 and 4.5.1\n\n21.4 The system should be able to document evidence using an ASTM-compliant evidence log, including, but not limited to, unique identifiers, investigator and custodian names, key dates and times, evidence conditions, and storage location.\n\n\nASTM E1492-11 4.3.1.1\n\n21.5 The system should be able to prevent a piece of evidence from being scheduled for destructive testing until an appropriate authorization for such analysis is acquired and documented.\n\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1.1\r\nASTM E1492-11 4.1.2\n\n21.6 The system shall be able to record and maintain chain of custody of evidence that is subdivided in the laboratory in the same way that original evidence items are tracked.\n\n\nCJIS Security Policy 5.1.3\n\n21.7 The system shall be capable of recording the secondary dissemination to an authorized agency or organization of criminal history record information (CHRI) sourced from U.S. Criminal Justice Information Services (CJIS).\n\n\nCJIS Security Policy 5.4.7\n\n21.8 The system shall be able to record all National Crime Information Center (NCIC) and Interstate Identification Index (III) data transactions, clearly identifying the operator and authorized receiving agency or organization. III records shall also identify requester and recipient using a unique identifier.\n\n\nCJIS Security Policy 5.5.6\r\nNIST 800-53, Rev. 5, AC-17(1) \r\n\n\n21.9 If the system provides remote access to authorized users over authorized devices, the remote access shall be monitored, controlled and documented, particularly for privileged functions. If remote access to privileged functions is allowed, virtual escorting that meets CJIS Security Policy 5.5.6 conditions will be required.\n\n\nCJIS Security Policy 5.6.2.1.1.1\u20132\r\nCJIS Security Policy 5.6.2.1.2\u20133\r\nNIST 800-53, Rev. 5, IA-5(1) \r\n\n\n21.10 The system shall be capable of putting into place, in their entirety, either the \"basic password standards\" or \"advanced password standards\" described in CJIS Security Policy 5.6.2.1.1.1 and 5.6.2.1.1.2. If PIN and\/or one-time password is also used, the attributes in 5.6.2.1.2 and 5.6.2.1.3 shall also be required.\n\n\nCJIS Security Policy 5.6.2.2\n\n21.11 If the system supports user-based certificates for authentication, the system shall be configurable enough to require them to be 1. user-specific, not device-specific, 2. used only by one user at any given time, and 3. activated for each use by, e.g., a passphrase or PIN.\n\n\nCJIS Security Policy 5.10.1.2.1\u20132\r\n\nCJIS Security Policy Appendix G.6\r\n\nNIST 800-53, Rev. 5, AC-17(2) \r\n\nNIST 800-53, Rev. 5, SC-13, SC-28, and SC-28(1)\r\n\n\n\n21.12 The system shall allow \"encryption in transit\" and \"encryption at rest\" of criminal justice information (CJI) that meets or exceeds the requirements of CJIS Security Policy 5.10.1.2.1 and 5.10.1.2.2.\n\n\nCJIS Security Policy 5.10.1.5\n\n21.13 If the system is cloud-based, the vendor shall ensure that CJI is stored in databases located within the physical boundaries of APB-member countries and within the legal authority of APB-member agencies. Additionally, the vendor shall agree to not use any metadata derived from unencrypted CJI for commercial, advertising, or other purposes, unless specifically permitted for limited within the service agreement.\n\n\nCJIS Security Policy 5.11.1\u20132\n\n21.14 If the system is cloud-based, the vendor should agree to FBI and CSA compliance and security audits of CJI.\n\n\nCJIS Security Policy 5.10.3.2\r\nCJIS Security Policy Appendix G.1\n\n21.15 If the system is capable of being run in a virtual environment, it shall meet the virtualization requirements set forth in CJIS Security Policy 5.10.3.2 and best practices set forth in CJIS Security Policy Appendix G.1.\n\n\nCJIS Security Policy Appendix G.5\r\nNIST 800-53, Rev. 5, AC-6(4)\r\n\nNIST 800-53, Rev. 5, SC-39\r\n\n\n\n21.16 The system should provide separate processing domains in order to not only allow for more granular allocation of user privileges, but also to prevent one process from modifying the executing code of another process.\n\n\nNIST 800-53, Rev. 5, IA-2(1\u20132), IA-2(12), and IA-8(1)\n\n21.17 The system should support the use of personal identity verification\u2014a U.S. Federal government-wide credential system\u2014and other forms of hardware-based (i.e., public key infrastructure or PKI) token authentication, while electronically verifying those credentials and any configured token quality requirements.\n\n\nA2LA C223 5.4\n\n21.18 The system should support the identification and tagging of infrequently performed forensic tests or analyses in order to alert the analyst and other stakeholders that additional competency verification or method validation is required before performing the test or analysis.\n\n\nA2LA C223 5.9\n\n21.19 The system should allow case records to be scheduled for periodic administrative and technical review by individuals not connected with the case. The conducted review should indicate details such as who conducted the review, what the results were, and when the review was completed. If non-conforming results were discovered, records of determination and resolution should be appended to the case record.\n\n\nA2LA C223 5.9\n\n21.20 The system should be able to document examiner testimony and allow such testimony to be scheduled for periodic evaluation. The conducted evaluation should indicate details such as who conducted the evaluation, what the results were, and when the review was completed. If non-conforming results were discovered, related records of determination and resolution should be maintained in the system.\n\n\n\n22. Clinical and public health data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nCDC PHIN Messaging System\n\n22.1 The system should be capable of interfacing with the Center for Disease Control and Prevention's PHIN Messaging System.\n\n\nACMG Technical Standards for Clinical Genetics Laboratories G1.5\r\n\n\n22.2 The system should support Human Genome Variation Society (HGVS) nomenclature and terminology for sequence variants.\n\n\nCLSI QMS22 2.1.2.3\n\n22.3 The system should be able to collect sufficient test utilization information to make necessity checks on ordered tests against established benchmarks.\n\n\nONC USCDI v2\n\n22.4 The system should support the United States Core Data for Interoperability (USCDI) v2 standard, which in turn supports data interoperability across multiple clinical settings.\n\n\n\n23. Veterinary data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nNAHLN Information Technology System\r\nVeNom Coding Group\r\nVeterinary Terminology Services Laboratory\n\n23.1 The system should support standardized veterinary clinical terminology such as that found in the Veterinary Extension of SNOMED CT and the Veterinary Nomenclature (VeNom) Codes.\n\n\nICAR 15 Data Exchange\r\nVICH GL53\n\n23.2 The system should be able to exchange data, when necessary, in a fashion that meets International Committee for Animal Recording (ICAR) and Veterinary International Conference on Harmonization (VICH) electronic data exchange guidelines.\n\n\nNAHLN HL7 Messaging Quick User Guide\n\n23.3 The system should support National Animal Health Laboratory Network (NAHLN), and, by extension, Health Level 7 (HL7) result messaging.\n\n\n\n24. Scientific data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASTM E1578-18 E-11-1\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.1 The system shall capture raw instrument data and metadata either as an electronic file or directly via RS-232 or TCP\/IP communication.\n\n\nASTM E1578-18 E-11-2\n\n24.2 The scientific data management system (SDMS) should provide a checksum verification of source and destination data and store that verification data in a secure server with controlled access.\n\n\n\nASTM E1578-18 E-11-1\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.3 The system shall store metadata related to raw instrument data in a database in such a way that the original data generated by instruments for specific samples and tests is easy to retrieve.\n\n\nASTM E1578-18 E-11-4\n\n24.4 The system should be capable of capturing a complete and readable copy of original data and any previous versions of modified data in order to maintain the integrity of that data.\n\n\n\nAAVLD AAVLD Requirements for an AVMDL Sec. 4.10.2.3\r\n\nASTM E1578-18 E-11-5\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.5 The system should secure raw data such that it can't be deleted and provide version control when data is modified by any user or specific software.\n\n\nASTM E1578-18 E-11-6\n\n24.6 The SDMS should provide tools for helping a laboratory achieve the U.S. Food and Drug Administration's defined ALCOA principles.\n\n\nASTM E1578-18 E-11-7\n\n24.7 The SDMS shall provide security and access controls for protecting stored data.\n\n\nASTM E1578-18 E-11-8\n\n24.8 The SDMS shall record an audit trail for each and every record created and modified, using version control.\n\n\n45 CFR Part 164.308\r\nASTM E1578-18 E-11-9\n\n24.9 The SDMS shall provide proper systems for backing up, restoring, and archiving data for long-term use.\n\n\n\n25. Health information technology \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n45 CFR Part 170.315 (a-1\u2013a-4)\n\n25.1 The electronic health record (EHR) module should provide computerized provider order entry (CPOE) functionality for medication orders, laboratory orders, and diagnostic imaging, including making checks for potential drug-drug and drug-allergy interactions.\n\n\n45 CFR Part 170.315 (a-5)\r\n45 CFR Part 170.315 (a-11\u2013a-12)\r\n45 CFR Part 170.315 (a-15)\n\n25.2 The EHR module should allow authorized personnel to record, change, and access patient demographic data, including, but not limited to, race and ethnicity, patient's preferred language, birth sex, current sex, sexual orientation, gender identity, birth date, smoking status, alcohol use, family health history, psychological aspects, social aspects, and behavioral aspects.\n\n\n45 CFR Part 170.315 (a-6\u2013a-8)\r\n45 CFR Part 170.315 (a-10)\r\n45 CFR Part 170.315 (a-14)\n\n25.3 The EHR module should allow authorized personnel to record, change, and access a patient's active problem list, medication list, medication allergy list, preferred drug list, and implantable device list, incorporating, where appropriate, at a minimum the SNOMED CT nomenclature standard.\n\n\n45 CFR Part 170.315 (a-19)\n\n25.4 The EHR module should incorporate configurable, role-based clinical decision support tools capable of allowing authorized personnel to trigger electronic interventions based on liked reference information standardized to Health Level 7 (HL7) Version 3 implementation guides. The reference information should be sourced.\n\n\n45 CFR Part 170.315 (a-13)\n\n25.5 The EHR module should be able to identify education resources specific to a patient's active problem and medication lists. The educational resources should be standardized to Health Level 7 (HL7) Version 3 implementation guides.\n\n\n45 CFR Part 170.315 (b-1\u2013b-2; b-4\u2013b-5)\n\n25.6 The EHR module should allow authorized personnel to create, view, send, and receive transition of care or referral summaries in such a way that the summary is properly formatted, matched to the correct patient, and reconciled according to the standards and protocols outlined in 45 CFR Part 170.315 (b-1), (b-2), (b-4), and (b-5).\n\n\n45 CFR Part 170.315 (b-3)\n\n25.7 The EHR module should allow authorized personnel to conduct electronic prescribing actions such as creating, changing, cancelling, and refilling prescriptions, incorporating at least the RxNorm and NCPDP SCRIPT standards.\n\n\n45 CFR Part 170.315 (b-6)\n\n25.8 The EHR module should allow authorized personnel to configure, create, and store data exports, incorporating at least HL7 Version 3 implementation standards, as well as SNOMED CT and ICD-9 standards.\n\n\n45 CFR Part 170.315 (b-7\u2013b-8)\n\n25.9 The EHR module should allow for the secure creation, sending, and receipt of restricted summary records, incorporating HL7 Version 3 implementation standards.\n\n\n45 CFR Part 170.315 (b-9)\n\n25.10 The EHR module should allow authorized personnel to create, record, change, access, and receive care plan information, incorporating HL7 Version 3 implementation standards.\n\n\n45 CFR Part 170.315 (c)\n\n25.11 The EHR module should provide a means to record, calculate, import, export, filter, and report on clinical quality measures according to the standards outlined in 45 CFR Part 170.315 (c).\n\n\n45 CFR Part 170.315 (d)\n\n25.12 The EHR module shall provide security and access controls for protecting stored data.\n\n\n45 CFR Part 170.315 (d)\n\n25.13 The EHR module shall record an audit trail for each and every record created and modified, using version control.\n\n\n45 CFR Part 170.315 (d-7)\n\n25.14 The EHR module shall either encrypt electronic health information on end-user devices after use of the technology on the device stops or prevent electronic health information from being stored on end-user devices after use of the technology on the device stops.\n\n\n45 CFR Part 170.315 (d-8)\n\n25.15 The EHR module shall ensure that electronically exchanged health information has not been altered during the transfer process, using at least a hashing algorithm secured to SHA-2 or better.\n\n\n45 CFR Part 170.315 (d-11)\n\n25.16 The EHR module should be capable of recording patient disclosures made for treatment, payment, and health care operations.\n\n\n45 CFR Part 170.315 (e-1)\n\n25.17 The EHR module should provide a means for patients and their authorized representatives to view, download, and transmit their personal health information and activity history log from the EHR via an internet-based technology, using the standards outlined in 45 CFR Part 170.315 (e-1).\n\n\n45 CFR Part 170.315 (e-2\u2013e-3)\n\n25.18 The EHR module should provide a means for authorized users to securely send messages to and receive messages from patients, at the same time allowing for the recording, accessing, and linking of information shared by the patient electronically (as well as directly).\n\n\n45 CFR Part 170.315 (f)\n\n25.19 The EHR module should allow vital patient information as it relates to public health to be transmitted to immunization registries, cancer registries, and public health agencies, as well as be accessed after the fact. This includes, but is not limited to, immunization history, surveillance information, laboratory test results, cancer case information, case reports, antimicrobial reporting, and health care survey information.\n\n\n45 CFR Part 170.315 (g-3\u2013g-5)\n\n25.20 The EHR developer should use user-centered and accessibility-centered design processes for creating and testing the EHR's functionality. A quality management system should be used during these processes.\n\n\n45 CFR Part 170.315 (g-6)\n\n25.21 The EHR module's use of clinical document architecture (CDA) should be demonstrated and verified for conformance to the standards identified in 45 CFR Part 170.315 (g-6).\n\n\n45 CFR Part 170.315 (g-7\u2013g-9)\n\n25.22 The EHR module should include an application programming interface (API) that demonstrates the EHR's ability to uniquely identify a patient and corresponding ID\/token in a received records or data category request in order to accurately and securely meet the request for that patient's data. The API should be well documented.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#20._Environmental_data_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#20._Environmental_data_management<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 2 May 2022, at 20:54.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2,200 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","73573980729cbd218a34c5c2e84eb661_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Specialty_Laboratory_Functions rootpage-LII_LIMSpec_Specialty_Laboratory_Functions skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Specialty Laboratory Functions<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover the specialty requirements that come with working in specific industries such as agriculture, pharmaceutical production, and <a href=\"https:\/\/www.limswiki.org\/index.php\/Forensic_science\" title=\"Forensic science\" class=\"wiki-link\" data-key=\"415d36a7b65494677b6d2873d5febec1\">forensic science<\/a>. You'll likely notice that most of the content here isn't covered by <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a>.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"17._Production_management\">17. Production management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.103\" target=\"_blank\">21 CFR Part 211.103<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40 (d)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.4 and 16.20<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.1<\/b> The system should be able to calculate and record theoretical and actual percentage of yield at various phases of processing, manufacturing, and packaging.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.103\" target=\"_blank\">21 CFR Part 211.103<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.2<\/b> The system should provide a means for verification and approval of yield calculations before release for reporting.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.20\" target=\"_blank\">21 CFR Part 820.20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.186\" target=\"_blank\">21 CFR Part 820.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 1.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.3<\/b> The system shall be able to maintain a production facility's quality system in a specific quality system record, in accordance with regulations and guidance such as 21 CFR Part 820.20 and 820.40 (U.S.), E.U. Commission Directive 2003\/94\/EC Article 11 (E.U.), and WHO Technical Report Series, #986, Annex 2, 1.0 (global).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.30\" target=\"_blank\">21 CFR Part 820.30<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (e)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.4<\/b> The system shall be able to create a design control document capable of recording the details surrounding device development, including control number, physical and performance requirements, final output, review, verification, approval, transfer, changes, and complete design history.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.181\" target=\"_blank\">21 CFR Part 820.181<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.184\" target=\"_blank\">21 CFR Part 820.184<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.5<\/b> The system shall be able to create a device master and device history record capable of recording all information described in 21 CFR Part 820.181 and 820.184.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.255\u2013260<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.130\" target=\"_blank\">21 CFR Part 211.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.134\" target=\"_blank\">21 CFR Part 211.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.20\" target=\"_blank\">21 CFR Part 211.20 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.50\" target=\"_blank\">21 CFR Part 211.50 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.202\" target=\"_blank\">21 CFR Part 225.202<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.60\" target=\"_blank\">21 CFR Part 820.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 2 and 4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f\u2013g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.25\u201330<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.6<\/b> The system shall be able to create a batch production record capable of recording complete information regarding batch production and control details such as, but not limited to, a unique batch, lot, or production run number; formulation; specific labeling and packaging; production steps; in-process and laboratory control results; the unique identifier of any equipment used; persons performing and\/or supervising operational steps; and the results of any pre-process or post-production inspections.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.205\u2013210<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.186\" target=\"_blank\">21 CFR Part 211.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.22\u201323<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.7<\/b> The system shall be able to create a master production and control record capable of recording complete information regarding master production and control details.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.150 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.186\" target=\"_blank\">21 CFR Part 211.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 10.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.8<\/b> The system shall require a new or modified master production and control record to be validated, reviewed, and approved before being implemented into production, including allowing that record to be electronically signed by one or more authorized individuals upon approval. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.150 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.22\" target=\"_blank\">21 CFR Part 211.22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.75\" target=\"_blank\">21 CFR Part 820.75<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b, f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.9<\/b> The system shall require a new or modified production and control record to be validated, reviewed, and approved before being implemented in production. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 14.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.10<\/b> The system shall be able to indicate if a sample consists of an in-process manufacturing material and track characteristics of the in-process material such as identity, strength, quality, purity, and approval status.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.11<\/b> The system shall provide a means to track the amount of time between production processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (f-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c) and (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.60\" target=\"_blank\">21 CFR Part 820.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.5.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 14.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.32\u201333<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.12<\/b> The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, certificates of conformity, shelf life or expiration date, storage location, status of examination, and status of approval for use. Any related specifications for those materials should be able to be linked to the received materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.125\" target=\"_blank\">21 CFR Part 211.125 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.7 and 14.22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.35<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.13<\/b> The system shall be capable of recording the changing quantity of inventoried non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, labeling, containers, and packaging materials), including batch and lot numbers and, if applicable, details of disposition after completion of production.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.113<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.125\" target=\"_blank\">21 CFR Part 211.125 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (d\u2013e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.90\" target=\"_blank\">21 CFR Part 820.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.160\" target=\"_blank\">21 CFR Part 820.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 23<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.4, 14.26, and 14.28<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.44\u201345<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.36<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.18\u201319<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.14<\/b> The system shall prevent the internal release for distribution of a completed production batch until an authorized individual has determined the batch's conformance to final specifications and has approved it for release. If a batch is nonconforming, the system shall be able to clearly document it as such (so as to not distribute it) and provide a review and disposition process. Such approval, rejection, review, and disposition activities shall be documented.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\/subpart-C\" target=\"_blank\">21 CFR Part 7 Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.139<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.38<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\/subpart-B\" target=\"_blank\">21 CFR Part 810 Subpart B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 15.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 6.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.32<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.15<\/b> The system shall provide a means to track and record recall activities of manufactured product and devices based on lot, batch, or other identifier, including storage location, necessary disposition details, and reconciliation between distributed and recovered quantities.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.520<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.165\" target=\"_blank\">21 CFR Part 211.165 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.204\" target=\"_blank\">21 CFR Part 211.204<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.71\" target=\"_blank\">21 CFR Part 212.71 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.90\" target=\"_blank\">21 CFR Part 820.90 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.29\u201330<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.16<\/b> The system should allow a completed production batch that has been rejected for use or a returned production batch to be flagged in the system for reprocessing or reworking if it meets relevant criteria.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.145<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 4.11.8.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, I - FSM 19.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 11.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.17<\/b> The system shall support environmental testing protocols for testing the production environment on a scheduled, reportable basis. That support shall include facility and sampling site management functionality that allows for highlighting specific test points in the facility, as well as support for offsite and randomized testing. The system should also allow associated samples, methods, tests, reports, and other documents to clearly indicate they correspond to specific environmental testing protocols.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"18._Statistical_trending_and_control_charts\">18. Statistical trending and control charts<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.7.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-10-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>18.1<\/b> The system should allow authorized users to configure the generation of statistical trending and control charts.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.7.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-10-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>18.2<\/b> The system should allow authorized users to choose specific sample types, tests, and parameters associated with the statistical trending and control charts that can be generated.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"19._Agriculture_and_food_data_management\">19. Agriculture and food data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/orapartners.fda.gov\/cs\/groups\/public\/documents\/document\/b2hh\/bmri\/~edisp\/rpohandbook.pdf\" target=\"_blank\">FDA Office of Regulatory Affairs Data Exchange (ORA DX) Program<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.1<\/b> The system should be able to create or convert an XML or XLS file to ORA DX template specifications, including the use of ORA DX terminology.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.2<\/b> The system shall allow for the assignment of the \"regulatory sample collection\" role and be able to produce a list of individuals in said role, including information such as name, locations assigned, part- or full-time role, and full-time equivalents (if any) used to meet any regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.3<\/b> The system shall allow for the documentation of sampling sites used for normal and regulatory sampling and be able to produce a complete list of such sites on-demand. The documentation should allow for details such as the addition of a unique, never-before-used site code; a region code; demographics; date added to or removed from the system; facility type; sample substrates or commodities available at the site; and relative volume information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.4.12 and 5.4.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.4<\/b> The system shall allow a site that is no longer active for sampling purposes be designated as inactive, yet be allowed to remain on any generated master list. Additionally, such inactive site shall maintain its unique site number in the event the site becomes reinstated as active.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.130\u2013135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507, Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.2, 3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - HACCP 1.X<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 2.2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 2.2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>19.5<\/b> The system shall allow for the development and documentation of hazard analysis and critical control points (HACCP) or other regulatory-driven food safety plan steps, as well as the implementation of those CCPs or steps into configurable laboratory workflow.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.6<\/b> The system shall require a new or modified HACCP or other regulatory-driven food safety plan be validated, reviewed, and approved before being implemented, including requiring that plan to be electronically signed by one or more authorized individuals upon approval.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.92<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>19.7<\/b> The system shall allow for the documentation and management of internal and external audit activities, while allowing samples, methods, tests, results, reports, documents, and more to be clearly associated with that corresponding audit activity.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"20._Environmental_data_management\">20. Environmental data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/geospatial\/epa-metadata-technical-specification\" target=\"_blank\">EPA Metadata Technical Specification<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.1<\/b> The system should support metadata requirements set forth by ISO 19115 and the EPA Metadata Technical Specification for reporting and data publishing purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.2<\/b> The system should support the manual entry or electronic transfer of EPA analytical service requests (ASRs), along with all the required fields of the ASR, including project identifier, project demographics, sample specifics, sample hazards, reporting requirements, and special requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/2015-07\/documents\/sedd52_specification.pdf\" target=\"_blank\">EPA SEDD Specification and Data Element Dictionary v5.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.3<\/b> The system should support the creation and transfer of Staged Electronic Data Deliverable (SEDD) files.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.10\" target=\"_blank\">40 CFR Part 3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/60\" target=\"_blank\">40 CFR Part 60 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/62\" target=\"_blank\">40 CFR Part 62 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/63\" target=\"_blank\">40 CFR Part 63 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>20.4<\/b> The system shall support generating electronic environmental reports (e.g., stationary source emissions tests) in either the EPA's Electronic Reporting Tool (ERT) special spreadsheet format or in an XML file format that complies with EPA-approved XML schema.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/denix.osd.mil\/edqw\/documents\/documents\/gen-data-validation-rev1\/\" target=\"_blank\">DoD General Data Validation Guidelines<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.5<\/b> The system should support electronic data deliverable (EDD) validation by linking the EDD to its quality assurance project plan (QAPP) and the appropriate stage of validation for the EDD's data type.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"21._Forensic_case_and_data_management\">21. Forensic case and data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.4.3<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1459-13 2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 4.1.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 4.1.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 4.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.1<\/b> The system shall be able to assign each piece of collected evidence and each scene a unique identifier using methodologies such as an ID with an incrementing integer (for sequential evidence numbers) or a user-defined naming format for meeting regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.6\u201310<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.2<\/b> The system shall be able to assign each case a unique case identifier that, in addition to an electronic signature, is able to be automatically placed on, at a maximum, each page of the case's associated examination and administration records.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.5.1.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.3<\/b> In addition to a unique case number, the system shall provide a means to add additional information to a case file, including, but not limited to, submitting agency, agency case number, date of case receipt, name of recipient, shipping and receipt details, items associated with the case and their unique designators, notes, test data, related reports, and other documentation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 (throughout)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 (throughout)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.4.3 and 4.5.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.4<\/b> The system should be able to document evidence using an ASTM-compliant evidence log, including, but not limited to, unique identifiers, investigator and custodian names, key dates and times, evidence conditions, and storage location.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.1.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.5<\/b> The system should be able to prevent a piece of evidence from being scheduled for destructive testing until an appropriate authorization for such analysis is acquired and documented.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.6<\/b> The system shall be able to record and maintain chain of custody of evidence that is subdivided in the laboratory in the same way that original evidence items are tracked.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.1.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.7<\/b> The system shall be capable of recording the secondary dissemination to an authorized agency or organization of criminal history record information (CHRI) sourced from U.S. Criminal Justice Information Services (CJIS).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.8<\/b> The system shall be able to record all National Crime Information Center (NCIC) and Interstate Identification Index (III) data transactions, clearly identifying the operator and authorized receiving agency or organization. III records shall also identify requester and recipient using a unique identifier.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(1) <\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.9<\/b> If the system provides remote access to authorized users over authorized devices, the remote access shall be monitored, controlled and documented, particularly for privileged functions. If remote access to privileged functions is allowed, virtual escorting that meets CJIS Security Policy 5.5.6 conditions will be required.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.1.1.1\u20132<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.1.2\u20133<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5(1) <\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.10<\/b> The system shall be capable of putting into place, in their entirety, either the \"basic password standards\" or \"advanced password standards\" described in CJIS Security Policy 5.6.2.1.1.1 and 5.6.2.1.1.2. If PIN and\/or one-time password is also used, the attributes in 5.6.2.1.2 and 5.6.2.1.3 shall also be required.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.11<\/b> If the system supports user-based certificates for authentication, the system shall be configurable enough to require them to be 1. user-specific, not device-specific, 2. used only by one user at any given time, and 3. activated for each use by, e.g., a passphrase or PIN.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2.1\u20132<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(2) <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-13, SC-28, and SC-28(1)<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.12<\/b> The system shall allow \"encryption in transit\" and \"encryption at rest\" of criminal justice information (CJI) that meets or exceeds the requirements of CJIS Security Policy 5.10.1.2.1 and 5.10.1.2.2.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.13<\/b> If the system is cloud-based, the vendor shall ensure that CJI is stored in databases located within the physical boundaries of APB-member countries and within the legal authority of APB-member agencies. Additionally, the vendor shall agree to not use any metadata derived from unencrypted CJI for commercial, advertising, or other purposes, unless specifically permitted for limited within the service agreement.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.11.1\u20132<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.14<\/b> If the system is cloud-based, the vendor should agree to FBI and CSA compliance and security audits of CJI.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.3.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.15<\/b> If the system is capable of being run in a virtual environment, it shall meet the virtualization requirements set forth in CJIS Security Policy 5.10.3.2 and best practices set forth in CJIS Security Policy Appendix G.1.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6(4)<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-39<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.16<\/b> The system should provide separate processing domains in order to not only allow for more granular allocation of user privileges, but also to prevent one process from modifying the executing code of another process.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2(1\u20132), IA-2(12), and IA-8(1)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.17<\/b> The system should support the use of personal identity verification\u2014a U.S. Federal government-wide credential system\u2014and other forms of hardware-based (i.e., public key infrastructure or PKI) token authentication, while electronically verifying those credentials and any configured token quality requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.18<\/b> The system should support the identification and tagging of infrequently performed forensic tests or analyses in order to alert the analyst and other stakeholders that additional competency verification or method validation is required before performing the test or analysis.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.19<\/b> The system should allow case records to be scheduled for periodic administrative and technical review by individuals not connected with the case. The conducted review should indicate details such as who conducted the review, what the results were, and when the review was completed. If non-conforming results were discovered, records of determination and resolution should be appended to the case record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.20<\/b> The system should be able to document examiner testimony and allow such testimony to be scheduled for periodic evaluation. The conducted evaluation should indicate details such as who conducted the evaluation, what the results were, and when the review was completed. If non-conforming results were discovered, related records of determination and resolution should be maintained in the system.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"22._Clinical_and_public_health_data_management\">22. Clinical and public health data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/phin\/tools\/phinms\/index.html\" target=\"_blank\">CDC PHIN Messaging System<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.1<\/b> The system should be capable of interfacing with the Center for Disease Control and Prevention's PHIN Messaging System.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.5<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>22.2<\/b> The system should support Human Genome Variation Society (HGVS) nomenclature and terminology for sequence variants.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.3<\/b> The system should be able to collect sufficient test utilization information to make necessity checks on ordered tests against established benchmarks.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healthit.gov\/isa\/united-states-core-data-interoperability-uscdi\" target=\"_blank\">ONC USCDI v2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.4<\/b> The system should support the United States Core Data for Interoperability (USCDI) v2 standard, which in turn supports data interoperability across multiple clinical settings.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"23._Veterinary_data_management\">23. Veterinary data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphis.usda.gov\/aphis\/ourfocus\/animalhealth\/lab-info-services\/nahln\/ct_nahln_it\" target=\"_blank\">NAHLN Information Technology System<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/venomcoding.org\/\" target=\"_blank\">VeNom Coding Group<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vtsl.vetmed.vt.edu\/\" target=\"_blank\">Veterinary Terminology Services Laboratory<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.1<\/b> The system should support standardized veterinary clinical terminology such as that found in the Veterinary Extension of SNOMED CT and the Veterinary Nomenclature (VeNom) Codes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.icar.org\/Guidelines\/15-Data-Exchange.pdf\" target=\"_blank\">ICAR 15 Data Exchange<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vichsec.org\/en\/guidelines\/general\" target=\"_blank\">VICH GL53<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.2<\/b> The system should be able to exchange data, when necessary, in a fashion that meets International Committee for Animal Recording (ICAR) and Veterinary International Conference on Harmonization (VICH) electronic data exchange guidelines.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphis.usda.gov\/animal_health\/nahln\/downloads\/MessagingQuickGuide.pdf\" target=\"_blank\">NAHLN HL7 Messaging Quick User Guide<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.3<\/b> The system should support National Animal Health Laboratory Network (NAHLN), and, by extension, Health Level 7 (HL7) result messaging.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"24._Scientific_data_management\">24. Scientific data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.1<\/b> The system shall capture raw instrument data and metadata either as an electronic file or directly via RS-232 or TCP\/IP communication.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.2<\/b> The scientific data management system (SDMS) should provide a checksum verification of source and destination data and store that verification data in a secure server with controlled access.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.3<\/b> The system shall store metadata related to raw instrument data in a database in such a way that the original data generated by instruments for specific samples and tests is easy to retrieve.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.4<\/b> The system should be capable of capturing a complete and readable copy of original data and any previous versions of modified data in order to maintain the integrity of that data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD AAVLD Requirements for an AVMDL Sec. 4.10.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.5<\/b> The system should secure raw data such that it can't be deleted and provide version control when data is modified by any user or specific software.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.6<\/b> The SDMS should provide tools for helping a laboratory achieve the U.S. Food and Drug Administration's defined ALCOA principles.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.7<\/b> The SDMS shall provide security and access controls for protecting stored data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.8<\/b> The SDMS shall record an audit trail for each and every record created and modified, using version control.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.9<\/b> The SDMS shall provide proper systems for backing up, restoring, and archiving data for long-term use.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"25._Health_information_technology\">25. Health information technology<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-1\u2013a-4)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.1<\/b> The electronic health record (EHR) module should provide computerized provider order entry (CPOE) functionality for medication orders, laboratory orders, and diagnostic imaging, including making checks for potential drug-drug and drug-allergy interactions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-5)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-11\u2013a-12)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-15)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.2<\/b> The EHR module should allow authorized personnel to record, change, and access patient demographic data, including, but not limited to, race and ethnicity, patient's preferred language, birth sex, current sex, sexual orientation, gender identity, birth date, smoking status, alcohol use, family health history, psychological aspects, social aspects, and behavioral aspects.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-6\u2013a-8)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-10)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-14)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.3<\/b> The EHR module should allow authorized personnel to record, change, and access a patient's active problem list, medication list, medication allergy list, preferred drug list, and implantable device list, incorporating, where appropriate, at a minimum the SNOMED CT nomenclature standard.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-19)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.4<\/b> The EHR module should incorporate configurable, role-based clinical decision support tools capable of allowing authorized personnel to trigger electronic interventions based on liked reference information standardized to Health Level 7 (HL7) Version 3 implementation guides. The reference information should be sourced.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-13)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.5<\/b> The EHR module should be able to identify education resources specific to a patient's active problem and medication lists. The educational resources should be standardized to Health Level 7 (HL7) Version 3 implementation guides.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-1\u2013b-2; b-4\u2013b-5)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.6<\/b> The EHR module should allow authorized personnel to create, view, send, and receive transition of care or referral summaries in such a way that the summary is properly formatted, matched to the correct patient, and reconciled according to the standards and protocols outlined in 45 CFR Part 170.315 (b-1), (b-2), (b-4), and (b-5).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.7<\/b> The EHR module should allow authorized personnel to conduct electronic prescribing actions such as creating, changing, cancelling, and refilling prescriptions, incorporating at least the RxNorm and NCPDP SCRIPT standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-6)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.8<\/b> The EHR module should allow authorized personnel to configure, create, and store data exports, incorporating at least HL7 Version 3 implementation standards, as well as SNOMED CT and ICD-9 standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-7\u2013b-8)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.9<\/b> The EHR module should allow for the secure creation, sending, and receipt of restricted summary records, incorporating HL7 Version 3 implementation standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-9)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.10<\/b> The EHR module should allow authorized personnel to create, record, change, access, and receive care plan information, incorporating HL7 Version 3 implementation standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (c)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.11<\/b> The EHR module should provide a means to record, calculate, import, export, filter, and report on clinical quality measures according to the standards outlined in 45 CFR Part 170.315 (c).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.12<\/b> The EHR module shall provide security and access controls for protecting stored data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.13<\/b> The EHR module shall record an audit trail for each and every record created and modified, using version control.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.14<\/b> The EHR module shall either encrypt electronic health information on end-user devices after use of the technology on the device stops or prevent electronic health information from being stored on end-user devices after use of the technology on the device stops.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-8)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.15<\/b> The EHR module shall ensure that electronically exchanged health information has not been altered during the transfer process, using at least a hashing algorithm secured to SHA-2 or better.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-11)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.16<\/b> The EHR module should be capable of recording patient disclosures made for treatment, payment, and health care operations.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (e-1)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.17<\/b> The EHR module should provide a means for patients and their authorized representatives to view, download, and transmit their personal health information and activity history log from the EHR via an internet-based technology, using the standards outlined in 45 CFR Part 170.315 (e-1).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (e-2\u2013e-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.18<\/b> The EHR module should provide a means for authorized users to securely send messages to and receive messages from patients, at the same time allowing for the recording, accessing, and linking of information shared by the patient electronically (as well as directly).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (f)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.19<\/b> The EHR module should allow vital patient information as it relates to public health to be transmitted to immunization registries, cancer registries, and public health agencies, as well as be accessed after the fact. This includes, but is not limited to, immunization history, surveillance information, laboratory test results, cancer case information, case reports, antimicrobial reporting, and health care survey information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-3\u2013g-5)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.20<\/b> The EHR developer should use user-centered and accessibility-centered design processes for creating and testing the EHR's functionality. A quality management system should be used during these processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-6)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.21<\/b> The EHR module's use of clinical document architecture (CDA) should be demonstrated and verified for conformance to the standards identified in 45 CFR Part 170.315 (g-6).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-7\u2013g-9)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.22<\/b> The EHR module should include an application programming interface (API) that demonstrates the EHR's ability to uniquely identify a patient and corresponding ID\/token in a received records or data category request in order to accurately and securely meet the request for that patient's data. The API should be well documented.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173544\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.091 seconds\nReal time usage: 0.100 seconds\nPreprocessor visited node count: 377\/1000000\nPost\u2010expand include size: 77243\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 20.131 1 -total\n 12.96% 2.609 1 Template:LIMSpec\/Production_management\n 11.73% 2.361 1 Template:LIMSpec\/Environmental_data_management\n 11.17% 2.248 1 Template:LIMSpec\/Veterinary_data_management\n 11.10% 2.234 1 Template:LIMSpec\/Health_information_technology\n 10.88% 2.191 1 Template:LIMSpec\/Scientific_data_management\n 9.85% 1.984 1 Template:LIMSpec\/Public_health_data_management\n 9.80% 1.973 1 Template:LIMSpec\/Forensic_case_and_data_management\n 9.37% 1.887 1 Template:LIMSpec\/Agriculture_and_food_data_management\n 9.11% 1.833 1 Template:LIMSpec\/Statistical_trending_and_control_charts\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11203-0!canonical and timestamp 20221202173544 and revision id 47561. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#20._Environmental_data_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#20._Environmental_data_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","73573980729cbd218a34c5c2e84eb661_images":[],"73573980729cbd218a34c5c2e84eb661_timestamp":1670002544,"3a680a3c3df3893b3027dc86b948be58_type":"article","3a680a3c3df3893b3027dc86b948be58_title":"19. Agriculture and food data management","3a680a3c3df3893b3027dc86b948be58_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#19._Agriculture_and_food_data_management","3a680a3c3df3893b3027dc86b948be58_plaintext":"\n\nLII:LIMSpec\/Specialty Laboratory FunctionsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover the specialty requirements that come with working in specific industries such as agriculture, pharmaceutical production, and forensic science. You'll likely notice that most of the content here isn't covered by ASTM E1578-18.\n\n17. Production management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 211.103\r\n21 CFR Part 226.40 (d)\r\nWHO Technical Report Series, #986, Annex 2, 16.4 and 16.20\n\n17.1 The system should be able to calculate and record theoretical and actual percentage of yield at various phases of processing, manufacturing, and packaging.\n\n\n21 CFR Part 211.103\n\n17.2 The system should provide a means for verification and approval of yield calculations before release for reporting.\n\n\n\n21 CFR Part 820.20\r\n\n21 CFR Part 820.40\r\n\n21 CFR Part 820.186\r\n\nE.U. Commission Directive 2003\/94\/EC Article 11\r\n\nWHO Technical Report Series, #986, Annex 2, 1.0\n\n\n17.3 The system shall be able to maintain a production facility's quality system in a specific quality system record, in accordance with regulations and guidance such as 21 CFR Part 820.20 and 820.40 (U.S.), E.U. Commission Directive 2003\/94\/EC Article 11 (E.U.), and WHO Technical Report Series, #986, Annex 2, 1.0 (global).\n\n\n21 CFR Part 820.30\r\n21 CFR Part 820.120 (e)\n\n17.4 The system shall be able to create a design control document capable of recording the details surrounding device development, including control number, physical and performance requirements, final output, review, verification, approval, transfer, changes, and complete design history.\n\n\n21 CFR Part 820.181\r\n21 CFR Part 820.184\n\n17.5 The system shall be able to create a device master and device history record capable of recording all information described in 21 CFR Part 820.181 and 820.184.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 111.255\u2013260\r\n\n21 CFR Part 114.100 (b)\r\n\n21 CFR Part 211.105 (b)\r\n\n21 CFR Part 211.130 (e)\r\n\n21 CFR Part 211.134 (c)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.20 (d)\r\n\n21 CFR Part 211.50 (c)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 225.202\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 820.60\r\n\n21 CFR Part 820.70 (a)\r\n\n21 CFR Part 820.80 (c)\r\n\n21 CFR Part 820.120 (d)\r\n\nBRC GSFS, Issue 8, 6.1.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.1.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 8.1\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.1\r\n\nFDA Hazard Analysis Critical Control Point Principle 2 and 4\r\n\nFDA Hazard Analysis Critical Control Point Principle 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11\r\n\nIFS Food 7, Part 2, 4.2.1.1\r\n\nIFS Food 7, Part 2, 4.18.1\r\n\nIFS PACsecure 2, Part 2, 4.2.1.1\r\n\nIFS PACsecure 2, Part 2, 4.18.1\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (3)\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f\u2013g)\r\n\nWHO Technical Report Series, #986, Annex 2, 15.25\u201330\n\n\n17.6 The system shall be able to create a batch production record capable of recording complete information regarding batch production and control details such as, but not limited to, a unique batch, lot, or production run number; formulation; specific labeling and packaging; production steps; in-process and laboratory control results; the unique identifier of any equipment used; persons performing and\/or supervising operational steps; and the results of any pre-process or post-production inspections.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.100 (e)\r\n\n21 CFR Part 111.205\u2013210\r\n\n21 CFR Part 114.100 (b)\r\n\n21 CFR Part 211.186\r\n\n21 CFR Part 212.50 (b)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nBRC GSFS, Issue 8, 3.6.2\r\n\nBRC GSFS, Issue 8, 9.2.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.1.2\r\n\nFDA Hazard Analysis Critical Control Point Principle 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11\r\n\nIFS Food 7, Part 2, 4.2.1.1\r\n\nIFS PACsecure 2, Part 2, 4.2.1.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 15.22\u201323\n\n\n17.7 The system shall be able to create a master production and control record capable of recording complete information regarding master production and control details.\n\n\n\n21 CFR Part 106.100 (e)\r\n\n21 CFR Part 111.123 (a)\r\n\n21 CFR Part 114.100 (c)\r\n\n21 CFR Part 117.150 (d)\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.186\r\n\n21 CFR Part 212.50 (b)\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nBRC GSFS, Issue 8, 9.2.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 10.3\u20134\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.2\r\n\nIFS Food 7, Part 2, 4.2.1.2\r\n\nIFS Food 7, Part 2, 4.3.x\r\n\nIFS Food 7, Part 2, 5.11\r\n\nIFS PACsecure 2, Part 2, 4.2.1.2\r\n\nIFS PACsecure 2, Part 2, 4.3.x\r\n\nIFS PACsecure 2, Part 2, 5.11\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b)\r\n\nWHO Technical Report Series, #986, Annex 2, 4.0\n\n\n17.8 The system shall require a new or modified master production and control record to be validated, reviewed, and approved before being implemented into production, including allowing that record to be electronically signed by one or more authorized individuals upon approval. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n\n\n\n21 CFR Part 111.123 (a)\r\n\n21 CFR Part 114.100 (c)\r\n\n21 CFR Part 117.150 (d)\r\n\n21 CFR Part 211.22\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 820.70 (b)\r\n\n21 CFR Part 820.75\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 10.3\r\n\nIFS Food 7, Part 2, 4.2.1.2\r\n\nIFS Food 7, Part 2, 4.3.x\r\n\nIFS Food 7, Part 2, 5.11\r\n\nIFS PACsecure 2, Part 2, 4.2.1.2\r\n\nIFS PACsecure 2, Part 2, 4.3.x\r\n\nIFS PACsecure 2, Part 2, 5.11\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b, f)\r\n\nWHO Technical Report Series, #986, Annex 2, 4.0\n\n\n17.9 The system shall require a new or modified production and control record to be validated, reviewed, and approved before being implemented in production. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n\n\n\n21 CFR Part 211.110\r\n\n21 CFR Part 212.50\r\n\n21 CFR Part 820.80 (c)\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\r\n\nISO\/TS 22002-1:2009, 14.3\n\n\n17.10 The system shall be able to indicate if a sample consists of an in-process manufacturing material and track characteristics of the in-process material such as identity, strength, quality, purity, and approval status.\n\n\n21 CFR Part 211.111\n\n17.11 The system shall provide a means to track the amount of time between production processes.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.80\r\n\n21 CFR Part 106.100 (f-6)\r\n\n21 CFR Part 117.420\r\n\n21 CFR Part 211.122 (c)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 212.20 (b)\r\n\n21 CFR Part 212.40 (c) and (e)\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.40 (b)\r\n\n21 CFR Part 226.42\r\n\n21 CFR Part 606.120 (b)\r\n\n21 CFR Part 820.60\r\n\n21 CFR Part 820.80 (b)\r\n\n21 CFR Part 820.120 (b)\r\n\nBRC GSFS, Issue 8, 3.6.1\r\n\nBRC GSFS, Issue 8, 3.9.2\r\n\nBRC GSFS, Issue 8, 5.4.4\r\n\nBRC GSFS, Issue 8, 3.5.1\r\n\nBRC GSFS, Issue 8, 9.5.1\u20132\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17\r\n\nIFS Food 7, Part 2, 4.5.2\r\n\nIFS Food 7, Part 2, 4.18.1\r\n\nIFS PACsecure 2, Part 2, 4.5.2\r\n\nIFS PACsecure 2, Part 2, 4.18.1\r\n\nISO\/TS 22002-1:2009, 9.3\r\n\nISO\/TS 22002-1:2009, 14.2\r\n\nISO\/TS 22002-4:2013, 4.6.3\r\n\nISO\/TS 22002-4:2013, 4.11.2\r\n\nISO\/TS 22002-6:2016, 4.6.3\r\n\nISO\/TS 22002-6:2016, 4.11.2\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nWHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21\r\n\nWHO Technical Report Series, #986, Annex 2, 15.32\u201333\n\n\n17.12 The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, certificates of conformity, shelf life or expiration date, storage location, status of examination, and status of approval for use. Any related specifications for those materials should be able to be linked to the received materials.\n\n\n\n21 CFR Part 211.122 (e)\r\n\n21 CFR Part 211.125 (d)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.42\r\n\nBRC GSFS, Issue 8, 3.5.3\r\n\nBRC GSFS, Issue 8, 9.5.3\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17\r\n\nWHO Technical Report Series, #986, Annex 2, 14.7 and 14.22\r\n\nWHO Technical Report Series, #986, Annex 2, 16.35\n\n\n17.13 The system shall be capable of recording the changing quantity of inventoried non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, labeling, containers, and packaging materials), including batch and lot numbers and, if applicable, details of disposition after completion of production.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.70\r\n\n21 CFR Part 111.113\r\n\n21 CFR Part 111.123 (b)\r\n\n21 CFR Part 114.100 (d)\r\n\n21 CFR Part 120.10\r\n\n21 CFR Part 123.6\r\n\n21 CFR Part 211.122 (e)\r\n\n21 CFR Part 211.125 (d)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.42\r\n\n21 CFR Part 606.100 (c)\r\n\n21 CFR Part 820.80 (d\u2013e)\r\n\n21 CFR Part 820.90\r\n\n21 CFR Part 820.160\r\n\nBRC GSFS, Issue 8, 3.8.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.2\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 23\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\nIFS Food 7, Part 2, 5.7.1\r\n\nIFS Food 7, Part 2, 5.10\r\n\nIFS PACsecure 2, Part 2, 5.7.1\r\n\nIFS PACsecure 2, Part 2, 5.10\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.5\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.7\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.5\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.7\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.5\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.7\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (g)\r\n\nWHO Technical Report Series, #986, Annex 2, 14.4, 14.26, and 14.28\r\n\nWHO Technical Report Series, #986, Annex 2, 15.44\u201345\r\n\nWHO Technical Report Series, #986, Annex 2, 16.36\r\n\nWHO Technical Report Series, #986, Annex 2, 17.18\u201319\n\n\n17.14 The system shall prevent the internal release for distribution of a completed production batch until an authorized individual has determined the batch's conformance to final specifications and has approved it for release. If a batch is nonconforming, the system shall be able to clearly document it as such (so as to not distribute it) and provide a review and disposition process. Such approval, rejection, review, and disposition activities shall be documented.\n\n\n\n21 CFR Part 7 Subpart C\r\n\n21 CFR Part 117.139\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 507.38\r\n\n21 CFR Part 810 Subpart B\r\n\nBRC GSFS, Issue 8, 3.11.2\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.5\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\nIFS Food 7, Part 2, 5.9.2\r\n\nIFS PACsecure 2, Part 2, 5.9.2\r\n\nISO\/TS 22002-1:2009, 15.x\r\n\nISO\/TS 22002-4:2013, 4.12\r\n\nISO\/TS 22002-6:2016, 4.12\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.6.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.6.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.3\r\n\nWHO Technical Report Series, #986, Annex 2, 6.0\r\n\nWHO Technical Report Series, #986, Annex 2, 14.32\n\n\n17.15 The system shall provide a means to track and record recall activities of manufactured product and devices based on lot, batch, or other identifier, including storage location, necessary disposition details, and reconciliation between distributed and recovered quantities.\n\n\n\n21 CFR Part 111.520\r\n\n21 CFR Part 211.165 (f)\r\n\n21 CFR Part 211.204\r\n\n21 CFR Part 212.71 (d)\r\n\n21 CFR Part 820.90 (b-2)\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.6\r\n\nWHO Technical Report Series, #986, Annex 2, 14.29\u201330\n\n\n17.16 The system should allow a completed production batch that has been rejected for use or a returned production batch to be flagged in the system for reprocessing or reworking if it meets relevant criteria.\n\n\n\n21 CFR Part 112.145\r\n\nBRC GSFS, Issue 8, 4.11.8.x\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, I - FSM 19.2\r\n\nISO\/TS 22002-1:2009, 11.5\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.8\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.8\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.8\n\n\n17.17 The system shall support environmental testing protocols for testing the production environment on a scheduled, reportable basis. That support shall include facility and sampling site management functionality that allows for highlighting specific test points in the facility, as well as support for offsite and randomized testing. The system should also allow associated samples, methods, tests, reports, and other documents to clearly indicate they correspond to specific environmental testing protocols.\n\n\n\n18. Statistical trending and control charts \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 820.250\r\n\nAIHA-LAP Policies 2018 2A.7.7.1.3\r\n\nASTM E1578-18 E-10-1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7.2.8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.8\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 9\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\n\n\n18.1 The system should allow authorized users to configure the generation of statistical trending and control charts.\n\n\n\n21 CFR Part 820.250\r\n\nAIHA-LAP Policies 2018 2A.7.7.1.3\r\n\nASTM E1578-18 E-10-2\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7.2.8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.8\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 9\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\n\n\n18.2 The system should allow authorized users to choose specific sample types, tests, and parameters associated with the statistical trending and control charts that can be generated.\n\n\n\n19. Agriculture and food data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nFDA Office of Regulatory Affairs Data Exchange (ORA DX) Program\n\n19.1 The system should be able to create or convert an XML or XLS file to ORA DX template specifications, including the use of ORA DX terminology.\n\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\nUSDA Sampling Procedures for PDP 5.3\r\nUSDA Sampling Procedures for PDP 6.2\n\n19.2 The system shall allow for the assignment of the \"regulatory sample collection\" role and be able to produce a list of individuals in said role, including information such as name, locations assigned, part- or full-time role, and full-time equivalents (if any) used to meet any regulatory requirements.\n\n\nUSDA Sampling Procedures for PDP 5.4\n\n19.3 The system shall allow for the documentation of sampling sites used for normal and regulatory sampling and be able to produce a complete list of such sites on-demand. The documentation should allow for details such as the addition of a unique, never-before-used site code; a region code; demographics; date added to or removed from the system; facility type; sample substrates or commodities available at the site; and relative volume information.\n\n\nUSDA Sampling Procedures for PDP 5.4.12 and 5.4.14\n\n19.4 The system shall allow a site that is no longer active for sampling purposes be designated as inactive, yet be allowed to remain on any generated master list. Additionally, such inactive site shall maintain its unique site number in the event the site becomes reinstated as active.\n\n\n\n21 CFR Part 117.130\u2013135\r\n\n21 CFR Part 120 (throughout)\r\n\n21 CFR Part 123.6\r\n\n21 CFR Part 507, Subpart C\r\n\n61 FR 38806, 9 CFR Part 417.x\r\n\nBRC GSFS, Issue 8, 2.x\r\n\nCodex Alimentarius CXC 1-1969, Ch.2, 3.x\r\n\nE.U. Commission Reg. No. 852\/2004 Article 5\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - HACCP 1.X\r\n\nIFS Food 7, Part 2, 2.2.x\r\n\nIFS PACsecure 2, Part 2, 2.2.x\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.3\n\n\n19.5 The system shall allow for the development and documentation of hazard analysis and critical control points (HACCP) or other regulatory-driven food safety plan steps, as well as the implementation of those CCPs or steps into configurable laboratory workflow.\n\n\n61 FR 38806, 9 CFR Part 417.4\n\n19.6 The system shall require a new or modified HACCP or other regulatory-driven food safety plan be validated, reviewed, and approved before being implemented, including requiring that plan to be electronically signed by one or more authorized individuals upon approval.\n\n\n\n21 CFR Part 106.90\r\n\n21 CFR Part 106.92\r\n\n21 CFR Part 106.94\r\n\n21 CFR Part 106.100 (j)\r\n\nBRC GSFS, Issue 8, 3.4.x\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 20\r\n\nIFS Food 7, Part 2, 5.1\r\n\nIFS PACsecure 2, Part 2, 5.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.4\n\n\n19.7 The system shall allow for the documentation and management of internal and external audit activities, while allowing samples, methods, tests, results, reports, documents, and more to be clearly associated with that corresponding audit activity.\n\n\n\n20. Environmental data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nEPA Metadata Technical Specification\n\n20.1 The system should support metadata requirements set forth by ISO 19115 and the EPA Metadata Technical Specification for reporting and data publishing purposes.\n\n\nEPA ERLN Laboratory Requirements 3.3\n\n20.2 The system should support the manual entry or electronic transfer of EPA analytical service requests (ASRs), along with all the required fields of the ASR, including project identifier, project demographics, sample specifics, sample hazards, reporting requirements, and special requirements.\n\n\nEPA SEDD Specification and Data Element Dictionary v5.2\n\n20.3 The system should support the creation and transfer of Staged Electronic Data Deliverable (SEDD) files.\n\n\n\n40 CFR Part 3.10\r\n\n40 CFR Part 60 (throughout)\r\n\n40 CFR Part 62 (throughout)\r\n\n40 CFR Part 63 (throughout)\n\n\n20.4 The system shall support generating electronic environmental reports (e.g., stationary source emissions tests) in either the EPA's Electronic Reporting Tool (ERT) special spreadsheet format or in an XML file format that complies with EPA-approved XML schema.\n\n\nDoD General Data Validation Guidelines\n\n20.5 The system should support electronic data deliverable (EDD) validation by linking the EDD to its quality assurance project plan (QAPP) and the appropriate stage of validation for the EDD's data type.\n\n\n\n21. Forensic case and data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.4.3\nASTM E1188-11 3.2.3\r\n\nASTM E1188-11 3.4.1\r\n\nASTM E1459-13 2.1\r\n\nASTM E1459-13 4.1.1\u20132\r\n\nASTM E1459-13 4.1.4.2\r\n\nASTM E1459-13 4.2.2\u20133\r\n\nASTM E1492-11 4.1.1\r\n\nASTM E1492-11 4.1.5\n\n\n21.1 The system shall be able to assign each piece of collected evidence and each scene a unique identifier using methodologies such as an ID with an incrementing integer (for sequential evidence numbers) or a user-defined naming format for meeting regulatory requirements.\n\n\nA2LA C223 4.13\r\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.6\u201310\r\nASTM E1492-11 4.1.1\r\n\n\n21.2 The system shall be able to assign each case a unique case identifier that, in addition to an electronic signature, is able to be automatically placed on, at a maximum, each page of the case's associated examination and administration records.\n\n\n\nA2LA C223 4.13\r\n\nASTM E1492-11 4.1.1.1\u20132\r\n\nASTM E1492-11 4.1.4\u20135\r\n\nASTM E1492-11 4.2.2\u20133\r\n\nASTM E1492-11 4.5.1.1\n\n\n21.3 In addition to a unique case number, the system shall provide a means to add additional information to a case file, including, but not limited to, submitting agency, agency case number, date of case receipt, name of recipient, shipping and receipt details, items associated with the case and their unique designators, notes, test data, related reports, and other documentation.\n\n\nASTM E1188-11 (throughout)\r\nASTM E1459-13 (throughout)\r\nASTM E1492-11 4.4.3 and 4.5.1\n\n21.4 The system should be able to document evidence using an ASTM-compliant evidence log, including, but not limited to, unique identifiers, investigator and custodian names, key dates and times, evidence conditions, and storage location.\n\n\nASTM E1492-11 4.3.1.1\n\n21.5 The system should be able to prevent a piece of evidence from being scheduled for destructive testing until an appropriate authorization for such analysis is acquired and documented.\n\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1.1\r\nASTM E1492-11 4.1.2\n\n21.6 The system shall be able to record and maintain chain of custody of evidence that is subdivided in the laboratory in the same way that original evidence items are tracked.\n\n\nCJIS Security Policy 5.1.3\n\n21.7 The system shall be capable of recording the secondary dissemination to an authorized agency or organization of criminal history record information (CHRI) sourced from U.S. Criminal Justice Information Services (CJIS).\n\n\nCJIS Security Policy 5.4.7\n\n21.8 The system shall be able to record all National Crime Information Center (NCIC) and Interstate Identification Index (III) data transactions, clearly identifying the operator and authorized receiving agency or organization. III records shall also identify requester and recipient using a unique identifier.\n\n\nCJIS Security Policy 5.5.6\r\nNIST 800-53, Rev. 5, AC-17(1) \r\n\n\n21.9 If the system provides remote access to authorized users over authorized devices, the remote access shall be monitored, controlled and documented, particularly for privileged functions. If remote access to privileged functions is allowed, virtual escorting that meets CJIS Security Policy 5.5.6 conditions will be required.\n\n\nCJIS Security Policy 5.6.2.1.1.1\u20132\r\nCJIS Security Policy 5.6.2.1.2\u20133\r\nNIST 800-53, Rev. 5, IA-5(1) \r\n\n\n21.10 The system shall be capable of putting into place, in their entirety, either the \"basic password standards\" or \"advanced password standards\" described in CJIS Security Policy 5.6.2.1.1.1 and 5.6.2.1.1.2. If PIN and\/or one-time password is also used, the attributes in 5.6.2.1.2 and 5.6.2.1.3 shall also be required.\n\n\nCJIS Security Policy 5.6.2.2\n\n21.11 If the system supports user-based certificates for authentication, the system shall be configurable enough to require them to be 1. user-specific, not device-specific, 2. used only by one user at any given time, and 3. activated for each use by, e.g., a passphrase or PIN.\n\n\nCJIS Security Policy 5.10.1.2.1\u20132\r\n\nCJIS Security Policy Appendix G.6\r\n\nNIST 800-53, Rev. 5, AC-17(2) \r\n\nNIST 800-53, Rev. 5, SC-13, SC-28, and SC-28(1)\r\n\n\n\n21.12 The system shall allow \"encryption in transit\" and \"encryption at rest\" of criminal justice information (CJI) that meets or exceeds the requirements of CJIS Security Policy 5.10.1.2.1 and 5.10.1.2.2.\n\n\nCJIS Security Policy 5.10.1.5\n\n21.13 If the system is cloud-based, the vendor shall ensure that CJI is stored in databases located within the physical boundaries of APB-member countries and within the legal authority of APB-member agencies. Additionally, the vendor shall agree to not use any metadata derived from unencrypted CJI for commercial, advertising, or other purposes, unless specifically permitted for limited within the service agreement.\n\n\nCJIS Security Policy 5.11.1\u20132\n\n21.14 If the system is cloud-based, the vendor should agree to FBI and CSA compliance and security audits of CJI.\n\n\nCJIS Security Policy 5.10.3.2\r\nCJIS Security Policy Appendix G.1\n\n21.15 If the system is capable of being run in a virtual environment, it shall meet the virtualization requirements set forth in CJIS Security Policy 5.10.3.2 and best practices set forth in CJIS Security Policy Appendix G.1.\n\n\nCJIS Security Policy Appendix G.5\r\nNIST 800-53, Rev. 5, AC-6(4)\r\n\nNIST 800-53, Rev. 5, SC-39\r\n\n\n\n21.16 The system should provide separate processing domains in order to not only allow for more granular allocation of user privileges, but also to prevent one process from modifying the executing code of another process.\n\n\nNIST 800-53, Rev. 5, IA-2(1\u20132), IA-2(12), and IA-8(1)\n\n21.17 The system should support the use of personal identity verification\u2014a U.S. Federal government-wide credential system\u2014and other forms of hardware-based (i.e., public key infrastructure or PKI) token authentication, while electronically verifying those credentials and any configured token quality requirements.\n\n\nA2LA C223 5.4\n\n21.18 The system should support the identification and tagging of infrequently performed forensic tests or analyses in order to alert the analyst and other stakeholders that additional competency verification or method validation is required before performing the test or analysis.\n\n\nA2LA C223 5.9\n\n21.19 The system should allow case records to be scheduled for periodic administrative and technical review by individuals not connected with the case. The conducted review should indicate details such as who conducted the review, what the results were, and when the review was completed. If non-conforming results were discovered, records of determination and resolution should be appended to the case record.\n\n\nA2LA C223 5.9\n\n21.20 The system should be able to document examiner testimony and allow such testimony to be scheduled for periodic evaluation. The conducted evaluation should indicate details such as who conducted the evaluation, what the results were, and when the review was completed. If non-conforming results were discovered, related records of determination and resolution should be maintained in the system.\n\n\n\n22. Clinical and public health data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nCDC PHIN Messaging System\n\n22.1 The system should be capable of interfacing with the Center for Disease Control and Prevention's PHIN Messaging System.\n\n\nACMG Technical Standards for Clinical Genetics Laboratories G1.5\r\n\n\n22.2 The system should support Human Genome Variation Society (HGVS) nomenclature and terminology for sequence variants.\n\n\nCLSI QMS22 2.1.2.3\n\n22.3 The system should be able to collect sufficient test utilization information to make necessity checks on ordered tests against established benchmarks.\n\n\nONC USCDI v2\n\n22.4 The system should support the United States Core Data for Interoperability (USCDI) v2 standard, which in turn supports data interoperability across multiple clinical settings.\n\n\n\n23. Veterinary data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nNAHLN Information Technology System\r\nVeNom Coding Group\r\nVeterinary Terminology Services Laboratory\n\n23.1 The system should support standardized veterinary clinical terminology such as that found in the Veterinary Extension of SNOMED CT and the Veterinary Nomenclature (VeNom) Codes.\n\n\nICAR 15 Data Exchange\r\nVICH GL53\n\n23.2 The system should be able to exchange data, when necessary, in a fashion that meets International Committee for Animal Recording (ICAR) and Veterinary International Conference on Harmonization (VICH) electronic data exchange guidelines.\n\n\nNAHLN HL7 Messaging Quick User Guide\n\n23.3 The system should support National Animal Health Laboratory Network (NAHLN), and, by extension, Health Level 7 (HL7) result messaging.\n\n\n\n24. Scientific data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASTM E1578-18 E-11-1\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.1 The system shall capture raw instrument data and metadata either as an electronic file or directly via RS-232 or TCP\/IP communication.\n\n\nASTM E1578-18 E-11-2\n\n24.2 The scientific data management system (SDMS) should provide a checksum verification of source and destination data and store that verification data in a secure server with controlled access.\n\n\n\nASTM E1578-18 E-11-1\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.3 The system shall store metadata related to raw instrument data in a database in such a way that the original data generated by instruments for specific samples and tests is easy to retrieve.\n\n\nASTM E1578-18 E-11-4\n\n24.4 The system should be capable of capturing a complete and readable copy of original data and any previous versions of modified data in order to maintain the integrity of that data.\n\n\n\nAAVLD AAVLD Requirements for an AVMDL Sec. 4.10.2.3\r\n\nASTM E1578-18 E-11-5\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.5 The system should secure raw data such that it can't be deleted and provide version control when data is modified by any user or specific software.\n\n\nASTM E1578-18 E-11-6\n\n24.6 The SDMS should provide tools for helping a laboratory achieve the U.S. Food and Drug Administration's defined ALCOA principles.\n\n\nASTM E1578-18 E-11-7\n\n24.7 The SDMS shall provide security and access controls for protecting stored data.\n\n\nASTM E1578-18 E-11-8\n\n24.8 The SDMS shall record an audit trail for each and every record created and modified, using version control.\n\n\n45 CFR Part 164.308\r\nASTM E1578-18 E-11-9\n\n24.9 The SDMS shall provide proper systems for backing up, restoring, and archiving data for long-term use.\n\n\n\n25. Health information technology \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n45 CFR Part 170.315 (a-1\u2013a-4)\n\n25.1 The electronic health record (EHR) module should provide computerized provider order entry (CPOE) functionality for medication orders, laboratory orders, and diagnostic imaging, including making checks for potential drug-drug and drug-allergy interactions.\n\n\n45 CFR Part 170.315 (a-5)\r\n45 CFR Part 170.315 (a-11\u2013a-12)\r\n45 CFR Part 170.315 (a-15)\n\n25.2 The EHR module should allow authorized personnel to record, change, and access patient demographic data, including, but not limited to, race and ethnicity, patient's preferred language, birth sex, current sex, sexual orientation, gender identity, birth date, smoking status, alcohol use, family health history, psychological aspects, social aspects, and behavioral aspects.\n\n\n45 CFR Part 170.315 (a-6\u2013a-8)\r\n45 CFR Part 170.315 (a-10)\r\n45 CFR Part 170.315 (a-14)\n\n25.3 The EHR module should allow authorized personnel to record, change, and access a patient's active problem list, medication list, medication allergy list, preferred drug list, and implantable device list, incorporating, where appropriate, at a minimum the SNOMED CT nomenclature standard.\n\n\n45 CFR Part 170.315 (a-19)\n\n25.4 The EHR module should incorporate configurable, role-based clinical decision support tools capable of allowing authorized personnel to trigger electronic interventions based on liked reference information standardized to Health Level 7 (HL7) Version 3 implementation guides. The reference information should be sourced.\n\n\n45 CFR Part 170.315 (a-13)\n\n25.5 The EHR module should be able to identify education resources specific to a patient's active problem and medication lists. The educational resources should be standardized to Health Level 7 (HL7) Version 3 implementation guides.\n\n\n45 CFR Part 170.315 (b-1\u2013b-2; b-4\u2013b-5)\n\n25.6 The EHR module should allow authorized personnel to create, view, send, and receive transition of care or referral summaries in such a way that the summary is properly formatted, matched to the correct patient, and reconciled according to the standards and protocols outlined in 45 CFR Part 170.315 (b-1), (b-2), (b-4), and (b-5).\n\n\n45 CFR Part 170.315 (b-3)\n\n25.7 The EHR module should allow authorized personnel to conduct electronic prescribing actions such as creating, changing, cancelling, and refilling prescriptions, incorporating at least the RxNorm and NCPDP SCRIPT standards.\n\n\n45 CFR Part 170.315 (b-6)\n\n25.8 The EHR module should allow authorized personnel to configure, create, and store data exports, incorporating at least HL7 Version 3 implementation standards, as well as SNOMED CT and ICD-9 standards.\n\n\n45 CFR Part 170.315 (b-7\u2013b-8)\n\n25.9 The EHR module should allow for the secure creation, sending, and receipt of restricted summary records, incorporating HL7 Version 3 implementation standards.\n\n\n45 CFR Part 170.315 (b-9)\n\n25.10 The EHR module should allow authorized personnel to create, record, change, access, and receive care plan information, incorporating HL7 Version 3 implementation standards.\n\n\n45 CFR Part 170.315 (c)\n\n25.11 The EHR module should provide a means to record, calculate, import, export, filter, and report on clinical quality measures according to the standards outlined in 45 CFR Part 170.315 (c).\n\n\n45 CFR Part 170.315 (d)\n\n25.12 The EHR module shall provide security and access controls for protecting stored data.\n\n\n45 CFR Part 170.315 (d)\n\n25.13 The EHR module shall record an audit trail for each and every record created and modified, using version control.\n\n\n45 CFR Part 170.315 (d-7)\n\n25.14 The EHR module shall either encrypt electronic health information on end-user devices after use of the technology on the device stops or prevent electronic health information from being stored on end-user devices after use of the technology on the device stops.\n\n\n45 CFR Part 170.315 (d-8)\n\n25.15 The EHR module shall ensure that electronically exchanged health information has not been altered during the transfer process, using at least a hashing algorithm secured to SHA-2 or better.\n\n\n45 CFR Part 170.315 (d-11)\n\n25.16 The EHR module should be capable of recording patient disclosures made for treatment, payment, and health care operations.\n\n\n45 CFR Part 170.315 (e-1)\n\n25.17 The EHR module should provide a means for patients and their authorized representatives to view, download, and transmit their personal health information and activity history log from the EHR via an internet-based technology, using the standards outlined in 45 CFR Part 170.315 (e-1).\n\n\n45 CFR Part 170.315 (e-2\u2013e-3)\n\n25.18 The EHR module should provide a means for authorized users to securely send messages to and receive messages from patients, at the same time allowing for the recording, accessing, and linking of information shared by the patient electronically (as well as directly).\n\n\n45 CFR Part 170.315 (f)\n\n25.19 The EHR module should allow vital patient information as it relates to public health to be transmitted to immunization registries, cancer registries, and public health agencies, as well as be accessed after the fact. This includes, but is not limited to, immunization history, surveillance information, laboratory test results, cancer case information, case reports, antimicrobial reporting, and health care survey information.\n\n\n45 CFR Part 170.315 (g-3\u2013g-5)\n\n25.20 The EHR developer should use user-centered and accessibility-centered design processes for creating and testing the EHR's functionality. A quality management system should be used during these processes.\n\n\n45 CFR Part 170.315 (g-6)\n\n25.21 The EHR module's use of clinical document architecture (CDA) should be demonstrated and verified for conformance to the standards identified in 45 CFR Part 170.315 (g-6).\n\n\n45 CFR Part 170.315 (g-7\u2013g-9)\n\n25.22 The EHR module should include an application programming interface (API) that demonstrates the EHR's ability to uniquely identify a patient and corresponding ID\/token in a received records or data category request in order to accurately and securely meet the request for that patient's data. The API should be well documented.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#19._Agriculture_and_food_data_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#19._Agriculture_and_food_data_management<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 2 May 2022, at 20:54.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2,200 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","3a680a3c3df3893b3027dc86b948be58_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Specialty_Laboratory_Functions rootpage-LII_LIMSpec_Specialty_Laboratory_Functions skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Specialty Laboratory Functions<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover the specialty requirements that come with working in specific industries such as agriculture, pharmaceutical production, and <a href=\"https:\/\/www.limswiki.org\/index.php\/Forensic_science\" title=\"Forensic science\" class=\"wiki-link\" data-key=\"415d36a7b65494677b6d2873d5febec1\">forensic science<\/a>. You'll likely notice that most of the content here isn't covered by <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a>.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"17._Production_management\">17. Production management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.103\" target=\"_blank\">21 CFR Part 211.103<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40 (d)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.4 and 16.20<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.1<\/b> The system should be able to calculate and record theoretical and actual percentage of yield at various phases of processing, manufacturing, and packaging.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.103\" target=\"_blank\">21 CFR Part 211.103<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.2<\/b> The system should provide a means for verification and approval of yield calculations before release for reporting.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.20\" target=\"_blank\">21 CFR Part 820.20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.186\" target=\"_blank\">21 CFR Part 820.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 1.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.3<\/b> The system shall be able to maintain a production facility's quality system in a specific quality system record, in accordance with regulations and guidance such as 21 CFR Part 820.20 and 820.40 (U.S.), E.U. Commission Directive 2003\/94\/EC Article 11 (E.U.), and WHO Technical Report Series, #986, Annex 2, 1.0 (global).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.30\" target=\"_blank\">21 CFR Part 820.30<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (e)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.4<\/b> The system shall be able to create a design control document capable of recording the details surrounding device development, including control number, physical and performance requirements, final output, review, verification, approval, transfer, changes, and complete design history.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.181\" target=\"_blank\">21 CFR Part 820.181<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.184\" target=\"_blank\">21 CFR Part 820.184<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.5<\/b> The system shall be able to create a device master and device history record capable of recording all information described in 21 CFR Part 820.181 and 820.184.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.255\u2013260<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.130\" target=\"_blank\">21 CFR Part 211.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.134\" target=\"_blank\">21 CFR Part 211.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.20\" target=\"_blank\">21 CFR Part 211.20 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.50\" target=\"_blank\">21 CFR Part 211.50 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.202\" target=\"_blank\">21 CFR Part 225.202<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.60\" target=\"_blank\">21 CFR Part 820.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 2 and 4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f\u2013g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.25\u201330<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.6<\/b> The system shall be able to create a batch production record capable of recording complete information regarding batch production and control details such as, but not limited to, a unique batch, lot, or production run number; formulation; specific labeling and packaging; production steps; in-process and laboratory control results; the unique identifier of any equipment used; persons performing and\/or supervising operational steps; and the results of any pre-process or post-production inspections.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.205\u2013210<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.186\" target=\"_blank\">21 CFR Part 211.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.22\u201323<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.7<\/b> The system shall be able to create a master production and control record capable of recording complete information regarding master production and control details.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.150 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.186\" target=\"_blank\">21 CFR Part 211.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 10.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.8<\/b> The system shall require a new or modified master production and control record to be validated, reviewed, and approved before being implemented into production, including allowing that record to be electronically signed by one or more authorized individuals upon approval. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.150 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.22\" target=\"_blank\">21 CFR Part 211.22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.75\" target=\"_blank\">21 CFR Part 820.75<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b, f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.9<\/b> The system shall require a new or modified production and control record to be validated, reviewed, and approved before being implemented in production. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 14.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.10<\/b> The system shall be able to indicate if a sample consists of an in-process manufacturing material and track characteristics of the in-process material such as identity, strength, quality, purity, and approval status.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.11<\/b> The system shall provide a means to track the amount of time between production processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (f-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c) and (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.60\" target=\"_blank\">21 CFR Part 820.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.5.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 14.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.32\u201333<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.12<\/b> The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, certificates of conformity, shelf life or expiration date, storage location, status of examination, and status of approval for use. Any related specifications for those materials should be able to be linked to the received materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.125\" target=\"_blank\">21 CFR Part 211.125 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.7 and 14.22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.35<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.13<\/b> The system shall be capable of recording the changing quantity of inventoried non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, labeling, containers, and packaging materials), including batch and lot numbers and, if applicable, details of disposition after completion of production.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.113<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.125\" target=\"_blank\">21 CFR Part 211.125 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (d\u2013e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.90\" target=\"_blank\">21 CFR Part 820.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.160\" target=\"_blank\">21 CFR Part 820.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 23<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.4, 14.26, and 14.28<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.44\u201345<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.36<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.18\u201319<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.14<\/b> The system shall prevent the internal release for distribution of a completed production batch until an authorized individual has determined the batch's conformance to final specifications and has approved it for release. If a batch is nonconforming, the system shall be able to clearly document it as such (so as to not distribute it) and provide a review and disposition process. Such approval, rejection, review, and disposition activities shall be documented.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\/subpart-C\" target=\"_blank\">21 CFR Part 7 Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.139<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.38<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\/subpart-B\" target=\"_blank\">21 CFR Part 810 Subpart B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 15.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 6.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.32<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.15<\/b> The system shall provide a means to track and record recall activities of manufactured product and devices based on lot, batch, or other identifier, including storage location, necessary disposition details, and reconciliation between distributed and recovered quantities.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.520<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.165\" target=\"_blank\">21 CFR Part 211.165 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.204\" target=\"_blank\">21 CFR Part 211.204<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.71\" target=\"_blank\">21 CFR Part 212.71 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.90\" target=\"_blank\">21 CFR Part 820.90 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.29\u201330<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.16<\/b> The system should allow a completed production batch that has been rejected for use or a returned production batch to be flagged in the system for reprocessing or reworking if it meets relevant criteria.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.145<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 4.11.8.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, I - FSM 19.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 11.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.17<\/b> The system shall support environmental testing protocols for testing the production environment on a scheduled, reportable basis. That support shall include facility and sampling site management functionality that allows for highlighting specific test points in the facility, as well as support for offsite and randomized testing. The system should also allow associated samples, methods, tests, reports, and other documents to clearly indicate they correspond to specific environmental testing protocols.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"18._Statistical_trending_and_control_charts\">18. Statistical trending and control charts<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.7.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-10-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>18.1<\/b> The system should allow authorized users to configure the generation of statistical trending and control charts.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.7.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-10-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>18.2<\/b> The system should allow authorized users to choose specific sample types, tests, and parameters associated with the statistical trending and control charts that can be generated.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"19._Agriculture_and_food_data_management\">19. Agriculture and food data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/orapartners.fda.gov\/cs\/groups\/public\/documents\/document\/b2hh\/bmri\/~edisp\/rpohandbook.pdf\" target=\"_blank\">FDA Office of Regulatory Affairs Data Exchange (ORA DX) Program<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.1<\/b> The system should be able to create or convert an XML or XLS file to ORA DX template specifications, including the use of ORA DX terminology.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.2<\/b> The system shall allow for the assignment of the \"regulatory sample collection\" role and be able to produce a list of individuals in said role, including information such as name, locations assigned, part- or full-time role, and full-time equivalents (if any) used to meet any regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.3<\/b> The system shall allow for the documentation of sampling sites used for normal and regulatory sampling and be able to produce a complete list of such sites on-demand. The documentation should allow for details such as the addition of a unique, never-before-used site code; a region code; demographics; date added to or removed from the system; facility type; sample substrates or commodities available at the site; and relative volume information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.4.12 and 5.4.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.4<\/b> The system shall allow a site that is no longer active for sampling purposes be designated as inactive, yet be allowed to remain on any generated master list. Additionally, such inactive site shall maintain its unique site number in the event the site becomes reinstated as active.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.130\u2013135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507, Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.2, 3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - HACCP 1.X<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 2.2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 2.2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>19.5<\/b> The system shall allow for the development and documentation of hazard analysis and critical control points (HACCP) or other regulatory-driven food safety plan steps, as well as the implementation of those CCPs or steps into configurable laboratory workflow.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.6<\/b> The system shall require a new or modified HACCP or other regulatory-driven food safety plan be validated, reviewed, and approved before being implemented, including requiring that plan to be electronically signed by one or more authorized individuals upon approval.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.92<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>19.7<\/b> The system shall allow for the documentation and management of internal and external audit activities, while allowing samples, methods, tests, results, reports, documents, and more to be clearly associated with that corresponding audit activity.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"20._Environmental_data_management\">20. Environmental data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/geospatial\/epa-metadata-technical-specification\" target=\"_blank\">EPA Metadata Technical Specification<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.1<\/b> The system should support metadata requirements set forth by ISO 19115 and the EPA Metadata Technical Specification for reporting and data publishing purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.2<\/b> The system should support the manual entry or electronic transfer of EPA analytical service requests (ASRs), along with all the required fields of the ASR, including project identifier, project demographics, sample specifics, sample hazards, reporting requirements, and special requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/2015-07\/documents\/sedd52_specification.pdf\" target=\"_blank\">EPA SEDD Specification and Data Element Dictionary v5.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.3<\/b> The system should support the creation and transfer of Staged Electronic Data Deliverable (SEDD) files.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.10\" target=\"_blank\">40 CFR Part 3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/60\" target=\"_blank\">40 CFR Part 60 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/62\" target=\"_blank\">40 CFR Part 62 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/63\" target=\"_blank\">40 CFR Part 63 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>20.4<\/b> The system shall support generating electronic environmental reports (e.g., stationary source emissions tests) in either the EPA's Electronic Reporting Tool (ERT) special spreadsheet format or in an XML file format that complies with EPA-approved XML schema.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/denix.osd.mil\/edqw\/documents\/documents\/gen-data-validation-rev1\/\" target=\"_blank\">DoD General Data Validation Guidelines<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.5<\/b> The system should support electronic data deliverable (EDD) validation by linking the EDD to its quality assurance project plan (QAPP) and the appropriate stage of validation for the EDD's data type.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"21._Forensic_case_and_data_management\">21. Forensic case and data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.4.3<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1459-13 2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 4.1.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 4.1.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 4.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.1<\/b> The system shall be able to assign each piece of collected evidence and each scene a unique identifier using methodologies such as an ID with an incrementing integer (for sequential evidence numbers) or a user-defined naming format for meeting regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.6\u201310<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.2<\/b> The system shall be able to assign each case a unique case identifier that, in addition to an electronic signature, is able to be automatically placed on, at a maximum, each page of the case's associated examination and administration records.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.5.1.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.3<\/b> In addition to a unique case number, the system shall provide a means to add additional information to a case file, including, but not limited to, submitting agency, agency case number, date of case receipt, name of recipient, shipping and receipt details, items associated with the case and their unique designators, notes, test data, related reports, and other documentation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 (throughout)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 (throughout)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.4.3 and 4.5.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.4<\/b> The system should be able to document evidence using an ASTM-compliant evidence log, including, but not limited to, unique identifiers, investigator and custodian names, key dates and times, evidence conditions, and storage location.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.1.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.5<\/b> The system should be able to prevent a piece of evidence from being scheduled for destructive testing until an appropriate authorization for such analysis is acquired and documented.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.6<\/b> The system shall be able to record and maintain chain of custody of evidence that is subdivided in the laboratory in the same way that original evidence items are tracked.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.1.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.7<\/b> The system shall be capable of recording the secondary dissemination to an authorized agency or organization of criminal history record information (CHRI) sourced from U.S. Criminal Justice Information Services (CJIS).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.8<\/b> The system shall be able to record all National Crime Information Center (NCIC) and Interstate Identification Index (III) data transactions, clearly identifying the operator and authorized receiving agency or organization. III records shall also identify requester and recipient using a unique identifier.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(1) <\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.9<\/b> If the system provides remote access to authorized users over authorized devices, the remote access shall be monitored, controlled and documented, particularly for privileged functions. If remote access to privileged functions is allowed, virtual escorting that meets CJIS Security Policy 5.5.6 conditions will be required.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.1.1.1\u20132<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.1.2\u20133<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5(1) <\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.10<\/b> The system shall be capable of putting into place, in their entirety, either the \"basic password standards\" or \"advanced password standards\" described in CJIS Security Policy 5.6.2.1.1.1 and 5.6.2.1.1.2. If PIN and\/or one-time password is also used, the attributes in 5.6.2.1.2 and 5.6.2.1.3 shall also be required.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.11<\/b> If the system supports user-based certificates for authentication, the system shall be configurable enough to require them to be 1. user-specific, not device-specific, 2. used only by one user at any given time, and 3. activated for each use by, e.g., a passphrase or PIN.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2.1\u20132<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(2) <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-13, SC-28, and SC-28(1)<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.12<\/b> The system shall allow \"encryption in transit\" and \"encryption at rest\" of criminal justice information (CJI) that meets or exceeds the requirements of CJIS Security Policy 5.10.1.2.1 and 5.10.1.2.2.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.13<\/b> If the system is cloud-based, the vendor shall ensure that CJI is stored in databases located within the physical boundaries of APB-member countries and within the legal authority of APB-member agencies. Additionally, the vendor shall agree to not use any metadata derived from unencrypted CJI for commercial, advertising, or other purposes, unless specifically permitted for limited within the service agreement.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.11.1\u20132<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.14<\/b> If the system is cloud-based, the vendor should agree to FBI and CSA compliance and security audits of CJI.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.3.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.15<\/b> If the system is capable of being run in a virtual environment, it shall meet the virtualization requirements set forth in CJIS Security Policy 5.10.3.2 and best practices set forth in CJIS Security Policy Appendix G.1.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6(4)<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-39<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.16<\/b> The system should provide separate processing domains in order to not only allow for more granular allocation of user privileges, but also to prevent one process from modifying the executing code of another process.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2(1\u20132), IA-2(12), and IA-8(1)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.17<\/b> The system should support the use of personal identity verification\u2014a U.S. Federal government-wide credential system\u2014and other forms of hardware-based (i.e., public key infrastructure or PKI) token authentication, while electronically verifying those credentials and any configured token quality requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.18<\/b> The system should support the identification and tagging of infrequently performed forensic tests or analyses in order to alert the analyst and other stakeholders that additional competency verification or method validation is required before performing the test or analysis.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.19<\/b> The system should allow case records to be scheduled for periodic administrative and technical review by individuals not connected with the case. The conducted review should indicate details such as who conducted the review, what the results were, and when the review was completed. If non-conforming results were discovered, records of determination and resolution should be appended to the case record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.20<\/b> The system should be able to document examiner testimony and allow such testimony to be scheduled for periodic evaluation. The conducted evaluation should indicate details such as who conducted the evaluation, what the results were, and when the review was completed. If non-conforming results were discovered, related records of determination and resolution should be maintained in the system.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"22._Clinical_and_public_health_data_management\">22. Clinical and public health data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/phin\/tools\/phinms\/index.html\" target=\"_blank\">CDC PHIN Messaging System<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.1<\/b> The system should be capable of interfacing with the Center for Disease Control and Prevention's PHIN Messaging System.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.5<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>22.2<\/b> The system should support Human Genome Variation Society (HGVS) nomenclature and terminology for sequence variants.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.3<\/b> The system should be able to collect sufficient test utilization information to make necessity checks on ordered tests against established benchmarks.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healthit.gov\/isa\/united-states-core-data-interoperability-uscdi\" target=\"_blank\">ONC USCDI v2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.4<\/b> The system should support the United States Core Data for Interoperability (USCDI) v2 standard, which in turn supports data interoperability across multiple clinical settings.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"23._Veterinary_data_management\">23. Veterinary data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphis.usda.gov\/aphis\/ourfocus\/animalhealth\/lab-info-services\/nahln\/ct_nahln_it\" target=\"_blank\">NAHLN Information Technology System<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/venomcoding.org\/\" target=\"_blank\">VeNom Coding Group<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vtsl.vetmed.vt.edu\/\" target=\"_blank\">Veterinary Terminology Services Laboratory<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.1<\/b> The system should support standardized veterinary clinical terminology such as that found in the Veterinary Extension of SNOMED CT and the Veterinary Nomenclature (VeNom) Codes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.icar.org\/Guidelines\/15-Data-Exchange.pdf\" target=\"_blank\">ICAR 15 Data Exchange<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vichsec.org\/en\/guidelines\/general\" target=\"_blank\">VICH GL53<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.2<\/b> The system should be able to exchange data, when necessary, in a fashion that meets International Committee for Animal Recording (ICAR) and Veterinary International Conference on Harmonization (VICH) electronic data exchange guidelines.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphis.usda.gov\/animal_health\/nahln\/downloads\/MessagingQuickGuide.pdf\" target=\"_blank\">NAHLN HL7 Messaging Quick User Guide<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.3<\/b> The system should support National Animal Health Laboratory Network (NAHLN), and, by extension, Health Level 7 (HL7) result messaging.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"24._Scientific_data_management\">24. Scientific data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.1<\/b> The system shall capture raw instrument data and metadata either as an electronic file or directly via RS-232 or TCP\/IP communication.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.2<\/b> The scientific data management system (SDMS) should provide a checksum verification of source and destination data and store that verification data in a secure server with controlled access.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.3<\/b> The system shall store metadata related to raw instrument data in a database in such a way that the original data generated by instruments for specific samples and tests is easy to retrieve.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.4<\/b> The system should be capable of capturing a complete and readable copy of original data and any previous versions of modified data in order to maintain the integrity of that data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD AAVLD Requirements for an AVMDL Sec. 4.10.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.5<\/b> The system should secure raw data such that it can't be deleted and provide version control when data is modified by any user or specific software.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.6<\/b> The SDMS should provide tools for helping a laboratory achieve the U.S. Food and Drug Administration's defined ALCOA principles.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.7<\/b> The SDMS shall provide security and access controls for protecting stored data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.8<\/b> The SDMS shall record an audit trail for each and every record created and modified, using version control.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.9<\/b> The SDMS shall provide proper systems for backing up, restoring, and archiving data for long-term use.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"25._Health_information_technology\">25. Health information technology<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-1\u2013a-4)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.1<\/b> The electronic health record (EHR) module should provide computerized provider order entry (CPOE) functionality for medication orders, laboratory orders, and diagnostic imaging, including making checks for potential drug-drug and drug-allergy interactions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-5)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-11\u2013a-12)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-15)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.2<\/b> The EHR module should allow authorized personnel to record, change, and access patient demographic data, including, but not limited to, race and ethnicity, patient's preferred language, birth sex, current sex, sexual orientation, gender identity, birth date, smoking status, alcohol use, family health history, psychological aspects, social aspects, and behavioral aspects.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-6\u2013a-8)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-10)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-14)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.3<\/b> The EHR module should allow authorized personnel to record, change, and access a patient's active problem list, medication list, medication allergy list, preferred drug list, and implantable device list, incorporating, where appropriate, at a minimum the SNOMED CT nomenclature standard.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-19)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.4<\/b> The EHR module should incorporate configurable, role-based clinical decision support tools capable of allowing authorized personnel to trigger electronic interventions based on liked reference information standardized to Health Level 7 (HL7) Version 3 implementation guides. The reference information should be sourced.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-13)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.5<\/b> The EHR module should be able to identify education resources specific to a patient's active problem and medication lists. The educational resources should be standardized to Health Level 7 (HL7) Version 3 implementation guides.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-1\u2013b-2; b-4\u2013b-5)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.6<\/b> The EHR module should allow authorized personnel to create, view, send, and receive transition of care or referral summaries in such a way that the summary is properly formatted, matched to the correct patient, and reconciled according to the standards and protocols outlined in 45 CFR Part 170.315 (b-1), (b-2), (b-4), and (b-5).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.7<\/b> The EHR module should allow authorized personnel to conduct electronic prescribing actions such as creating, changing, cancelling, and refilling prescriptions, incorporating at least the RxNorm and NCPDP SCRIPT standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-6)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.8<\/b> The EHR module should allow authorized personnel to configure, create, and store data exports, incorporating at least HL7 Version 3 implementation standards, as well as SNOMED CT and ICD-9 standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-7\u2013b-8)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.9<\/b> The EHR module should allow for the secure creation, sending, and receipt of restricted summary records, incorporating HL7 Version 3 implementation standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-9)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.10<\/b> The EHR module should allow authorized personnel to create, record, change, access, and receive care plan information, incorporating HL7 Version 3 implementation standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (c)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.11<\/b> The EHR module should provide a means to record, calculate, import, export, filter, and report on clinical quality measures according to the standards outlined in 45 CFR Part 170.315 (c).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.12<\/b> The EHR module shall provide security and access controls for protecting stored data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.13<\/b> The EHR module shall record an audit trail for each and every record created and modified, using version control.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.14<\/b> The EHR module shall either encrypt electronic health information on end-user devices after use of the technology on the device stops or prevent electronic health information from being stored on end-user devices after use of the technology on the device stops.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-8)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.15<\/b> The EHR module shall ensure that electronically exchanged health information has not been altered during the transfer process, using at least a hashing algorithm secured to SHA-2 or better.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-11)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.16<\/b> The EHR module should be capable of recording patient disclosures made for treatment, payment, and health care operations.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (e-1)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.17<\/b> The EHR module should provide a means for patients and their authorized representatives to view, download, and transmit their personal health information and activity history log from the EHR via an internet-based technology, using the standards outlined in 45 CFR Part 170.315 (e-1).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (e-2\u2013e-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.18<\/b> The EHR module should provide a means for authorized users to securely send messages to and receive messages from patients, at the same time allowing for the recording, accessing, and linking of information shared by the patient electronically (as well as directly).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (f)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.19<\/b> The EHR module should allow vital patient information as it relates to public health to be transmitted to immunization registries, cancer registries, and public health agencies, as well as be accessed after the fact. This includes, but is not limited to, immunization history, surveillance information, laboratory test results, cancer case information, case reports, antimicrobial reporting, and health care survey information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-3\u2013g-5)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.20<\/b> The EHR developer should use user-centered and accessibility-centered design processes for creating and testing the EHR's functionality. A quality management system should be used during these processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-6)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.21<\/b> The EHR module's use of clinical document architecture (CDA) should be demonstrated and verified for conformance to the standards identified in 45 CFR Part 170.315 (g-6).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-7\u2013g-9)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.22<\/b> The EHR module should include an application programming interface (API) that demonstrates the EHR's ability to uniquely identify a patient and corresponding ID\/token in a received records or data category request in order to accurately and securely meet the request for that patient's data. The API should be well documented.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173544\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.091 seconds\nReal time usage: 0.100 seconds\nPreprocessor visited node count: 377\/1000000\nPost\u2010expand include size: 77243\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 20.131 1 -total\n 12.96% 2.609 1 Template:LIMSpec\/Production_management\n 11.73% 2.361 1 Template:LIMSpec\/Environmental_data_management\n 11.17% 2.248 1 Template:LIMSpec\/Veterinary_data_management\n 11.10% 2.234 1 Template:LIMSpec\/Health_information_technology\n 10.88% 2.191 1 Template:LIMSpec\/Scientific_data_management\n 9.85% 1.984 1 Template:LIMSpec\/Public_health_data_management\n 9.80% 1.973 1 Template:LIMSpec\/Forensic_case_and_data_management\n 9.37% 1.887 1 Template:LIMSpec\/Agriculture_and_food_data_management\n 9.11% 1.833 1 Template:LIMSpec\/Statistical_trending_and_control_charts\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11203-0!canonical and timestamp 20221202173544 and revision id 47561. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#19._Agriculture_and_food_data_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#19._Agriculture_and_food_data_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","3a680a3c3df3893b3027dc86b948be58_images":[],"3a680a3c3df3893b3027dc86b948be58_timestamp":1670002544,"5bf95a1f218d7809238a0eb597aff931_type":"article","5bf95a1f218d7809238a0eb597aff931_title":"18. Statistical trending and control charts","5bf95a1f218d7809238a0eb597aff931_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#18._Statistical_trending_and_control_charts","5bf95a1f218d7809238a0eb597aff931_plaintext":"\n\nLII:LIMSpec\/Specialty Laboratory FunctionsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover the specialty requirements that come with working in specific industries such as agriculture, pharmaceutical production, and forensic science. You'll likely notice that most of the content here isn't covered by ASTM E1578-18.\n\n17. Production management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 211.103\r\n21 CFR Part 226.40 (d)\r\nWHO Technical Report Series, #986, Annex 2, 16.4 and 16.20\n\n17.1 The system should be able to calculate and record theoretical and actual percentage of yield at various phases of processing, manufacturing, and packaging.\n\n\n21 CFR Part 211.103\n\n17.2 The system should provide a means for verification and approval of yield calculations before release for reporting.\n\n\n\n21 CFR Part 820.20\r\n\n21 CFR Part 820.40\r\n\n21 CFR Part 820.186\r\n\nE.U. Commission Directive 2003\/94\/EC Article 11\r\n\nWHO Technical Report Series, #986, Annex 2, 1.0\n\n\n17.3 The system shall be able to maintain a production facility's quality system in a specific quality system record, in accordance with regulations and guidance such as 21 CFR Part 820.20 and 820.40 (U.S.), E.U. Commission Directive 2003\/94\/EC Article 11 (E.U.), and WHO Technical Report Series, #986, Annex 2, 1.0 (global).\n\n\n21 CFR Part 820.30\r\n21 CFR Part 820.120 (e)\n\n17.4 The system shall be able to create a design control document capable of recording the details surrounding device development, including control number, physical and performance requirements, final output, review, verification, approval, transfer, changes, and complete design history.\n\n\n21 CFR Part 820.181\r\n21 CFR Part 820.184\n\n17.5 The system shall be able to create a device master and device history record capable of recording all information described in 21 CFR Part 820.181 and 820.184.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 111.255\u2013260\r\n\n21 CFR Part 114.100 (b)\r\n\n21 CFR Part 211.105 (b)\r\n\n21 CFR Part 211.130 (e)\r\n\n21 CFR Part 211.134 (c)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.20 (d)\r\n\n21 CFR Part 211.50 (c)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 225.202\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 820.60\r\n\n21 CFR Part 820.70 (a)\r\n\n21 CFR Part 820.80 (c)\r\n\n21 CFR Part 820.120 (d)\r\n\nBRC GSFS, Issue 8, 6.1.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.1.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 8.1\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.1\r\n\nFDA Hazard Analysis Critical Control Point Principle 2 and 4\r\n\nFDA Hazard Analysis Critical Control Point Principle 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11\r\n\nIFS Food 7, Part 2, 4.2.1.1\r\n\nIFS Food 7, Part 2, 4.18.1\r\n\nIFS PACsecure 2, Part 2, 4.2.1.1\r\n\nIFS PACsecure 2, Part 2, 4.18.1\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (3)\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f\u2013g)\r\n\nWHO Technical Report Series, #986, Annex 2, 15.25\u201330\n\n\n17.6 The system shall be able to create a batch production record capable of recording complete information regarding batch production and control details such as, but not limited to, a unique batch, lot, or production run number; formulation; specific labeling and packaging; production steps; in-process and laboratory control results; the unique identifier of any equipment used; persons performing and\/or supervising operational steps; and the results of any pre-process or post-production inspections.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.100 (e)\r\n\n21 CFR Part 111.205\u2013210\r\n\n21 CFR Part 114.100 (b)\r\n\n21 CFR Part 211.186\r\n\n21 CFR Part 212.50 (b)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nBRC GSFS, Issue 8, 3.6.2\r\n\nBRC GSFS, Issue 8, 9.2.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.1.2\r\n\nFDA Hazard Analysis Critical Control Point Principle 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11\r\n\nIFS Food 7, Part 2, 4.2.1.1\r\n\nIFS PACsecure 2, Part 2, 4.2.1.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 15.22\u201323\n\n\n17.7 The system shall be able to create a master production and control record capable of recording complete information regarding master production and control details.\n\n\n\n21 CFR Part 106.100 (e)\r\n\n21 CFR Part 111.123 (a)\r\n\n21 CFR Part 114.100 (c)\r\n\n21 CFR Part 117.150 (d)\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.186\r\n\n21 CFR Part 212.50 (b)\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nBRC GSFS, Issue 8, 9.2.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 10.3\u20134\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.2\r\n\nIFS Food 7, Part 2, 4.2.1.2\r\n\nIFS Food 7, Part 2, 4.3.x\r\n\nIFS Food 7, Part 2, 5.11\r\n\nIFS PACsecure 2, Part 2, 4.2.1.2\r\n\nIFS PACsecure 2, Part 2, 4.3.x\r\n\nIFS PACsecure 2, Part 2, 5.11\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b)\r\n\nWHO Technical Report Series, #986, Annex 2, 4.0\n\n\n17.8 The system shall require a new or modified master production and control record to be validated, reviewed, and approved before being implemented into production, including allowing that record to be electronically signed by one or more authorized individuals upon approval. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n\n\n\n21 CFR Part 111.123 (a)\r\n\n21 CFR Part 114.100 (c)\r\n\n21 CFR Part 117.150 (d)\r\n\n21 CFR Part 211.22\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 820.70 (b)\r\n\n21 CFR Part 820.75\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 10.3\r\n\nIFS Food 7, Part 2, 4.2.1.2\r\n\nIFS Food 7, Part 2, 4.3.x\r\n\nIFS Food 7, Part 2, 5.11\r\n\nIFS PACsecure 2, Part 2, 4.2.1.2\r\n\nIFS PACsecure 2, Part 2, 4.3.x\r\n\nIFS PACsecure 2, Part 2, 5.11\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b, f)\r\n\nWHO Technical Report Series, #986, Annex 2, 4.0\n\n\n17.9 The system shall require a new or modified production and control record to be validated, reviewed, and approved before being implemented in production. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n\n\n\n21 CFR Part 211.110\r\n\n21 CFR Part 212.50\r\n\n21 CFR Part 820.80 (c)\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\r\n\nISO\/TS 22002-1:2009, 14.3\n\n\n17.10 The system shall be able to indicate if a sample consists of an in-process manufacturing material and track characteristics of the in-process material such as identity, strength, quality, purity, and approval status.\n\n\n21 CFR Part 211.111\n\n17.11 The system shall provide a means to track the amount of time between production processes.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.80\r\n\n21 CFR Part 106.100 (f-6)\r\n\n21 CFR Part 117.420\r\n\n21 CFR Part 211.122 (c)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 212.20 (b)\r\n\n21 CFR Part 212.40 (c) and (e)\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.40 (b)\r\n\n21 CFR Part 226.42\r\n\n21 CFR Part 606.120 (b)\r\n\n21 CFR Part 820.60\r\n\n21 CFR Part 820.80 (b)\r\n\n21 CFR Part 820.120 (b)\r\n\nBRC GSFS, Issue 8, 3.6.1\r\n\nBRC GSFS, Issue 8, 3.9.2\r\n\nBRC GSFS, Issue 8, 5.4.4\r\n\nBRC GSFS, Issue 8, 3.5.1\r\n\nBRC GSFS, Issue 8, 9.5.1\u20132\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17\r\n\nIFS Food 7, Part 2, 4.5.2\r\n\nIFS Food 7, Part 2, 4.18.1\r\n\nIFS PACsecure 2, Part 2, 4.5.2\r\n\nIFS PACsecure 2, Part 2, 4.18.1\r\n\nISO\/TS 22002-1:2009, 9.3\r\n\nISO\/TS 22002-1:2009, 14.2\r\n\nISO\/TS 22002-4:2013, 4.6.3\r\n\nISO\/TS 22002-4:2013, 4.11.2\r\n\nISO\/TS 22002-6:2016, 4.6.3\r\n\nISO\/TS 22002-6:2016, 4.11.2\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nWHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21\r\n\nWHO Technical Report Series, #986, Annex 2, 15.32\u201333\n\n\n17.12 The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, certificates of conformity, shelf life or expiration date, storage location, status of examination, and status of approval for use. Any related specifications for those materials should be able to be linked to the received materials.\n\n\n\n21 CFR Part 211.122 (e)\r\n\n21 CFR Part 211.125 (d)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.42\r\n\nBRC GSFS, Issue 8, 3.5.3\r\n\nBRC GSFS, Issue 8, 9.5.3\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17\r\n\nWHO Technical Report Series, #986, Annex 2, 14.7 and 14.22\r\n\nWHO Technical Report Series, #986, Annex 2, 16.35\n\n\n17.13 The system shall be capable of recording the changing quantity of inventoried non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, labeling, containers, and packaging materials), including batch and lot numbers and, if applicable, details of disposition after completion of production.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.70\r\n\n21 CFR Part 111.113\r\n\n21 CFR Part 111.123 (b)\r\n\n21 CFR Part 114.100 (d)\r\n\n21 CFR Part 120.10\r\n\n21 CFR Part 123.6\r\n\n21 CFR Part 211.122 (e)\r\n\n21 CFR Part 211.125 (d)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.42\r\n\n21 CFR Part 606.100 (c)\r\n\n21 CFR Part 820.80 (d\u2013e)\r\n\n21 CFR Part 820.90\r\n\n21 CFR Part 820.160\r\n\nBRC GSFS, Issue 8, 3.8.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.2\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 23\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\nIFS Food 7, Part 2, 5.7.1\r\n\nIFS Food 7, Part 2, 5.10\r\n\nIFS PACsecure 2, Part 2, 5.7.1\r\n\nIFS PACsecure 2, Part 2, 5.10\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.5\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.7\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.5\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.7\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.5\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.7\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (g)\r\n\nWHO Technical Report Series, #986, Annex 2, 14.4, 14.26, and 14.28\r\n\nWHO Technical Report Series, #986, Annex 2, 15.44\u201345\r\n\nWHO Technical Report Series, #986, Annex 2, 16.36\r\n\nWHO Technical Report Series, #986, Annex 2, 17.18\u201319\n\n\n17.14 The system shall prevent the internal release for distribution of a completed production batch until an authorized individual has determined the batch's conformance to final specifications and has approved it for release. If a batch is nonconforming, the system shall be able to clearly document it as such (so as to not distribute it) and provide a review and disposition process. Such approval, rejection, review, and disposition activities shall be documented.\n\n\n\n21 CFR Part 7 Subpart C\r\n\n21 CFR Part 117.139\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 507.38\r\n\n21 CFR Part 810 Subpart B\r\n\nBRC GSFS, Issue 8, 3.11.2\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.5\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\nIFS Food 7, Part 2, 5.9.2\r\n\nIFS PACsecure 2, Part 2, 5.9.2\r\n\nISO\/TS 22002-1:2009, 15.x\r\n\nISO\/TS 22002-4:2013, 4.12\r\n\nISO\/TS 22002-6:2016, 4.12\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.6.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.6.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.3\r\n\nWHO Technical Report Series, #986, Annex 2, 6.0\r\n\nWHO Technical Report Series, #986, Annex 2, 14.32\n\n\n17.15 The system shall provide a means to track and record recall activities of manufactured product and devices based on lot, batch, or other identifier, including storage location, necessary disposition details, and reconciliation between distributed and recovered quantities.\n\n\n\n21 CFR Part 111.520\r\n\n21 CFR Part 211.165 (f)\r\n\n21 CFR Part 211.204\r\n\n21 CFR Part 212.71 (d)\r\n\n21 CFR Part 820.90 (b-2)\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.6\r\n\nWHO Technical Report Series, #986, Annex 2, 14.29\u201330\n\n\n17.16 The system should allow a completed production batch that has been rejected for use or a returned production batch to be flagged in the system for reprocessing or reworking if it meets relevant criteria.\n\n\n\n21 CFR Part 112.145\r\n\nBRC GSFS, Issue 8, 4.11.8.x\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, I - FSM 19.2\r\n\nISO\/TS 22002-1:2009, 11.5\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.8\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.8\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.8\n\n\n17.17 The system shall support environmental testing protocols for testing the production environment on a scheduled, reportable basis. That support shall include facility and sampling site management functionality that allows for highlighting specific test points in the facility, as well as support for offsite and randomized testing. The system should also allow associated samples, methods, tests, reports, and other documents to clearly indicate they correspond to specific environmental testing protocols.\n\n\n\n18. Statistical trending and control charts \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 820.250\r\n\nAIHA-LAP Policies 2018 2A.7.7.1.3\r\n\nASTM E1578-18 E-10-1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7.2.8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.8\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 9\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\n\n\n18.1 The system should allow authorized users to configure the generation of statistical trending and control charts.\n\n\n\n21 CFR Part 820.250\r\n\nAIHA-LAP Policies 2018 2A.7.7.1.3\r\n\nASTM E1578-18 E-10-2\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7.2.8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.8\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 9\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\n\n\n18.2 The system should allow authorized users to choose specific sample types, tests, and parameters associated with the statistical trending and control charts that can be generated.\n\n\n\n19. Agriculture and food data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nFDA Office of Regulatory Affairs Data Exchange (ORA DX) Program\n\n19.1 The system should be able to create or convert an XML or XLS file to ORA DX template specifications, including the use of ORA DX terminology.\n\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\nUSDA Sampling Procedures for PDP 5.3\r\nUSDA Sampling Procedures for PDP 6.2\n\n19.2 The system shall allow for the assignment of the \"regulatory sample collection\" role and be able to produce a list of individuals in said role, including information such as name, locations assigned, part- or full-time role, and full-time equivalents (if any) used to meet any regulatory requirements.\n\n\nUSDA Sampling Procedures for PDP 5.4\n\n19.3 The system shall allow for the documentation of sampling sites used for normal and regulatory sampling and be able to produce a complete list of such sites on-demand. The documentation should allow for details such as the addition of a unique, never-before-used site code; a region code; demographics; date added to or removed from the system; facility type; sample substrates or commodities available at the site; and relative volume information.\n\n\nUSDA Sampling Procedures for PDP 5.4.12 and 5.4.14\n\n19.4 The system shall allow a site that is no longer active for sampling purposes be designated as inactive, yet be allowed to remain on any generated master list. Additionally, such inactive site shall maintain its unique site number in the event the site becomes reinstated as active.\n\n\n\n21 CFR Part 117.130\u2013135\r\n\n21 CFR Part 120 (throughout)\r\n\n21 CFR Part 123.6\r\n\n21 CFR Part 507, Subpart C\r\n\n61 FR 38806, 9 CFR Part 417.x\r\n\nBRC GSFS, Issue 8, 2.x\r\n\nCodex Alimentarius CXC 1-1969, Ch.2, 3.x\r\n\nE.U. Commission Reg. No. 852\/2004 Article 5\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - HACCP 1.X\r\n\nIFS Food 7, Part 2, 2.2.x\r\n\nIFS PACsecure 2, Part 2, 2.2.x\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.3\n\n\n19.5 The system shall allow for the development and documentation of hazard analysis and critical control points (HACCP) or other regulatory-driven food safety plan steps, as well as the implementation of those CCPs or steps into configurable laboratory workflow.\n\n\n61 FR 38806, 9 CFR Part 417.4\n\n19.6 The system shall require a new or modified HACCP or other regulatory-driven food safety plan be validated, reviewed, and approved before being implemented, including requiring that plan to be electronically signed by one or more authorized individuals upon approval.\n\n\n\n21 CFR Part 106.90\r\n\n21 CFR Part 106.92\r\n\n21 CFR Part 106.94\r\n\n21 CFR Part 106.100 (j)\r\n\nBRC GSFS, Issue 8, 3.4.x\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 20\r\n\nIFS Food 7, Part 2, 5.1\r\n\nIFS PACsecure 2, Part 2, 5.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.4\n\n\n19.7 The system shall allow for the documentation and management of internal and external audit activities, while allowing samples, methods, tests, results, reports, documents, and more to be clearly associated with that corresponding audit activity.\n\n\n\n20. Environmental data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nEPA Metadata Technical Specification\n\n20.1 The system should support metadata requirements set forth by ISO 19115 and the EPA Metadata Technical Specification for reporting and data publishing purposes.\n\n\nEPA ERLN Laboratory Requirements 3.3\n\n20.2 The system should support the manual entry or electronic transfer of EPA analytical service requests (ASRs), along with all the required fields of the ASR, including project identifier, project demographics, sample specifics, sample hazards, reporting requirements, and special requirements.\n\n\nEPA SEDD Specification and Data Element Dictionary v5.2\n\n20.3 The system should support the creation and transfer of Staged Electronic Data Deliverable (SEDD) files.\n\n\n\n40 CFR Part 3.10\r\n\n40 CFR Part 60 (throughout)\r\n\n40 CFR Part 62 (throughout)\r\n\n40 CFR Part 63 (throughout)\n\n\n20.4 The system shall support generating electronic environmental reports (e.g., stationary source emissions tests) in either the EPA's Electronic Reporting Tool (ERT) special spreadsheet format or in an XML file format that complies with EPA-approved XML schema.\n\n\nDoD General Data Validation Guidelines\n\n20.5 The system should support electronic data deliverable (EDD) validation by linking the EDD to its quality assurance project plan (QAPP) and the appropriate stage of validation for the EDD's data type.\n\n\n\n21. Forensic case and data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.4.3\nASTM E1188-11 3.2.3\r\n\nASTM E1188-11 3.4.1\r\n\nASTM E1459-13 2.1\r\n\nASTM E1459-13 4.1.1\u20132\r\n\nASTM E1459-13 4.1.4.2\r\n\nASTM E1459-13 4.2.2\u20133\r\n\nASTM E1492-11 4.1.1\r\n\nASTM E1492-11 4.1.5\n\n\n21.1 The system shall be able to assign each piece of collected evidence and each scene a unique identifier using methodologies such as an ID with an incrementing integer (for sequential evidence numbers) or a user-defined naming format for meeting regulatory requirements.\n\n\nA2LA C223 4.13\r\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.6\u201310\r\nASTM E1492-11 4.1.1\r\n\n\n21.2 The system shall be able to assign each case a unique case identifier that, in addition to an electronic signature, is able to be automatically placed on, at a maximum, each page of the case's associated examination and administration records.\n\n\n\nA2LA C223 4.13\r\n\nASTM E1492-11 4.1.1.1\u20132\r\n\nASTM E1492-11 4.1.4\u20135\r\n\nASTM E1492-11 4.2.2\u20133\r\n\nASTM E1492-11 4.5.1.1\n\n\n21.3 In addition to a unique case number, the system shall provide a means to add additional information to a case file, including, but not limited to, submitting agency, agency case number, date of case receipt, name of recipient, shipping and receipt details, items associated with the case and their unique designators, notes, test data, related reports, and other documentation.\n\n\nASTM E1188-11 (throughout)\r\nASTM E1459-13 (throughout)\r\nASTM E1492-11 4.4.3 and 4.5.1\n\n21.4 The system should be able to document evidence using an ASTM-compliant evidence log, including, but not limited to, unique identifiers, investigator and custodian names, key dates and times, evidence conditions, and storage location.\n\n\nASTM E1492-11 4.3.1.1\n\n21.5 The system should be able to prevent a piece of evidence from being scheduled for destructive testing until an appropriate authorization for such analysis is acquired and documented.\n\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1.1\r\nASTM E1492-11 4.1.2\n\n21.6 The system shall be able to record and maintain chain of custody of evidence that is subdivided in the laboratory in the same way that original evidence items are tracked.\n\n\nCJIS Security Policy 5.1.3\n\n21.7 The system shall be capable of recording the secondary dissemination to an authorized agency or organization of criminal history record information (CHRI) sourced from U.S. Criminal Justice Information Services (CJIS).\n\n\nCJIS Security Policy 5.4.7\n\n21.8 The system shall be able to record all National Crime Information Center (NCIC) and Interstate Identification Index (III) data transactions, clearly identifying the operator and authorized receiving agency or organization. III records shall also identify requester and recipient using a unique identifier.\n\n\nCJIS Security Policy 5.5.6\r\nNIST 800-53, Rev. 5, AC-17(1) \r\n\n\n21.9 If the system provides remote access to authorized users over authorized devices, the remote access shall be monitored, controlled and documented, particularly for privileged functions. If remote access to privileged functions is allowed, virtual escorting that meets CJIS Security Policy 5.5.6 conditions will be required.\n\n\nCJIS Security Policy 5.6.2.1.1.1\u20132\r\nCJIS Security Policy 5.6.2.1.2\u20133\r\nNIST 800-53, Rev. 5, IA-5(1) \r\n\n\n21.10 The system shall be capable of putting into place, in their entirety, either the \"basic password standards\" or \"advanced password standards\" described in CJIS Security Policy 5.6.2.1.1.1 and 5.6.2.1.1.2. If PIN and\/or one-time password is also used, the attributes in 5.6.2.1.2 and 5.6.2.1.3 shall also be required.\n\n\nCJIS Security Policy 5.6.2.2\n\n21.11 If the system supports user-based certificates for authentication, the system shall be configurable enough to require them to be 1. user-specific, not device-specific, 2. used only by one user at any given time, and 3. activated for each use by, e.g., a passphrase or PIN.\n\n\nCJIS Security Policy 5.10.1.2.1\u20132\r\n\nCJIS Security Policy Appendix G.6\r\n\nNIST 800-53, Rev. 5, AC-17(2) \r\n\nNIST 800-53, Rev. 5, SC-13, SC-28, and SC-28(1)\r\n\n\n\n21.12 The system shall allow \"encryption in transit\" and \"encryption at rest\" of criminal justice information (CJI) that meets or exceeds the requirements of CJIS Security Policy 5.10.1.2.1 and 5.10.1.2.2.\n\n\nCJIS Security Policy 5.10.1.5\n\n21.13 If the system is cloud-based, the vendor shall ensure that CJI is stored in databases located within the physical boundaries of APB-member countries and within the legal authority of APB-member agencies. Additionally, the vendor shall agree to not use any metadata derived from unencrypted CJI for commercial, advertising, or other purposes, unless specifically permitted for limited within the service agreement.\n\n\nCJIS Security Policy 5.11.1\u20132\n\n21.14 If the system is cloud-based, the vendor should agree to FBI and CSA compliance and security audits of CJI.\n\n\nCJIS Security Policy 5.10.3.2\r\nCJIS Security Policy Appendix G.1\n\n21.15 If the system is capable of being run in a virtual environment, it shall meet the virtualization requirements set forth in CJIS Security Policy 5.10.3.2 and best practices set forth in CJIS Security Policy Appendix G.1.\n\n\nCJIS Security Policy Appendix G.5\r\nNIST 800-53, Rev. 5, AC-6(4)\r\n\nNIST 800-53, Rev. 5, SC-39\r\n\n\n\n21.16 The system should provide separate processing domains in order to not only allow for more granular allocation of user privileges, but also to prevent one process from modifying the executing code of another process.\n\n\nNIST 800-53, Rev. 5, IA-2(1\u20132), IA-2(12), and IA-8(1)\n\n21.17 The system should support the use of personal identity verification\u2014a U.S. Federal government-wide credential system\u2014and other forms of hardware-based (i.e., public key infrastructure or PKI) token authentication, while electronically verifying those credentials and any configured token quality requirements.\n\n\nA2LA C223 5.4\n\n21.18 The system should support the identification and tagging of infrequently performed forensic tests or analyses in order to alert the analyst and other stakeholders that additional competency verification or method validation is required before performing the test or analysis.\n\n\nA2LA C223 5.9\n\n21.19 The system should allow case records to be scheduled for periodic administrative and technical review by individuals not connected with the case. The conducted review should indicate details such as who conducted the review, what the results were, and when the review was completed. If non-conforming results were discovered, records of determination and resolution should be appended to the case record.\n\n\nA2LA C223 5.9\n\n21.20 The system should be able to document examiner testimony and allow such testimony to be scheduled for periodic evaluation. The conducted evaluation should indicate details such as who conducted the evaluation, what the results were, and when the review was completed. If non-conforming results were discovered, related records of determination and resolution should be maintained in the system.\n\n\n\n22. Clinical and public health data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nCDC PHIN Messaging System\n\n22.1 The system should be capable of interfacing with the Center for Disease Control and Prevention's PHIN Messaging System.\n\n\nACMG Technical Standards for Clinical Genetics Laboratories G1.5\r\n\n\n22.2 The system should support Human Genome Variation Society (HGVS) nomenclature and terminology for sequence variants.\n\n\nCLSI QMS22 2.1.2.3\n\n22.3 The system should be able to collect sufficient test utilization information to make necessity checks on ordered tests against established benchmarks.\n\n\nONC USCDI v2\n\n22.4 The system should support the United States Core Data for Interoperability (USCDI) v2 standard, which in turn supports data interoperability across multiple clinical settings.\n\n\n\n23. Veterinary data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nNAHLN Information Technology System\r\nVeNom Coding Group\r\nVeterinary Terminology Services Laboratory\n\n23.1 The system should support standardized veterinary clinical terminology such as that found in the Veterinary Extension of SNOMED CT and the Veterinary Nomenclature (VeNom) Codes.\n\n\nICAR 15 Data Exchange\r\nVICH GL53\n\n23.2 The system should be able to exchange data, when necessary, in a fashion that meets International Committee for Animal Recording (ICAR) and Veterinary International Conference on Harmonization (VICH) electronic data exchange guidelines.\n\n\nNAHLN HL7 Messaging Quick User Guide\n\n23.3 The system should support National Animal Health Laboratory Network (NAHLN), and, by extension, Health Level 7 (HL7) result messaging.\n\n\n\n24. Scientific data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASTM E1578-18 E-11-1\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.1 The system shall capture raw instrument data and metadata either as an electronic file or directly via RS-232 or TCP\/IP communication.\n\n\nASTM E1578-18 E-11-2\n\n24.2 The scientific data management system (SDMS) should provide a checksum verification of source and destination data and store that verification data in a secure server with controlled access.\n\n\n\nASTM E1578-18 E-11-1\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.3 The system shall store metadata related to raw instrument data in a database in such a way that the original data generated by instruments for specific samples and tests is easy to retrieve.\n\n\nASTM E1578-18 E-11-4\n\n24.4 The system should be capable of capturing a complete and readable copy of original data and any previous versions of modified data in order to maintain the integrity of that data.\n\n\n\nAAVLD AAVLD Requirements for an AVMDL Sec. 4.10.2.3\r\n\nASTM E1578-18 E-11-5\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.5 The system should secure raw data such that it can't be deleted and provide version control when data is modified by any user or specific software.\n\n\nASTM E1578-18 E-11-6\n\n24.6 The SDMS should provide tools for helping a laboratory achieve the U.S. Food and Drug Administration's defined ALCOA principles.\n\n\nASTM E1578-18 E-11-7\n\n24.7 The SDMS shall provide security and access controls for protecting stored data.\n\n\nASTM E1578-18 E-11-8\n\n24.8 The SDMS shall record an audit trail for each and every record created and modified, using version control.\n\n\n45 CFR Part 164.308\r\nASTM E1578-18 E-11-9\n\n24.9 The SDMS shall provide proper systems for backing up, restoring, and archiving data for long-term use.\n\n\n\n25. Health information technology \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n45 CFR Part 170.315 (a-1\u2013a-4)\n\n25.1 The electronic health record (EHR) module should provide computerized provider order entry (CPOE) functionality for medication orders, laboratory orders, and diagnostic imaging, including making checks for potential drug-drug and drug-allergy interactions.\n\n\n45 CFR Part 170.315 (a-5)\r\n45 CFR Part 170.315 (a-11\u2013a-12)\r\n45 CFR Part 170.315 (a-15)\n\n25.2 The EHR module should allow authorized personnel to record, change, and access patient demographic data, including, but not limited to, race and ethnicity, patient's preferred language, birth sex, current sex, sexual orientation, gender identity, birth date, smoking status, alcohol use, family health history, psychological aspects, social aspects, and behavioral aspects.\n\n\n45 CFR Part 170.315 (a-6\u2013a-8)\r\n45 CFR Part 170.315 (a-10)\r\n45 CFR Part 170.315 (a-14)\n\n25.3 The EHR module should allow authorized personnel to record, change, and access a patient's active problem list, medication list, medication allergy list, preferred drug list, and implantable device list, incorporating, where appropriate, at a minimum the SNOMED CT nomenclature standard.\n\n\n45 CFR Part 170.315 (a-19)\n\n25.4 The EHR module should incorporate configurable, role-based clinical decision support tools capable of allowing authorized personnel to trigger electronic interventions based on liked reference information standardized to Health Level 7 (HL7) Version 3 implementation guides. The reference information should be sourced.\n\n\n45 CFR Part 170.315 (a-13)\n\n25.5 The EHR module should be able to identify education resources specific to a patient's active problem and medication lists. The educational resources should be standardized to Health Level 7 (HL7) Version 3 implementation guides.\n\n\n45 CFR Part 170.315 (b-1\u2013b-2; b-4\u2013b-5)\n\n25.6 The EHR module should allow authorized personnel to create, view, send, and receive transition of care or referral summaries in such a way that the summary is properly formatted, matched to the correct patient, and reconciled according to the standards and protocols outlined in 45 CFR Part 170.315 (b-1), (b-2), (b-4), and (b-5).\n\n\n45 CFR Part 170.315 (b-3)\n\n25.7 The EHR module should allow authorized personnel to conduct electronic prescribing actions such as creating, changing, cancelling, and refilling prescriptions, incorporating at least the RxNorm and NCPDP SCRIPT standards.\n\n\n45 CFR Part 170.315 (b-6)\n\n25.8 The EHR module should allow authorized personnel to configure, create, and store data exports, incorporating at least HL7 Version 3 implementation standards, as well as SNOMED CT and ICD-9 standards.\n\n\n45 CFR Part 170.315 (b-7\u2013b-8)\n\n25.9 The EHR module should allow for the secure creation, sending, and receipt of restricted summary records, incorporating HL7 Version 3 implementation standards.\n\n\n45 CFR Part 170.315 (b-9)\n\n25.10 The EHR module should allow authorized personnel to create, record, change, access, and receive care plan information, incorporating HL7 Version 3 implementation standards.\n\n\n45 CFR Part 170.315 (c)\n\n25.11 The EHR module should provide a means to record, calculate, import, export, filter, and report on clinical quality measures according to the standards outlined in 45 CFR Part 170.315 (c).\n\n\n45 CFR Part 170.315 (d)\n\n25.12 The EHR module shall provide security and access controls for protecting stored data.\n\n\n45 CFR Part 170.315 (d)\n\n25.13 The EHR module shall record an audit trail for each and every record created and modified, using version control.\n\n\n45 CFR Part 170.315 (d-7)\n\n25.14 The EHR module shall either encrypt electronic health information on end-user devices after use of the technology on the device stops or prevent electronic health information from being stored on end-user devices after use of the technology on the device stops.\n\n\n45 CFR Part 170.315 (d-8)\n\n25.15 The EHR module shall ensure that electronically exchanged health information has not been altered during the transfer process, using at least a hashing algorithm secured to SHA-2 or better.\n\n\n45 CFR Part 170.315 (d-11)\n\n25.16 The EHR module should be capable of recording patient disclosures made for treatment, payment, and health care operations.\n\n\n45 CFR Part 170.315 (e-1)\n\n25.17 The EHR module should provide a means for patients and their authorized representatives to view, download, and transmit their personal health information and activity history log from the EHR via an internet-based technology, using the standards outlined in 45 CFR Part 170.315 (e-1).\n\n\n45 CFR Part 170.315 (e-2\u2013e-3)\n\n25.18 The EHR module should provide a means for authorized users to securely send messages to and receive messages from patients, at the same time allowing for the recording, accessing, and linking of information shared by the patient electronically (as well as directly).\n\n\n45 CFR Part 170.315 (f)\n\n25.19 The EHR module should allow vital patient information as it relates to public health to be transmitted to immunization registries, cancer registries, and public health agencies, as well as be accessed after the fact. This includes, but is not limited to, immunization history, surveillance information, laboratory test results, cancer case information, case reports, antimicrobial reporting, and health care survey information.\n\n\n45 CFR Part 170.315 (g-3\u2013g-5)\n\n25.20 The EHR developer should use user-centered and accessibility-centered design processes for creating and testing the EHR's functionality. A quality management system should be used during these processes.\n\n\n45 CFR Part 170.315 (g-6)\n\n25.21 The EHR module's use of clinical document architecture (CDA) should be demonstrated and verified for conformance to the standards identified in 45 CFR Part 170.315 (g-6).\n\n\n45 CFR Part 170.315 (g-7\u2013g-9)\n\n25.22 The EHR module should include an application programming interface (API) that demonstrates the EHR's ability to uniquely identify a patient and corresponding ID\/token in a received records or data category request in order to accurately and securely meet the request for that patient's data. The API should be well documented.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#18._Statistical_trending_and_control_charts\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#18._Statistical_trending_and_control_charts<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 2 May 2022, at 20:54.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2,200 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","5bf95a1f218d7809238a0eb597aff931_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Specialty_Laboratory_Functions rootpage-LII_LIMSpec_Specialty_Laboratory_Functions skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Specialty Laboratory Functions<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover the specialty requirements that come with working in specific industries such as agriculture, pharmaceutical production, and <a href=\"https:\/\/www.limswiki.org\/index.php\/Forensic_science\" title=\"Forensic science\" class=\"wiki-link\" data-key=\"415d36a7b65494677b6d2873d5febec1\">forensic science<\/a>. You'll likely notice that most of the content here isn't covered by <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a>.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"17._Production_management\">17. Production management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.103\" target=\"_blank\">21 CFR Part 211.103<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40 (d)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.4 and 16.20<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.1<\/b> The system should be able to calculate and record theoretical and actual percentage of yield at various phases of processing, manufacturing, and packaging.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.103\" target=\"_blank\">21 CFR Part 211.103<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.2<\/b> The system should provide a means for verification and approval of yield calculations before release for reporting.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.20\" target=\"_blank\">21 CFR Part 820.20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.186\" target=\"_blank\">21 CFR Part 820.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 1.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.3<\/b> The system shall be able to maintain a production facility's quality system in a specific quality system record, in accordance with regulations and guidance such as 21 CFR Part 820.20 and 820.40 (U.S.), E.U. Commission Directive 2003\/94\/EC Article 11 (E.U.), and WHO Technical Report Series, #986, Annex 2, 1.0 (global).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.30\" target=\"_blank\">21 CFR Part 820.30<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (e)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.4<\/b> The system shall be able to create a design control document capable of recording the details surrounding device development, including control number, physical and performance requirements, final output, review, verification, approval, transfer, changes, and complete design history.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.181\" target=\"_blank\">21 CFR Part 820.181<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.184\" target=\"_blank\">21 CFR Part 820.184<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.5<\/b> The system shall be able to create a device master and device history record capable of recording all information described in 21 CFR Part 820.181 and 820.184.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.255\u2013260<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.130\" target=\"_blank\">21 CFR Part 211.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.134\" target=\"_blank\">21 CFR Part 211.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.20\" target=\"_blank\">21 CFR Part 211.20 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.50\" target=\"_blank\">21 CFR Part 211.50 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.202\" target=\"_blank\">21 CFR Part 225.202<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.60\" target=\"_blank\">21 CFR Part 820.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 2 and 4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f\u2013g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.25\u201330<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.6<\/b> The system shall be able to create a batch production record capable of recording complete information regarding batch production and control details such as, but not limited to, a unique batch, lot, or production run number; formulation; specific labeling and packaging; production steps; in-process and laboratory control results; the unique identifier of any equipment used; persons performing and\/or supervising operational steps; and the results of any pre-process or post-production inspections.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.205\u2013210<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.186\" target=\"_blank\">21 CFR Part 211.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.22\u201323<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.7<\/b> The system shall be able to create a master production and control record capable of recording complete information regarding master production and control details.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.150 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.186\" target=\"_blank\">21 CFR Part 211.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 10.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.8<\/b> The system shall require a new or modified master production and control record to be validated, reviewed, and approved before being implemented into production, including allowing that record to be electronically signed by one or more authorized individuals upon approval. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.150 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.22\" target=\"_blank\">21 CFR Part 211.22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.75\" target=\"_blank\">21 CFR Part 820.75<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b, f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.9<\/b> The system shall require a new or modified production and control record to be validated, reviewed, and approved before being implemented in production. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 14.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.10<\/b> The system shall be able to indicate if a sample consists of an in-process manufacturing material and track characteristics of the in-process material such as identity, strength, quality, purity, and approval status.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.11<\/b> The system shall provide a means to track the amount of time between production processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (f-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c) and (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.60\" target=\"_blank\">21 CFR Part 820.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.5.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 14.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.32\u201333<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.12<\/b> The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, certificates of conformity, shelf life or expiration date, storage location, status of examination, and status of approval for use. Any related specifications for those materials should be able to be linked to the received materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.125\" target=\"_blank\">21 CFR Part 211.125 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.7 and 14.22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.35<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.13<\/b> The system shall be capable of recording the changing quantity of inventoried non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, labeling, containers, and packaging materials), including batch and lot numbers and, if applicable, details of disposition after completion of production.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.113<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.125\" target=\"_blank\">21 CFR Part 211.125 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (d\u2013e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.90\" target=\"_blank\">21 CFR Part 820.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.160\" target=\"_blank\">21 CFR Part 820.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 23<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.4, 14.26, and 14.28<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.44\u201345<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.36<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.18\u201319<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.14<\/b> The system shall prevent the internal release for distribution of a completed production batch until an authorized individual has determined the batch's conformance to final specifications and has approved it for release. If a batch is nonconforming, the system shall be able to clearly document it as such (so as to not distribute it) and provide a review and disposition process. Such approval, rejection, review, and disposition activities shall be documented.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\/subpart-C\" target=\"_blank\">21 CFR Part 7 Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.139<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.38<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\/subpart-B\" target=\"_blank\">21 CFR Part 810 Subpart B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 15.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 6.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.32<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.15<\/b> The system shall provide a means to track and record recall activities of manufactured product and devices based on lot, batch, or other identifier, including storage location, necessary disposition details, and reconciliation between distributed and recovered quantities.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.520<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.165\" target=\"_blank\">21 CFR Part 211.165 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.204\" target=\"_blank\">21 CFR Part 211.204<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.71\" target=\"_blank\">21 CFR Part 212.71 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.90\" target=\"_blank\">21 CFR Part 820.90 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.29\u201330<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.16<\/b> The system should allow a completed production batch that has been rejected for use or a returned production batch to be flagged in the system for reprocessing or reworking if it meets relevant criteria.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.145<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 4.11.8.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, I - FSM 19.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 11.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.17<\/b> The system shall support environmental testing protocols for testing the production environment on a scheduled, reportable basis. That support shall include facility and sampling site management functionality that allows for highlighting specific test points in the facility, as well as support for offsite and randomized testing. The system should also allow associated samples, methods, tests, reports, and other documents to clearly indicate they correspond to specific environmental testing protocols.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"18._Statistical_trending_and_control_charts\">18. Statistical trending and control charts<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.7.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-10-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>18.1<\/b> The system should allow authorized users to configure the generation of statistical trending and control charts.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.7.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-10-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>18.2<\/b> The system should allow authorized users to choose specific sample types, tests, and parameters associated with the statistical trending and control charts that can be generated.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"19._Agriculture_and_food_data_management\">19. Agriculture and food data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/orapartners.fda.gov\/cs\/groups\/public\/documents\/document\/b2hh\/bmri\/~edisp\/rpohandbook.pdf\" target=\"_blank\">FDA Office of Regulatory Affairs Data Exchange (ORA DX) Program<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.1<\/b> The system should be able to create or convert an XML or XLS file to ORA DX template specifications, including the use of ORA DX terminology.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.2<\/b> The system shall allow for the assignment of the \"regulatory sample collection\" role and be able to produce a list of individuals in said role, including information such as name, locations assigned, part- or full-time role, and full-time equivalents (if any) used to meet any regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.3<\/b> The system shall allow for the documentation of sampling sites used for normal and regulatory sampling and be able to produce a complete list of such sites on-demand. The documentation should allow for details such as the addition of a unique, never-before-used site code; a region code; demographics; date added to or removed from the system; facility type; sample substrates or commodities available at the site; and relative volume information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.4.12 and 5.4.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.4<\/b> The system shall allow a site that is no longer active for sampling purposes be designated as inactive, yet be allowed to remain on any generated master list. Additionally, such inactive site shall maintain its unique site number in the event the site becomes reinstated as active.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.130\u2013135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507, Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.2, 3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - HACCP 1.X<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 2.2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 2.2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>19.5<\/b> The system shall allow for the development and documentation of hazard analysis and critical control points (HACCP) or other regulatory-driven food safety plan steps, as well as the implementation of those CCPs or steps into configurable laboratory workflow.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.6<\/b> The system shall require a new or modified HACCP or other regulatory-driven food safety plan be validated, reviewed, and approved before being implemented, including requiring that plan to be electronically signed by one or more authorized individuals upon approval.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.92<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>19.7<\/b> The system shall allow for the documentation and management of internal and external audit activities, while allowing samples, methods, tests, results, reports, documents, and more to be clearly associated with that corresponding audit activity.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"20._Environmental_data_management\">20. Environmental data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/geospatial\/epa-metadata-technical-specification\" target=\"_blank\">EPA Metadata Technical Specification<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.1<\/b> The system should support metadata requirements set forth by ISO 19115 and the EPA Metadata Technical Specification for reporting and data publishing purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.2<\/b> The system should support the manual entry or electronic transfer of EPA analytical service requests (ASRs), along with all the required fields of the ASR, including project identifier, project demographics, sample specifics, sample hazards, reporting requirements, and special requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/2015-07\/documents\/sedd52_specification.pdf\" target=\"_blank\">EPA SEDD Specification and Data Element Dictionary v5.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.3<\/b> The system should support the creation and transfer of Staged Electronic Data Deliverable (SEDD) files.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.10\" target=\"_blank\">40 CFR Part 3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/60\" target=\"_blank\">40 CFR Part 60 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/62\" target=\"_blank\">40 CFR Part 62 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/63\" target=\"_blank\">40 CFR Part 63 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>20.4<\/b> The system shall support generating electronic environmental reports (e.g., stationary source emissions tests) in either the EPA's Electronic Reporting Tool (ERT) special spreadsheet format or in an XML file format that complies with EPA-approved XML schema.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/denix.osd.mil\/edqw\/documents\/documents\/gen-data-validation-rev1\/\" target=\"_blank\">DoD General Data Validation Guidelines<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.5<\/b> The system should support electronic data deliverable (EDD) validation by linking the EDD to its quality assurance project plan (QAPP) and the appropriate stage of validation for the EDD's data type.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"21._Forensic_case_and_data_management\">21. Forensic case and data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.4.3<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1459-13 2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 4.1.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 4.1.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 4.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.1<\/b> The system shall be able to assign each piece of collected evidence and each scene a unique identifier using methodologies such as an ID with an incrementing integer (for sequential evidence numbers) or a user-defined naming format for meeting regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.6\u201310<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.2<\/b> The system shall be able to assign each case a unique case identifier that, in addition to an electronic signature, is able to be automatically placed on, at a maximum, each page of the case's associated examination and administration records.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.5.1.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.3<\/b> In addition to a unique case number, the system shall provide a means to add additional information to a case file, including, but not limited to, submitting agency, agency case number, date of case receipt, name of recipient, shipping and receipt details, items associated with the case and their unique designators, notes, test data, related reports, and other documentation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 (throughout)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 (throughout)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.4.3 and 4.5.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.4<\/b> The system should be able to document evidence using an ASTM-compliant evidence log, including, but not limited to, unique identifiers, investigator and custodian names, key dates and times, evidence conditions, and storage location.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.1.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.5<\/b> The system should be able to prevent a piece of evidence from being scheduled for destructive testing until an appropriate authorization for such analysis is acquired and documented.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.6<\/b> The system shall be able to record and maintain chain of custody of evidence that is subdivided in the laboratory in the same way that original evidence items are tracked.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.1.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.7<\/b> The system shall be capable of recording the secondary dissemination to an authorized agency or organization of criminal history record information (CHRI) sourced from U.S. Criminal Justice Information Services (CJIS).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.8<\/b> The system shall be able to record all National Crime Information Center (NCIC) and Interstate Identification Index (III) data transactions, clearly identifying the operator and authorized receiving agency or organization. III records shall also identify requester and recipient using a unique identifier.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(1) <\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.9<\/b> If the system provides remote access to authorized users over authorized devices, the remote access shall be monitored, controlled and documented, particularly for privileged functions. If remote access to privileged functions is allowed, virtual escorting that meets CJIS Security Policy 5.5.6 conditions will be required.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.1.1.1\u20132<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.1.2\u20133<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5(1) <\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.10<\/b> The system shall be capable of putting into place, in their entirety, either the \"basic password standards\" or \"advanced password standards\" described in CJIS Security Policy 5.6.2.1.1.1 and 5.6.2.1.1.2. If PIN and\/or one-time password is also used, the attributes in 5.6.2.1.2 and 5.6.2.1.3 shall also be required.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.11<\/b> If the system supports user-based certificates for authentication, the system shall be configurable enough to require them to be 1. user-specific, not device-specific, 2. used only by one user at any given time, and 3. activated for each use by, e.g., a passphrase or PIN.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2.1\u20132<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(2) <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-13, SC-28, and SC-28(1)<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.12<\/b> The system shall allow \"encryption in transit\" and \"encryption at rest\" of criminal justice information (CJI) that meets or exceeds the requirements of CJIS Security Policy 5.10.1.2.1 and 5.10.1.2.2.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.13<\/b> If the system is cloud-based, the vendor shall ensure that CJI is stored in databases located within the physical boundaries of APB-member countries and within the legal authority of APB-member agencies. Additionally, the vendor shall agree to not use any metadata derived from unencrypted CJI for commercial, advertising, or other purposes, unless specifically permitted for limited within the service agreement.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.11.1\u20132<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.14<\/b> If the system is cloud-based, the vendor should agree to FBI and CSA compliance and security audits of CJI.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.3.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.15<\/b> If the system is capable of being run in a virtual environment, it shall meet the virtualization requirements set forth in CJIS Security Policy 5.10.3.2 and best practices set forth in CJIS Security Policy Appendix G.1.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6(4)<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-39<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.16<\/b> The system should provide separate processing domains in order to not only allow for more granular allocation of user privileges, but also to prevent one process from modifying the executing code of another process.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2(1\u20132), IA-2(12), and IA-8(1)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.17<\/b> The system should support the use of personal identity verification\u2014a U.S. Federal government-wide credential system\u2014and other forms of hardware-based (i.e., public key infrastructure or PKI) token authentication, while electronically verifying those credentials and any configured token quality requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.18<\/b> The system should support the identification and tagging of infrequently performed forensic tests or analyses in order to alert the analyst and other stakeholders that additional competency verification or method validation is required before performing the test or analysis.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.19<\/b> The system should allow case records to be scheduled for periodic administrative and technical review by individuals not connected with the case. The conducted review should indicate details such as who conducted the review, what the results were, and when the review was completed. If non-conforming results were discovered, records of determination and resolution should be appended to the case record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.20<\/b> The system should be able to document examiner testimony and allow such testimony to be scheduled for periodic evaluation. The conducted evaluation should indicate details such as who conducted the evaluation, what the results were, and when the review was completed. If non-conforming results were discovered, related records of determination and resolution should be maintained in the system.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"22._Clinical_and_public_health_data_management\">22. Clinical and public health data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/phin\/tools\/phinms\/index.html\" target=\"_blank\">CDC PHIN Messaging System<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.1<\/b> The system should be capable of interfacing with the Center for Disease Control and Prevention's PHIN Messaging System.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.5<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>22.2<\/b> The system should support Human Genome Variation Society (HGVS) nomenclature and terminology for sequence variants.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.3<\/b> The system should be able to collect sufficient test utilization information to make necessity checks on ordered tests against established benchmarks.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healthit.gov\/isa\/united-states-core-data-interoperability-uscdi\" target=\"_blank\">ONC USCDI v2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.4<\/b> The system should support the United States Core Data for Interoperability (USCDI) v2 standard, which in turn supports data interoperability across multiple clinical settings.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"23._Veterinary_data_management\">23. Veterinary data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphis.usda.gov\/aphis\/ourfocus\/animalhealth\/lab-info-services\/nahln\/ct_nahln_it\" target=\"_blank\">NAHLN Information Technology System<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/venomcoding.org\/\" target=\"_blank\">VeNom Coding Group<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vtsl.vetmed.vt.edu\/\" target=\"_blank\">Veterinary Terminology Services Laboratory<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.1<\/b> The system should support standardized veterinary clinical terminology such as that found in the Veterinary Extension of SNOMED CT and the Veterinary Nomenclature (VeNom) Codes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.icar.org\/Guidelines\/15-Data-Exchange.pdf\" target=\"_blank\">ICAR 15 Data Exchange<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vichsec.org\/en\/guidelines\/general\" target=\"_blank\">VICH GL53<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.2<\/b> The system should be able to exchange data, when necessary, in a fashion that meets International Committee for Animal Recording (ICAR) and Veterinary International Conference on Harmonization (VICH) electronic data exchange guidelines.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphis.usda.gov\/animal_health\/nahln\/downloads\/MessagingQuickGuide.pdf\" target=\"_blank\">NAHLN HL7 Messaging Quick User Guide<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.3<\/b> The system should support National Animal Health Laboratory Network (NAHLN), and, by extension, Health Level 7 (HL7) result messaging.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"24._Scientific_data_management\">24. Scientific data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.1<\/b> The system shall capture raw instrument data and metadata either as an electronic file or directly via RS-232 or TCP\/IP communication.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.2<\/b> The scientific data management system (SDMS) should provide a checksum verification of source and destination data and store that verification data in a secure server with controlled access.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.3<\/b> The system shall store metadata related to raw instrument data in a database in such a way that the original data generated by instruments for specific samples and tests is easy to retrieve.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.4<\/b> The system should be capable of capturing a complete and readable copy of original data and any previous versions of modified data in order to maintain the integrity of that data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD AAVLD Requirements for an AVMDL Sec. 4.10.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.5<\/b> The system should secure raw data such that it can't be deleted and provide version control when data is modified by any user or specific software.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.6<\/b> The SDMS should provide tools for helping a laboratory achieve the U.S. Food and Drug Administration's defined ALCOA principles.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.7<\/b> The SDMS shall provide security and access controls for protecting stored data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.8<\/b> The SDMS shall record an audit trail for each and every record created and modified, using version control.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.9<\/b> The SDMS shall provide proper systems for backing up, restoring, and archiving data for long-term use.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"25._Health_information_technology\">25. Health information technology<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-1\u2013a-4)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.1<\/b> The electronic health record (EHR) module should provide computerized provider order entry (CPOE) functionality for medication orders, laboratory orders, and diagnostic imaging, including making checks for potential drug-drug and drug-allergy interactions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-5)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-11\u2013a-12)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-15)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.2<\/b> The EHR module should allow authorized personnel to record, change, and access patient demographic data, including, but not limited to, race and ethnicity, patient's preferred language, birth sex, current sex, sexual orientation, gender identity, birth date, smoking status, alcohol use, family health history, psychological aspects, social aspects, and behavioral aspects.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-6\u2013a-8)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-10)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-14)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.3<\/b> The EHR module should allow authorized personnel to record, change, and access a patient's active problem list, medication list, medication allergy list, preferred drug list, and implantable device list, incorporating, where appropriate, at a minimum the SNOMED CT nomenclature standard.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-19)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.4<\/b> The EHR module should incorporate configurable, role-based clinical decision support tools capable of allowing authorized personnel to trigger electronic interventions based on liked reference information standardized to Health Level 7 (HL7) Version 3 implementation guides. The reference information should be sourced.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-13)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.5<\/b> The EHR module should be able to identify education resources specific to a patient's active problem and medication lists. The educational resources should be standardized to Health Level 7 (HL7) Version 3 implementation guides.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-1\u2013b-2; b-4\u2013b-5)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.6<\/b> The EHR module should allow authorized personnel to create, view, send, and receive transition of care or referral summaries in such a way that the summary is properly formatted, matched to the correct patient, and reconciled according to the standards and protocols outlined in 45 CFR Part 170.315 (b-1), (b-2), (b-4), and (b-5).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.7<\/b> The EHR module should allow authorized personnel to conduct electronic prescribing actions such as creating, changing, cancelling, and refilling prescriptions, incorporating at least the RxNorm and NCPDP SCRIPT standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-6)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.8<\/b> The EHR module should allow authorized personnel to configure, create, and store data exports, incorporating at least HL7 Version 3 implementation standards, as well as SNOMED CT and ICD-9 standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-7\u2013b-8)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.9<\/b> The EHR module should allow for the secure creation, sending, and receipt of restricted summary records, incorporating HL7 Version 3 implementation standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-9)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.10<\/b> The EHR module should allow authorized personnel to create, record, change, access, and receive care plan information, incorporating HL7 Version 3 implementation standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (c)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.11<\/b> The EHR module should provide a means to record, calculate, import, export, filter, and report on clinical quality measures according to the standards outlined in 45 CFR Part 170.315 (c).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.12<\/b> The EHR module shall provide security and access controls for protecting stored data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.13<\/b> The EHR module shall record an audit trail for each and every record created and modified, using version control.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.14<\/b> The EHR module shall either encrypt electronic health information on end-user devices after use of the technology on the device stops or prevent electronic health information from being stored on end-user devices after use of the technology on the device stops.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-8)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.15<\/b> The EHR module shall ensure that electronically exchanged health information has not been altered during the transfer process, using at least a hashing algorithm secured to SHA-2 or better.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-11)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.16<\/b> The EHR module should be capable of recording patient disclosures made for treatment, payment, and health care operations.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (e-1)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.17<\/b> The EHR module should provide a means for patients and their authorized representatives to view, download, and transmit their personal health information and activity history log from the EHR via an internet-based technology, using the standards outlined in 45 CFR Part 170.315 (e-1).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (e-2\u2013e-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.18<\/b> The EHR module should provide a means for authorized users to securely send messages to and receive messages from patients, at the same time allowing for the recording, accessing, and linking of information shared by the patient electronically (as well as directly).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (f)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.19<\/b> The EHR module should allow vital patient information as it relates to public health to be transmitted to immunization registries, cancer registries, and public health agencies, as well as be accessed after the fact. This includes, but is not limited to, immunization history, surveillance information, laboratory test results, cancer case information, case reports, antimicrobial reporting, and health care survey information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-3\u2013g-5)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.20<\/b> The EHR developer should use user-centered and accessibility-centered design processes for creating and testing the EHR's functionality. A quality management system should be used during these processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-6)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.21<\/b> The EHR module's use of clinical document architecture (CDA) should be demonstrated and verified for conformance to the standards identified in 45 CFR Part 170.315 (g-6).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-7\u2013g-9)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.22<\/b> The EHR module should include an application programming interface (API) that demonstrates the EHR's ability to uniquely identify a patient and corresponding ID\/token in a received records or data category request in order to accurately and securely meet the request for that patient's data. The API should be well documented.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173544\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.091 seconds\nReal time usage: 0.100 seconds\nPreprocessor visited node count: 377\/1000000\nPost\u2010expand include size: 77243\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 20.131 1 -total\n 12.96% 2.609 1 Template:LIMSpec\/Production_management\n 11.73% 2.361 1 Template:LIMSpec\/Environmental_data_management\n 11.17% 2.248 1 Template:LIMSpec\/Veterinary_data_management\n 11.10% 2.234 1 Template:LIMSpec\/Health_information_technology\n 10.88% 2.191 1 Template:LIMSpec\/Scientific_data_management\n 9.85% 1.984 1 Template:LIMSpec\/Public_health_data_management\n 9.80% 1.973 1 Template:LIMSpec\/Forensic_case_and_data_management\n 9.37% 1.887 1 Template:LIMSpec\/Agriculture_and_food_data_management\n 9.11% 1.833 1 Template:LIMSpec\/Statistical_trending_and_control_charts\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11203-0!canonical and timestamp 20221202173544 and revision id 47561. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#18._Statistical_trending_and_control_charts\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#18._Statistical_trending_and_control_charts<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","5bf95a1f218d7809238a0eb597aff931_images":[],"5bf95a1f218d7809238a0eb597aff931_timestamp":1670002544,"4a86c66dbb770905efc543883944afb7_type":"article","4a86c66dbb770905efc543883944afb7_title":"17. Production management","4a86c66dbb770905efc543883944afb7_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#17._Production_management","4a86c66dbb770905efc543883944afb7_plaintext":"\n\nLII:LIMSpec\/Specialty Laboratory FunctionsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover the specialty requirements that come with working in specific industries such as agriculture, pharmaceutical production, and forensic science. You'll likely notice that most of the content here isn't covered by ASTM E1578-18.\n\n17. Production management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 211.103\r\n21 CFR Part 226.40 (d)\r\nWHO Technical Report Series, #986, Annex 2, 16.4 and 16.20\n\n17.1 The system should be able to calculate and record theoretical and actual percentage of yield at various phases of processing, manufacturing, and packaging.\n\n\n21 CFR Part 211.103\n\n17.2 The system should provide a means for verification and approval of yield calculations before release for reporting.\n\n\n\n21 CFR Part 820.20\r\n\n21 CFR Part 820.40\r\n\n21 CFR Part 820.186\r\n\nE.U. Commission Directive 2003\/94\/EC Article 11\r\n\nWHO Technical Report Series, #986, Annex 2, 1.0\n\n\n17.3 The system shall be able to maintain a production facility's quality system in a specific quality system record, in accordance with regulations and guidance such as 21 CFR Part 820.20 and 820.40 (U.S.), E.U. Commission Directive 2003\/94\/EC Article 11 (E.U.), and WHO Technical Report Series, #986, Annex 2, 1.0 (global).\n\n\n21 CFR Part 820.30\r\n21 CFR Part 820.120 (e)\n\n17.4 The system shall be able to create a design control document capable of recording the details surrounding device development, including control number, physical and performance requirements, final output, review, verification, approval, transfer, changes, and complete design history.\n\n\n21 CFR Part 820.181\r\n21 CFR Part 820.184\n\n17.5 The system shall be able to create a device master and device history record capable of recording all information described in 21 CFR Part 820.181 and 820.184.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 111.255\u2013260\r\n\n21 CFR Part 114.100 (b)\r\n\n21 CFR Part 211.105 (b)\r\n\n21 CFR Part 211.130 (e)\r\n\n21 CFR Part 211.134 (c)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.20 (d)\r\n\n21 CFR Part 211.50 (c)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 225.202\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 820.60\r\n\n21 CFR Part 820.70 (a)\r\n\n21 CFR Part 820.80 (c)\r\n\n21 CFR Part 820.120 (d)\r\n\nBRC GSFS, Issue 8, 6.1.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.1.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 8.1\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.1\r\n\nFDA Hazard Analysis Critical Control Point Principle 2 and 4\r\n\nFDA Hazard Analysis Critical Control Point Principle 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11\r\n\nIFS Food 7, Part 2, 4.2.1.1\r\n\nIFS Food 7, Part 2, 4.18.1\r\n\nIFS PACsecure 2, Part 2, 4.2.1.1\r\n\nIFS PACsecure 2, Part 2, 4.18.1\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (3)\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f\u2013g)\r\n\nWHO Technical Report Series, #986, Annex 2, 15.25\u201330\n\n\n17.6 The system shall be able to create a batch production record capable of recording complete information regarding batch production and control details such as, but not limited to, a unique batch, lot, or production run number; formulation; specific labeling and packaging; production steps; in-process and laboratory control results; the unique identifier of any equipment used; persons performing and\/or supervising operational steps; and the results of any pre-process or post-production inspections.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.100 (e)\r\n\n21 CFR Part 111.205\u2013210\r\n\n21 CFR Part 114.100 (b)\r\n\n21 CFR Part 211.186\r\n\n21 CFR Part 212.50 (b)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nBRC GSFS, Issue 8, 3.6.2\r\n\nBRC GSFS, Issue 8, 9.2.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.1.2\r\n\nFDA Hazard Analysis Critical Control Point Principle 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11\r\n\nIFS Food 7, Part 2, 4.2.1.1\r\n\nIFS PACsecure 2, Part 2, 4.2.1.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 15.22\u201323\n\n\n17.7 The system shall be able to create a master production and control record capable of recording complete information regarding master production and control details.\n\n\n\n21 CFR Part 106.100 (e)\r\n\n21 CFR Part 111.123 (a)\r\n\n21 CFR Part 114.100 (c)\r\n\n21 CFR Part 117.150 (d)\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.186\r\n\n21 CFR Part 212.50 (b)\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nBRC GSFS, Issue 8, 9.2.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 10.3\u20134\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.2\r\n\nIFS Food 7, Part 2, 4.2.1.2\r\n\nIFS Food 7, Part 2, 4.3.x\r\n\nIFS Food 7, Part 2, 5.11\r\n\nIFS PACsecure 2, Part 2, 4.2.1.2\r\n\nIFS PACsecure 2, Part 2, 4.3.x\r\n\nIFS PACsecure 2, Part 2, 5.11\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b)\r\n\nWHO Technical Report Series, #986, Annex 2, 4.0\n\n\n17.8 The system shall require a new or modified master production and control record to be validated, reviewed, and approved before being implemented into production, including allowing that record to be electronically signed by one or more authorized individuals upon approval. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n\n\n\n21 CFR Part 111.123 (a)\r\n\n21 CFR Part 114.100 (c)\r\n\n21 CFR Part 117.150 (d)\r\n\n21 CFR Part 211.22\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 820.70 (b)\r\n\n21 CFR Part 820.75\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 10.3\r\n\nIFS Food 7, Part 2, 4.2.1.2\r\n\nIFS Food 7, Part 2, 4.3.x\r\n\nIFS Food 7, Part 2, 5.11\r\n\nIFS PACsecure 2, Part 2, 4.2.1.2\r\n\nIFS PACsecure 2, Part 2, 4.3.x\r\n\nIFS PACsecure 2, Part 2, 5.11\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b, f)\r\n\nWHO Technical Report Series, #986, Annex 2, 4.0\n\n\n17.9 The system shall require a new or modified production and control record to be validated, reviewed, and approved before being implemented in production. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n\n\n\n21 CFR Part 211.110\r\n\n21 CFR Part 212.50\r\n\n21 CFR Part 820.80 (c)\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\r\n\nISO\/TS 22002-1:2009, 14.3\n\n\n17.10 The system shall be able to indicate if a sample consists of an in-process manufacturing material and track characteristics of the in-process material such as identity, strength, quality, purity, and approval status.\n\n\n21 CFR Part 211.111\n\n17.11 The system shall provide a means to track the amount of time between production processes.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.80\r\n\n21 CFR Part 106.100 (f-6)\r\n\n21 CFR Part 117.420\r\n\n21 CFR Part 211.122 (c)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 212.20 (b)\r\n\n21 CFR Part 212.40 (c) and (e)\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.40 (b)\r\n\n21 CFR Part 226.42\r\n\n21 CFR Part 606.120 (b)\r\n\n21 CFR Part 820.60\r\n\n21 CFR Part 820.80 (b)\r\n\n21 CFR Part 820.120 (b)\r\n\nBRC GSFS, Issue 8, 3.6.1\r\n\nBRC GSFS, Issue 8, 3.9.2\r\n\nBRC GSFS, Issue 8, 5.4.4\r\n\nBRC GSFS, Issue 8, 3.5.1\r\n\nBRC GSFS, Issue 8, 9.5.1\u20132\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17\r\n\nIFS Food 7, Part 2, 4.5.2\r\n\nIFS Food 7, Part 2, 4.18.1\r\n\nIFS PACsecure 2, Part 2, 4.5.2\r\n\nIFS PACsecure 2, Part 2, 4.18.1\r\n\nISO\/TS 22002-1:2009, 9.3\r\n\nISO\/TS 22002-1:2009, 14.2\r\n\nISO\/TS 22002-4:2013, 4.6.3\r\n\nISO\/TS 22002-4:2013, 4.11.2\r\n\nISO\/TS 22002-6:2016, 4.6.3\r\n\nISO\/TS 22002-6:2016, 4.11.2\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nWHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21\r\n\nWHO Technical Report Series, #986, Annex 2, 15.32\u201333\n\n\n17.12 The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, certificates of conformity, shelf life or expiration date, storage location, status of examination, and status of approval for use. Any related specifications for those materials should be able to be linked to the received materials.\n\n\n\n21 CFR Part 211.122 (e)\r\n\n21 CFR Part 211.125 (d)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.42\r\n\nBRC GSFS, Issue 8, 3.5.3\r\n\nBRC GSFS, Issue 8, 9.5.3\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17\r\n\nWHO Technical Report Series, #986, Annex 2, 14.7 and 14.22\r\n\nWHO Technical Report Series, #986, Annex 2, 16.35\n\n\n17.13 The system shall be capable of recording the changing quantity of inventoried non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, labeling, containers, and packaging materials), including batch and lot numbers and, if applicable, details of disposition after completion of production.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.70\r\n\n21 CFR Part 111.113\r\n\n21 CFR Part 111.123 (b)\r\n\n21 CFR Part 114.100 (d)\r\n\n21 CFR Part 120.10\r\n\n21 CFR Part 123.6\r\n\n21 CFR Part 211.122 (e)\r\n\n21 CFR Part 211.125 (d)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.42\r\n\n21 CFR Part 606.100 (c)\r\n\n21 CFR Part 820.80 (d\u2013e)\r\n\n21 CFR Part 820.90\r\n\n21 CFR Part 820.160\r\n\nBRC GSFS, Issue 8, 3.8.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.2\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 23\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\nIFS Food 7, Part 2, 5.7.1\r\n\nIFS Food 7, Part 2, 5.10\r\n\nIFS PACsecure 2, Part 2, 5.7.1\r\n\nIFS PACsecure 2, Part 2, 5.10\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.5\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.7\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.5\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.7\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.5\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.7\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (g)\r\n\nWHO Technical Report Series, #986, Annex 2, 14.4, 14.26, and 14.28\r\n\nWHO Technical Report Series, #986, Annex 2, 15.44\u201345\r\n\nWHO Technical Report Series, #986, Annex 2, 16.36\r\n\nWHO Technical Report Series, #986, Annex 2, 17.18\u201319\n\n\n17.14 The system shall prevent the internal release for distribution of a completed production batch until an authorized individual has determined the batch's conformance to final specifications and has approved it for release. If a batch is nonconforming, the system shall be able to clearly document it as such (so as to not distribute it) and provide a review and disposition process. Such approval, rejection, review, and disposition activities shall be documented.\n\n\n\n21 CFR Part 7 Subpart C\r\n\n21 CFR Part 117.139\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 507.38\r\n\n21 CFR Part 810 Subpart B\r\n\nBRC GSFS, Issue 8, 3.11.2\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.5\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\nIFS Food 7, Part 2, 5.9.2\r\n\nIFS PACsecure 2, Part 2, 5.9.2\r\n\nISO\/TS 22002-1:2009, 15.x\r\n\nISO\/TS 22002-4:2013, 4.12\r\n\nISO\/TS 22002-6:2016, 4.12\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.6.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.6.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.3\r\n\nWHO Technical Report Series, #986, Annex 2, 6.0\r\n\nWHO Technical Report Series, #986, Annex 2, 14.32\n\n\n17.15 The system shall provide a means to track and record recall activities of manufactured product and devices based on lot, batch, or other identifier, including storage location, necessary disposition details, and reconciliation between distributed and recovered quantities.\n\n\n\n21 CFR Part 111.520\r\n\n21 CFR Part 211.165 (f)\r\n\n21 CFR Part 211.204\r\n\n21 CFR Part 212.71 (d)\r\n\n21 CFR Part 820.90 (b-2)\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.6\r\n\nWHO Technical Report Series, #986, Annex 2, 14.29\u201330\n\n\n17.16 The system should allow a completed production batch that has been rejected for use or a returned production batch to be flagged in the system for reprocessing or reworking if it meets relevant criteria.\n\n\n\n21 CFR Part 112.145\r\n\nBRC GSFS, Issue 8, 4.11.8.x\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, I - FSM 19.2\r\n\nISO\/TS 22002-1:2009, 11.5\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.8\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.8\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.8\n\n\n17.17 The system shall support environmental testing protocols for testing the production environment on a scheduled, reportable basis. That support shall include facility and sampling site management functionality that allows for highlighting specific test points in the facility, as well as support for offsite and randomized testing. The system should also allow associated samples, methods, tests, reports, and other documents to clearly indicate they correspond to specific environmental testing protocols.\n\n\n\n18. Statistical trending and control charts \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 820.250\r\n\nAIHA-LAP Policies 2018 2A.7.7.1.3\r\n\nASTM E1578-18 E-10-1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7.2.8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.8\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 9\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\n\n\n18.1 The system should allow authorized users to configure the generation of statistical trending and control charts.\n\n\n\n21 CFR Part 820.250\r\n\nAIHA-LAP Policies 2018 2A.7.7.1.3\r\n\nASTM E1578-18 E-10-2\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7.2.8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.8\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 9\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\n\n\n18.2 The system should allow authorized users to choose specific sample types, tests, and parameters associated with the statistical trending and control charts that can be generated.\n\n\n\n19. Agriculture and food data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nFDA Office of Regulatory Affairs Data Exchange (ORA DX) Program\n\n19.1 The system should be able to create or convert an XML or XLS file to ORA DX template specifications, including the use of ORA DX terminology.\n\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\nUSDA Sampling Procedures for PDP 5.3\r\nUSDA Sampling Procedures for PDP 6.2\n\n19.2 The system shall allow for the assignment of the \"regulatory sample collection\" role and be able to produce a list of individuals in said role, including information such as name, locations assigned, part- or full-time role, and full-time equivalents (if any) used to meet any regulatory requirements.\n\n\nUSDA Sampling Procedures for PDP 5.4\n\n19.3 The system shall allow for the documentation of sampling sites used for normal and regulatory sampling and be able to produce a complete list of such sites on-demand. The documentation should allow for details such as the addition of a unique, never-before-used site code; a region code; demographics; date added to or removed from the system; facility type; sample substrates or commodities available at the site; and relative volume information.\n\n\nUSDA Sampling Procedures for PDP 5.4.12 and 5.4.14\n\n19.4 The system shall allow a site that is no longer active for sampling purposes be designated as inactive, yet be allowed to remain on any generated master list. Additionally, such inactive site shall maintain its unique site number in the event the site becomes reinstated as active.\n\n\n\n21 CFR Part 117.130\u2013135\r\n\n21 CFR Part 120 (throughout)\r\n\n21 CFR Part 123.6\r\n\n21 CFR Part 507, Subpart C\r\n\n61 FR 38806, 9 CFR Part 417.x\r\n\nBRC GSFS, Issue 8, 2.x\r\n\nCodex Alimentarius CXC 1-1969, Ch.2, 3.x\r\n\nE.U. Commission Reg. No. 852\/2004 Article 5\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - HACCP 1.X\r\n\nIFS Food 7, Part 2, 2.2.x\r\n\nIFS PACsecure 2, Part 2, 2.2.x\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.3\n\n\n19.5 The system shall allow for the development and documentation of hazard analysis and critical control points (HACCP) or other regulatory-driven food safety plan steps, as well as the implementation of those CCPs or steps into configurable laboratory workflow.\n\n\n61 FR 38806, 9 CFR Part 417.4\n\n19.6 The system shall require a new or modified HACCP or other regulatory-driven food safety plan be validated, reviewed, and approved before being implemented, including requiring that plan to be electronically signed by one or more authorized individuals upon approval.\n\n\n\n21 CFR Part 106.90\r\n\n21 CFR Part 106.92\r\n\n21 CFR Part 106.94\r\n\n21 CFR Part 106.100 (j)\r\n\nBRC GSFS, Issue 8, 3.4.x\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 20\r\n\nIFS Food 7, Part 2, 5.1\r\n\nIFS PACsecure 2, Part 2, 5.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.4\n\n\n19.7 The system shall allow for the documentation and management of internal and external audit activities, while allowing samples, methods, tests, results, reports, documents, and more to be clearly associated with that corresponding audit activity.\n\n\n\n20. Environmental data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nEPA Metadata Technical Specification\n\n20.1 The system should support metadata requirements set forth by ISO 19115 and the EPA Metadata Technical Specification for reporting and data publishing purposes.\n\n\nEPA ERLN Laboratory Requirements 3.3\n\n20.2 The system should support the manual entry or electronic transfer of EPA analytical service requests (ASRs), along with all the required fields of the ASR, including project identifier, project demographics, sample specifics, sample hazards, reporting requirements, and special requirements.\n\n\nEPA SEDD Specification and Data Element Dictionary v5.2\n\n20.3 The system should support the creation and transfer of Staged Electronic Data Deliverable (SEDD) files.\n\n\n\n40 CFR Part 3.10\r\n\n40 CFR Part 60 (throughout)\r\n\n40 CFR Part 62 (throughout)\r\n\n40 CFR Part 63 (throughout)\n\n\n20.4 The system shall support generating electronic environmental reports (e.g., stationary source emissions tests) in either the EPA's Electronic Reporting Tool (ERT) special spreadsheet format or in an XML file format that complies with EPA-approved XML schema.\n\n\nDoD General Data Validation Guidelines\n\n20.5 The system should support electronic data deliverable (EDD) validation by linking the EDD to its quality assurance project plan (QAPP) and the appropriate stage of validation for the EDD's data type.\n\n\n\n21. Forensic case and data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.4.3\nASTM E1188-11 3.2.3\r\n\nASTM E1188-11 3.4.1\r\n\nASTM E1459-13 2.1\r\n\nASTM E1459-13 4.1.1\u20132\r\n\nASTM E1459-13 4.1.4.2\r\n\nASTM E1459-13 4.2.2\u20133\r\n\nASTM E1492-11 4.1.1\r\n\nASTM E1492-11 4.1.5\n\n\n21.1 The system shall be able to assign each piece of collected evidence and each scene a unique identifier using methodologies such as an ID with an incrementing integer (for sequential evidence numbers) or a user-defined naming format for meeting regulatory requirements.\n\n\nA2LA C223 4.13\r\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.6\u201310\r\nASTM E1492-11 4.1.1\r\n\n\n21.2 The system shall be able to assign each case a unique case identifier that, in addition to an electronic signature, is able to be automatically placed on, at a maximum, each page of the case's associated examination and administration records.\n\n\n\nA2LA C223 4.13\r\n\nASTM E1492-11 4.1.1.1\u20132\r\n\nASTM E1492-11 4.1.4\u20135\r\n\nASTM E1492-11 4.2.2\u20133\r\n\nASTM E1492-11 4.5.1.1\n\n\n21.3 In addition to a unique case number, the system shall provide a means to add additional information to a case file, including, but not limited to, submitting agency, agency case number, date of case receipt, name of recipient, shipping and receipt details, items associated with the case and their unique designators, notes, test data, related reports, and other documentation.\n\n\nASTM E1188-11 (throughout)\r\nASTM E1459-13 (throughout)\r\nASTM E1492-11 4.4.3 and 4.5.1\n\n21.4 The system should be able to document evidence using an ASTM-compliant evidence log, including, but not limited to, unique identifiers, investigator and custodian names, key dates and times, evidence conditions, and storage location.\n\n\nASTM E1492-11 4.3.1.1\n\n21.5 The system should be able to prevent a piece of evidence from being scheduled for destructive testing until an appropriate authorization for such analysis is acquired and documented.\n\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1.1\r\nASTM E1492-11 4.1.2\n\n21.6 The system shall be able to record and maintain chain of custody of evidence that is subdivided in the laboratory in the same way that original evidence items are tracked.\n\n\nCJIS Security Policy 5.1.3\n\n21.7 The system shall be capable of recording the secondary dissemination to an authorized agency or organization of criminal history record information (CHRI) sourced from U.S. Criminal Justice Information Services (CJIS).\n\n\nCJIS Security Policy 5.4.7\n\n21.8 The system shall be able to record all National Crime Information Center (NCIC) and Interstate Identification Index (III) data transactions, clearly identifying the operator and authorized receiving agency or organization. III records shall also identify requester and recipient using a unique identifier.\n\n\nCJIS Security Policy 5.5.6\r\nNIST 800-53, Rev. 5, AC-17(1) \r\n\n\n21.9 If the system provides remote access to authorized users over authorized devices, the remote access shall be monitored, controlled and documented, particularly for privileged functions. If remote access to privileged functions is allowed, virtual escorting that meets CJIS Security Policy 5.5.6 conditions will be required.\n\n\nCJIS Security Policy 5.6.2.1.1.1\u20132\r\nCJIS Security Policy 5.6.2.1.2\u20133\r\nNIST 800-53, Rev. 5, IA-5(1) \r\n\n\n21.10 The system shall be capable of putting into place, in their entirety, either the \"basic password standards\" or \"advanced password standards\" described in CJIS Security Policy 5.6.2.1.1.1 and 5.6.2.1.1.2. If PIN and\/or one-time password is also used, the attributes in 5.6.2.1.2 and 5.6.2.1.3 shall also be required.\n\n\nCJIS Security Policy 5.6.2.2\n\n21.11 If the system supports user-based certificates for authentication, the system shall be configurable enough to require them to be 1. user-specific, not device-specific, 2. used only by one user at any given time, and 3. activated for each use by, e.g., a passphrase or PIN.\n\n\nCJIS Security Policy 5.10.1.2.1\u20132\r\n\nCJIS Security Policy Appendix G.6\r\n\nNIST 800-53, Rev. 5, AC-17(2) \r\n\nNIST 800-53, Rev. 5, SC-13, SC-28, and SC-28(1)\r\n\n\n\n21.12 The system shall allow \"encryption in transit\" and \"encryption at rest\" of criminal justice information (CJI) that meets or exceeds the requirements of CJIS Security Policy 5.10.1.2.1 and 5.10.1.2.2.\n\n\nCJIS Security Policy 5.10.1.5\n\n21.13 If the system is cloud-based, the vendor shall ensure that CJI is stored in databases located within the physical boundaries of APB-member countries and within the legal authority of APB-member agencies. Additionally, the vendor shall agree to not use any metadata derived from unencrypted CJI for commercial, advertising, or other purposes, unless specifically permitted for limited within the service agreement.\n\n\nCJIS Security Policy 5.11.1\u20132\n\n21.14 If the system is cloud-based, the vendor should agree to FBI and CSA compliance and security audits of CJI.\n\n\nCJIS Security Policy 5.10.3.2\r\nCJIS Security Policy Appendix G.1\n\n21.15 If the system is capable of being run in a virtual environment, it shall meet the virtualization requirements set forth in CJIS Security Policy 5.10.3.2 and best practices set forth in CJIS Security Policy Appendix G.1.\n\n\nCJIS Security Policy Appendix G.5\r\nNIST 800-53, Rev. 5, AC-6(4)\r\n\nNIST 800-53, Rev. 5, SC-39\r\n\n\n\n21.16 The system should provide separate processing domains in order to not only allow for more granular allocation of user privileges, but also to prevent one process from modifying the executing code of another process.\n\n\nNIST 800-53, Rev. 5, IA-2(1\u20132), IA-2(12), and IA-8(1)\n\n21.17 The system should support the use of personal identity verification\u2014a U.S. Federal government-wide credential system\u2014and other forms of hardware-based (i.e., public key infrastructure or PKI) token authentication, while electronically verifying those credentials and any configured token quality requirements.\n\n\nA2LA C223 5.4\n\n21.18 The system should support the identification and tagging of infrequently performed forensic tests or analyses in order to alert the analyst and other stakeholders that additional competency verification or method validation is required before performing the test or analysis.\n\n\nA2LA C223 5.9\n\n21.19 The system should allow case records to be scheduled for periodic administrative and technical review by individuals not connected with the case. The conducted review should indicate details such as who conducted the review, what the results were, and when the review was completed. If non-conforming results were discovered, records of determination and resolution should be appended to the case record.\n\n\nA2LA C223 5.9\n\n21.20 The system should be able to document examiner testimony and allow such testimony to be scheduled for periodic evaluation. The conducted evaluation should indicate details such as who conducted the evaluation, what the results were, and when the review was completed. If non-conforming results were discovered, related records of determination and resolution should be maintained in the system.\n\n\n\n22. Clinical and public health data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nCDC PHIN Messaging System\n\n22.1 The system should be capable of interfacing with the Center for Disease Control and Prevention's PHIN Messaging System.\n\n\nACMG Technical Standards for Clinical Genetics Laboratories G1.5\r\n\n\n22.2 The system should support Human Genome Variation Society (HGVS) nomenclature and terminology for sequence variants.\n\n\nCLSI QMS22 2.1.2.3\n\n22.3 The system should be able to collect sufficient test utilization information to make necessity checks on ordered tests against established benchmarks.\n\n\nONC USCDI v2\n\n22.4 The system should support the United States Core Data for Interoperability (USCDI) v2 standard, which in turn supports data interoperability across multiple clinical settings.\n\n\n\n23. Veterinary data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nNAHLN Information Technology System\r\nVeNom Coding Group\r\nVeterinary Terminology Services Laboratory\n\n23.1 The system should support standardized veterinary clinical terminology such as that found in the Veterinary Extension of SNOMED CT and the Veterinary Nomenclature (VeNom) Codes.\n\n\nICAR 15 Data Exchange\r\nVICH GL53\n\n23.2 The system should be able to exchange data, when necessary, in a fashion that meets International Committee for Animal Recording (ICAR) and Veterinary International Conference on Harmonization (VICH) electronic data exchange guidelines.\n\n\nNAHLN HL7 Messaging Quick User Guide\n\n23.3 The system should support National Animal Health Laboratory Network (NAHLN), and, by extension, Health Level 7 (HL7) result messaging.\n\n\n\n24. Scientific data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASTM E1578-18 E-11-1\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.1 The system shall capture raw instrument data and metadata either as an electronic file or directly via RS-232 or TCP\/IP communication.\n\n\nASTM E1578-18 E-11-2\n\n24.2 The scientific data management system (SDMS) should provide a checksum verification of source and destination data and store that verification data in a secure server with controlled access.\n\n\n\nASTM E1578-18 E-11-1\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.3 The system shall store metadata related to raw instrument data in a database in such a way that the original data generated by instruments for specific samples and tests is easy to retrieve.\n\n\nASTM E1578-18 E-11-4\n\n24.4 The system should be capable of capturing a complete and readable copy of original data and any previous versions of modified data in order to maintain the integrity of that data.\n\n\n\nAAVLD AAVLD Requirements for an AVMDL Sec. 4.10.2.3\r\n\nASTM E1578-18 E-11-5\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.5 The system should secure raw data such that it can't be deleted and provide version control when data is modified by any user or specific software.\n\n\nASTM E1578-18 E-11-6\n\n24.6 The SDMS should provide tools for helping a laboratory achieve the U.S. Food and Drug Administration's defined ALCOA principles.\n\n\nASTM E1578-18 E-11-7\n\n24.7 The SDMS shall provide security and access controls for protecting stored data.\n\n\nASTM E1578-18 E-11-8\n\n24.8 The SDMS shall record an audit trail for each and every record created and modified, using version control.\n\n\n45 CFR Part 164.308\r\nASTM E1578-18 E-11-9\n\n24.9 The SDMS shall provide proper systems for backing up, restoring, and archiving data for long-term use.\n\n\n\n25. Health information technology \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n45 CFR Part 170.315 (a-1\u2013a-4)\n\n25.1 The electronic health record (EHR) module should provide computerized provider order entry (CPOE) functionality for medication orders, laboratory orders, and diagnostic imaging, including making checks for potential drug-drug and drug-allergy interactions.\n\n\n45 CFR Part 170.315 (a-5)\r\n45 CFR Part 170.315 (a-11\u2013a-12)\r\n45 CFR Part 170.315 (a-15)\n\n25.2 The EHR module should allow authorized personnel to record, change, and access patient demographic data, including, but not limited to, race and ethnicity, patient's preferred language, birth sex, current sex, sexual orientation, gender identity, birth date, smoking status, alcohol use, family health history, psychological aspects, social aspects, and behavioral aspects.\n\n\n45 CFR Part 170.315 (a-6\u2013a-8)\r\n45 CFR Part 170.315 (a-10)\r\n45 CFR Part 170.315 (a-14)\n\n25.3 The EHR module should allow authorized personnel to record, change, and access a patient's active problem list, medication list, medication allergy list, preferred drug list, and implantable device list, incorporating, where appropriate, at a minimum the SNOMED CT nomenclature standard.\n\n\n45 CFR Part 170.315 (a-19)\n\n25.4 The EHR module should incorporate configurable, role-based clinical decision support tools capable of allowing authorized personnel to trigger electronic interventions based on liked reference information standardized to Health Level 7 (HL7) Version 3 implementation guides. The reference information should be sourced.\n\n\n45 CFR Part 170.315 (a-13)\n\n25.5 The EHR module should be able to identify education resources specific to a patient's active problem and medication lists. The educational resources should be standardized to Health Level 7 (HL7) Version 3 implementation guides.\n\n\n45 CFR Part 170.315 (b-1\u2013b-2; b-4\u2013b-5)\n\n25.6 The EHR module should allow authorized personnel to create, view, send, and receive transition of care or referral summaries in such a way that the summary is properly formatted, matched to the correct patient, and reconciled according to the standards and protocols outlined in 45 CFR Part 170.315 (b-1), (b-2), (b-4), and (b-5).\n\n\n45 CFR Part 170.315 (b-3)\n\n25.7 The EHR module should allow authorized personnel to conduct electronic prescribing actions such as creating, changing, cancelling, and refilling prescriptions, incorporating at least the RxNorm and NCPDP SCRIPT standards.\n\n\n45 CFR Part 170.315 (b-6)\n\n25.8 The EHR module should allow authorized personnel to configure, create, and store data exports, incorporating at least HL7 Version 3 implementation standards, as well as SNOMED CT and ICD-9 standards.\n\n\n45 CFR Part 170.315 (b-7\u2013b-8)\n\n25.9 The EHR module should allow for the secure creation, sending, and receipt of restricted summary records, incorporating HL7 Version 3 implementation standards.\n\n\n45 CFR Part 170.315 (b-9)\n\n25.10 The EHR module should allow authorized personnel to create, record, change, access, and receive care plan information, incorporating HL7 Version 3 implementation standards.\n\n\n45 CFR Part 170.315 (c)\n\n25.11 The EHR module should provide a means to record, calculate, import, export, filter, and report on clinical quality measures according to the standards outlined in 45 CFR Part 170.315 (c).\n\n\n45 CFR Part 170.315 (d)\n\n25.12 The EHR module shall provide security and access controls for protecting stored data.\n\n\n45 CFR Part 170.315 (d)\n\n25.13 The EHR module shall record an audit trail for each and every record created and modified, using version control.\n\n\n45 CFR Part 170.315 (d-7)\n\n25.14 The EHR module shall either encrypt electronic health information on end-user devices after use of the technology on the device stops or prevent electronic health information from being stored on end-user devices after use of the technology on the device stops.\n\n\n45 CFR Part 170.315 (d-8)\n\n25.15 The EHR module shall ensure that electronically exchanged health information has not been altered during the transfer process, using at least a hashing algorithm secured to SHA-2 or better.\n\n\n45 CFR Part 170.315 (d-11)\n\n25.16 The EHR module should be capable of recording patient disclosures made for treatment, payment, and health care operations.\n\n\n45 CFR Part 170.315 (e-1)\n\n25.17 The EHR module should provide a means for patients and their authorized representatives to view, download, and transmit their personal health information and activity history log from the EHR via an internet-based technology, using the standards outlined in 45 CFR Part 170.315 (e-1).\n\n\n45 CFR Part 170.315 (e-2\u2013e-3)\n\n25.18 The EHR module should provide a means for authorized users to securely send messages to and receive messages from patients, at the same time allowing for the recording, accessing, and linking of information shared by the patient electronically (as well as directly).\n\n\n45 CFR Part 170.315 (f)\n\n25.19 The EHR module should allow vital patient information as it relates to public health to be transmitted to immunization registries, cancer registries, and public health agencies, as well as be accessed after the fact. This includes, but is not limited to, immunization history, surveillance information, laboratory test results, cancer case information, case reports, antimicrobial reporting, and health care survey information.\n\n\n45 CFR Part 170.315 (g-3\u2013g-5)\n\n25.20 The EHR developer should use user-centered and accessibility-centered design processes for creating and testing the EHR's functionality. A quality management system should be used during these processes.\n\n\n45 CFR Part 170.315 (g-6)\n\n25.21 The EHR module's use of clinical document architecture (CDA) should be demonstrated and verified for conformance to the standards identified in 45 CFR Part 170.315 (g-6).\n\n\n45 CFR Part 170.315 (g-7\u2013g-9)\n\n25.22 The EHR module should include an application programming interface (API) that demonstrates the EHR's ability to uniquely identify a patient and corresponding ID\/token in a received records or data category request in order to accurately and securely meet the request for that patient's data. The API should be well documented.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#17._Production_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#17._Production_management<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 2 May 2022, at 20:54.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2,200 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","4a86c66dbb770905efc543883944afb7_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Specialty_Laboratory_Functions rootpage-LII_LIMSpec_Specialty_Laboratory_Functions skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Specialty Laboratory Functions<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover the specialty requirements that come with working in specific industries such as agriculture, pharmaceutical production, and <a href=\"https:\/\/www.limswiki.org\/index.php\/Forensic_science\" title=\"Forensic science\" class=\"wiki-link\" data-key=\"415d36a7b65494677b6d2873d5febec1\">forensic science<\/a>. You'll likely notice that most of the content here isn't covered by <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a>.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"17._Production_management\">17. Production management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.103\" target=\"_blank\">21 CFR Part 211.103<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40 (d)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.4 and 16.20<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.1<\/b> The system should be able to calculate and record theoretical and actual percentage of yield at various phases of processing, manufacturing, and packaging.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.103\" target=\"_blank\">21 CFR Part 211.103<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.2<\/b> The system should provide a means for verification and approval of yield calculations before release for reporting.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.20\" target=\"_blank\">21 CFR Part 820.20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.186\" target=\"_blank\">21 CFR Part 820.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 1.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.3<\/b> The system shall be able to maintain a production facility's quality system in a specific quality system record, in accordance with regulations and guidance such as 21 CFR Part 820.20 and 820.40 (U.S.), E.U. Commission Directive 2003\/94\/EC Article 11 (E.U.), and WHO Technical Report Series, #986, Annex 2, 1.0 (global).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.30\" target=\"_blank\">21 CFR Part 820.30<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (e)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.4<\/b> The system shall be able to create a design control document capable of recording the details surrounding device development, including control number, physical and performance requirements, final output, review, verification, approval, transfer, changes, and complete design history.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.181\" target=\"_blank\">21 CFR Part 820.181<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.184\" target=\"_blank\">21 CFR Part 820.184<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.5<\/b> The system shall be able to create a device master and device history record capable of recording all information described in 21 CFR Part 820.181 and 820.184.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.255\u2013260<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.130\" target=\"_blank\">21 CFR Part 211.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.134\" target=\"_blank\">21 CFR Part 211.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.20\" target=\"_blank\">21 CFR Part 211.20 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.50\" target=\"_blank\">21 CFR Part 211.50 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.202\" target=\"_blank\">21 CFR Part 225.202<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.60\" target=\"_blank\">21 CFR Part 820.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 2 and 4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f\u2013g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.25\u201330<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.6<\/b> The system shall be able to create a batch production record capable of recording complete information regarding batch production and control details such as, but not limited to, a unique batch, lot, or production run number; formulation; specific labeling and packaging; production steps; in-process and laboratory control results; the unique identifier of any equipment used; persons performing and\/or supervising operational steps; and the results of any pre-process or post-production inspections.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.205\u2013210<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.186\" target=\"_blank\">21 CFR Part 211.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.22\u201323<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.7<\/b> The system shall be able to create a master production and control record capable of recording complete information regarding master production and control details.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.150 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.186\" target=\"_blank\">21 CFR Part 211.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 10.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.8<\/b> The system shall require a new or modified master production and control record to be validated, reviewed, and approved before being implemented into production, including allowing that record to be electronically signed by one or more authorized individuals upon approval. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.150 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.22\" target=\"_blank\">21 CFR Part 211.22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.75\" target=\"_blank\">21 CFR Part 820.75<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b, f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.9<\/b> The system shall require a new or modified production and control record to be validated, reviewed, and approved before being implemented in production. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 14.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.10<\/b> The system shall be able to indicate if a sample consists of an in-process manufacturing material and track characteristics of the in-process material such as identity, strength, quality, purity, and approval status.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.11<\/b> The system shall provide a means to track the amount of time between production processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (f-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c) and (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.60\" target=\"_blank\">21 CFR Part 820.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.5.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 14.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.32\u201333<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.12<\/b> The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, certificates of conformity, shelf life or expiration date, storage location, status of examination, and status of approval for use. Any related specifications for those materials should be able to be linked to the received materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.125\" target=\"_blank\">21 CFR Part 211.125 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.7 and 14.22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.35<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.13<\/b> The system shall be capable of recording the changing quantity of inventoried non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, labeling, containers, and packaging materials), including batch and lot numbers and, if applicable, details of disposition after completion of production.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.113<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.125\" target=\"_blank\">21 CFR Part 211.125 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (d\u2013e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.90\" target=\"_blank\">21 CFR Part 820.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.160\" target=\"_blank\">21 CFR Part 820.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 23<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.4, 14.26, and 14.28<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.44\u201345<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.36<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.18\u201319<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.14<\/b> The system shall prevent the internal release for distribution of a completed production batch until an authorized individual has determined the batch's conformance to final specifications and has approved it for release. If a batch is nonconforming, the system shall be able to clearly document it as such (so as to not distribute it) and provide a review and disposition process. Such approval, rejection, review, and disposition activities shall be documented.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\/subpart-C\" target=\"_blank\">21 CFR Part 7 Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.139<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.38<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\/subpart-B\" target=\"_blank\">21 CFR Part 810 Subpart B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 15.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 6.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.32<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.15<\/b> The system shall provide a means to track and record recall activities of manufactured product and devices based on lot, batch, or other identifier, including storage location, necessary disposition details, and reconciliation between distributed and recovered quantities.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.520<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.165\" target=\"_blank\">21 CFR Part 211.165 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.204\" target=\"_blank\">21 CFR Part 211.204<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.71\" target=\"_blank\">21 CFR Part 212.71 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.90\" target=\"_blank\">21 CFR Part 820.90 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.29\u201330<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.16<\/b> The system should allow a completed production batch that has been rejected for use or a returned production batch to be flagged in the system for reprocessing or reworking if it meets relevant criteria.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.145<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 4.11.8.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, I - FSM 19.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 11.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.17<\/b> The system shall support environmental testing protocols for testing the production environment on a scheduled, reportable basis. That support shall include facility and sampling site management functionality that allows for highlighting specific test points in the facility, as well as support for offsite and randomized testing. The system should also allow associated samples, methods, tests, reports, and other documents to clearly indicate they correspond to specific environmental testing protocols.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"18._Statistical_trending_and_control_charts\">18. Statistical trending and control charts<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.7.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-10-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>18.1<\/b> The system should allow authorized users to configure the generation of statistical trending and control charts.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.7.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-10-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>18.2<\/b> The system should allow authorized users to choose specific sample types, tests, and parameters associated with the statistical trending and control charts that can be generated.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"19._Agriculture_and_food_data_management\">19. Agriculture and food data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/orapartners.fda.gov\/cs\/groups\/public\/documents\/document\/b2hh\/bmri\/~edisp\/rpohandbook.pdf\" target=\"_blank\">FDA Office of Regulatory Affairs Data Exchange (ORA DX) Program<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.1<\/b> The system should be able to create or convert an XML or XLS file to ORA DX template specifications, including the use of ORA DX terminology.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.2<\/b> The system shall allow for the assignment of the \"regulatory sample collection\" role and be able to produce a list of individuals in said role, including information such as name, locations assigned, part- or full-time role, and full-time equivalents (if any) used to meet any regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.3<\/b> The system shall allow for the documentation of sampling sites used for normal and regulatory sampling and be able to produce a complete list of such sites on-demand. The documentation should allow for details such as the addition of a unique, never-before-used site code; a region code; demographics; date added to or removed from the system; facility type; sample substrates or commodities available at the site; and relative volume information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.4.12 and 5.4.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.4<\/b> The system shall allow a site that is no longer active for sampling purposes be designated as inactive, yet be allowed to remain on any generated master list. Additionally, such inactive site shall maintain its unique site number in the event the site becomes reinstated as active.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.130\u2013135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507, Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.2, 3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - HACCP 1.X<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 2.2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 2.2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>19.5<\/b> The system shall allow for the development and documentation of hazard analysis and critical control points (HACCP) or other regulatory-driven food safety plan steps, as well as the implementation of those CCPs or steps into configurable laboratory workflow.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.6<\/b> The system shall require a new or modified HACCP or other regulatory-driven food safety plan be validated, reviewed, and approved before being implemented, including requiring that plan to be electronically signed by one or more authorized individuals upon approval.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.92<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>19.7<\/b> The system shall allow for the documentation and management of internal and external audit activities, while allowing samples, methods, tests, results, reports, documents, and more to be clearly associated with that corresponding audit activity.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"20._Environmental_data_management\">20. Environmental data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/geospatial\/epa-metadata-technical-specification\" target=\"_blank\">EPA Metadata Technical Specification<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.1<\/b> The system should support metadata requirements set forth by ISO 19115 and the EPA Metadata Technical Specification for reporting and data publishing purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.2<\/b> The system should support the manual entry or electronic transfer of EPA analytical service requests (ASRs), along with all the required fields of the ASR, including project identifier, project demographics, sample specifics, sample hazards, reporting requirements, and special requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/2015-07\/documents\/sedd52_specification.pdf\" target=\"_blank\">EPA SEDD Specification and Data Element Dictionary v5.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.3<\/b> The system should support the creation and transfer of Staged Electronic Data Deliverable (SEDD) files.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.10\" target=\"_blank\">40 CFR Part 3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/60\" target=\"_blank\">40 CFR Part 60 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/62\" target=\"_blank\">40 CFR Part 62 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/63\" target=\"_blank\">40 CFR Part 63 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>20.4<\/b> The system shall support generating electronic environmental reports (e.g., stationary source emissions tests) in either the EPA's Electronic Reporting Tool (ERT) special spreadsheet format or in an XML file format that complies with EPA-approved XML schema.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/denix.osd.mil\/edqw\/documents\/documents\/gen-data-validation-rev1\/\" target=\"_blank\">DoD General Data Validation Guidelines<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>20.5<\/b> The system should support electronic data deliverable (EDD) validation by linking the EDD to its quality assurance project plan (QAPP) and the appropriate stage of validation for the EDD's data type.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"21._Forensic_case_and_data_management\">21. Forensic case and data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.4.3<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1459-13 2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 4.1.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 4.1.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 4.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.1<\/b> The system shall be able to assign each piece of collected evidence and each scene a unique identifier using methodologies such as an ID with an incrementing integer (for sequential evidence numbers) or a user-defined naming format for meeting regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.6\u201310<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.2<\/b> The system shall be able to assign each case a unique case identifier that, in addition to an electronic signature, is able to be automatically placed on, at a maximum, each page of the case's associated examination and administration records.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.5.1.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.3<\/b> In addition to a unique case number, the system shall provide a means to add additional information to a case file, including, but not limited to, submitting agency, agency case number, date of case receipt, name of recipient, shipping and receipt details, items associated with the case and their unique designators, notes, test data, related reports, and other documentation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 (throughout)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13 (throughout)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.4.3 and 4.5.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.4<\/b> The system should be able to document evidence using an ASTM-compliant evidence log, including, but not limited to, unique identifiers, investigator and custodian names, key dates and times, evidence conditions, and storage location.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.1.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.5<\/b> The system should be able to prevent a piece of evidence from being scheduled for destructive testing until an appropriate authorization for such analysis is acquired and documented.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.6<\/b> The system shall be able to record and maintain chain of custody of evidence that is subdivided in the laboratory in the same way that original evidence items are tracked.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.1.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.7<\/b> The system shall be capable of recording the secondary dissemination to an authorized agency or organization of criminal history record information (CHRI) sourced from U.S. Criminal Justice Information Services (CJIS).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.8<\/b> The system shall be able to record all National Crime Information Center (NCIC) and Interstate Identification Index (III) data transactions, clearly identifying the operator and authorized receiving agency or organization. III records shall also identify requester and recipient using a unique identifier.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(1) <\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.9<\/b> If the system provides remote access to authorized users over authorized devices, the remote access shall be monitored, controlled and documented, particularly for privileged functions. If remote access to privileged functions is allowed, virtual escorting that meets CJIS Security Policy 5.5.6 conditions will be required.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.1.1.1\u20132<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.1.2\u20133<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5(1) <\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.10<\/b> The system shall be capable of putting into place, in their entirety, either the \"basic password standards\" or \"advanced password standards\" described in CJIS Security Policy 5.6.2.1.1.1 and 5.6.2.1.1.2. If PIN and\/or one-time password is also used, the attributes in 5.6.2.1.2 and 5.6.2.1.3 shall also be required.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.11<\/b> If the system supports user-based certificates for authentication, the system shall be configurable enough to require them to be 1. user-specific, not device-specific, 2. used only by one user at any given time, and 3. activated for each use by, e.g., a passphrase or PIN.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2.1\u20132<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(2) <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-13, SC-28, and SC-28(1)<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.12<\/b> The system shall allow \"encryption in transit\" and \"encryption at rest\" of criminal justice information (CJI) that meets or exceeds the requirements of CJIS Security Policy 5.10.1.2.1 and 5.10.1.2.2.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.13<\/b> If the system is cloud-based, the vendor shall ensure that CJI is stored in databases located within the physical boundaries of APB-member countries and within the legal authority of APB-member agencies. Additionally, the vendor shall agree to not use any metadata derived from unencrypted CJI for commercial, advertising, or other purposes, unless specifically permitted for limited within the service agreement.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.11.1\u20132<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.14<\/b> If the system is cloud-based, the vendor should agree to FBI and CSA compliance and security audits of CJI.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.3.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.15<\/b> If the system is capable of being run in a virtual environment, it shall meet the virtualization requirements set forth in CJIS Security Policy 5.10.3.2 and best practices set forth in CJIS Security Policy Appendix G.1.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6(4)<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-39<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.16<\/b> The system should provide separate processing domains in order to not only allow for more granular allocation of user privileges, but also to prevent one process from modifying the executing code of another process.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2(1\u20132), IA-2(12), and IA-8(1)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.17<\/b> The system should support the use of personal identity verification\u2014a U.S. Federal government-wide credential system\u2014and other forms of hardware-based (i.e., public key infrastructure or PKI) token authentication, while electronically verifying those credentials and any configured token quality requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.18<\/b> The system should support the identification and tagging of infrequently performed forensic tests or analyses in order to alert the analyst and other stakeholders that additional competency verification or method validation is required before performing the test or analysis.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.19<\/b> The system should allow case records to be scheduled for periodic administrative and technical review by individuals not connected with the case. The conducted review should indicate details such as who conducted the review, what the results were, and when the review was completed. If non-conforming results were discovered, records of determination and resolution should be appended to the case record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.20<\/b> The system should be able to document examiner testimony and allow such testimony to be scheduled for periodic evaluation. The conducted evaluation should indicate details such as who conducted the evaluation, what the results were, and when the review was completed. If non-conforming results were discovered, related records of determination and resolution should be maintained in the system.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"22._Clinical_and_public_health_data_management\">22. Clinical and public health data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/phin\/tools\/phinms\/index.html\" target=\"_blank\">CDC PHIN Messaging System<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.1<\/b> The system should be capable of interfacing with the Center for Disease Control and Prevention's PHIN Messaging System.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.5<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>22.2<\/b> The system should support Human Genome Variation Society (HGVS) nomenclature and terminology for sequence variants.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.3<\/b> The system should be able to collect sufficient test utilization information to make necessity checks on ordered tests against established benchmarks.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healthit.gov\/isa\/united-states-core-data-interoperability-uscdi\" target=\"_blank\">ONC USCDI v2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.4<\/b> The system should support the United States Core Data for Interoperability (USCDI) v2 standard, which in turn supports data interoperability across multiple clinical settings.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"23._Veterinary_data_management\">23. Veterinary data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphis.usda.gov\/aphis\/ourfocus\/animalhealth\/lab-info-services\/nahln\/ct_nahln_it\" target=\"_blank\">NAHLN Information Technology System<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/venomcoding.org\/\" target=\"_blank\">VeNom Coding Group<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vtsl.vetmed.vt.edu\/\" target=\"_blank\">Veterinary Terminology Services Laboratory<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.1<\/b> The system should support standardized veterinary clinical terminology such as that found in the Veterinary Extension of SNOMED CT and the Veterinary Nomenclature (VeNom) Codes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.icar.org\/Guidelines\/15-Data-Exchange.pdf\" target=\"_blank\">ICAR 15 Data Exchange<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vichsec.org\/en\/guidelines\/general\" target=\"_blank\">VICH GL53<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.2<\/b> The system should be able to exchange data, when necessary, in a fashion that meets International Committee for Animal Recording (ICAR) and Veterinary International Conference on Harmonization (VICH) electronic data exchange guidelines.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphis.usda.gov\/animal_health\/nahln\/downloads\/MessagingQuickGuide.pdf\" target=\"_blank\">NAHLN HL7 Messaging Quick User Guide<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.3<\/b> The system should support National Animal Health Laboratory Network (NAHLN), and, by extension, Health Level 7 (HL7) result messaging.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"24._Scientific_data_management\">24. Scientific data management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.1<\/b> The system shall capture raw instrument data and metadata either as an electronic file or directly via RS-232 or TCP\/IP communication.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.2<\/b> The scientific data management system (SDMS) should provide a checksum verification of source and destination data and store that verification data in a secure server with controlled access.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.3<\/b> The system shall store metadata related to raw instrument data in a database in such a way that the original data generated by instruments for specific samples and tests is easy to retrieve.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.4<\/b> The system should be capable of capturing a complete and readable copy of original data and any previous versions of modified data in order to maintain the integrity of that data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD AAVLD Requirements for an AVMDL Sec. 4.10.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.5<\/b> The system should secure raw data such that it can't be deleted and provide version control when data is modified by any user or specific software.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.6<\/b> The SDMS should provide tools for helping a laboratory achieve the U.S. Food and Drug Administration's defined ALCOA principles.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.7<\/b> The SDMS shall provide security and access controls for protecting stored data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.8<\/b> The SDMS shall record an audit trail for each and every record created and modified, using version control.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.9<\/b> The SDMS shall provide proper systems for backing up, restoring, and archiving data for long-term use.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"25._Health_information_technology\">25. Health information technology<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-1\u2013a-4)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.1<\/b> The electronic health record (EHR) module should provide computerized provider order entry (CPOE) functionality for medication orders, laboratory orders, and diagnostic imaging, including making checks for potential drug-drug and drug-allergy interactions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-5)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-11\u2013a-12)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-15)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.2<\/b> The EHR module should allow authorized personnel to record, change, and access patient demographic data, including, but not limited to, race and ethnicity, patient's preferred language, birth sex, current sex, sexual orientation, gender identity, birth date, smoking status, alcohol use, family health history, psychological aspects, social aspects, and behavioral aspects.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-6\u2013a-8)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-10)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-14)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.3<\/b> The EHR module should allow authorized personnel to record, change, and access a patient's active problem list, medication list, medication allergy list, preferred drug list, and implantable device list, incorporating, where appropriate, at a minimum the SNOMED CT nomenclature standard.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-19)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.4<\/b> The EHR module should incorporate configurable, role-based clinical decision support tools capable of allowing authorized personnel to trigger electronic interventions based on liked reference information standardized to Health Level 7 (HL7) Version 3 implementation guides. The reference information should be sourced.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-13)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.5<\/b> The EHR module should be able to identify education resources specific to a patient's active problem and medication lists. The educational resources should be standardized to Health Level 7 (HL7) Version 3 implementation guides.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-1\u2013b-2; b-4\u2013b-5)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.6<\/b> The EHR module should allow authorized personnel to create, view, send, and receive transition of care or referral summaries in such a way that the summary is properly formatted, matched to the correct patient, and reconciled according to the standards and protocols outlined in 45 CFR Part 170.315 (b-1), (b-2), (b-4), and (b-5).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.7<\/b> The EHR module should allow authorized personnel to conduct electronic prescribing actions such as creating, changing, cancelling, and refilling prescriptions, incorporating at least the RxNorm and NCPDP SCRIPT standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-6)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.8<\/b> The EHR module should allow authorized personnel to configure, create, and store data exports, incorporating at least HL7 Version 3 implementation standards, as well as SNOMED CT and ICD-9 standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-7\u2013b-8)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.9<\/b> The EHR module should allow for the secure creation, sending, and receipt of restricted summary records, incorporating HL7 Version 3 implementation standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-9)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.10<\/b> The EHR module should allow authorized personnel to create, record, change, access, and receive care plan information, incorporating HL7 Version 3 implementation standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (c)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.11<\/b> The EHR module should provide a means to record, calculate, import, export, filter, and report on clinical quality measures according to the standards outlined in 45 CFR Part 170.315 (c).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.12<\/b> The EHR module shall provide security and access controls for protecting stored data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.13<\/b> The EHR module shall record an audit trail for each and every record created and modified, using version control.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.14<\/b> The EHR module shall either encrypt electronic health information on end-user devices after use of the technology on the device stops or prevent electronic health information from being stored on end-user devices after use of the technology on the device stops.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-8)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.15<\/b> The EHR module shall ensure that electronically exchanged health information has not been altered during the transfer process, using at least a hashing algorithm secured to SHA-2 or better.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-11)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.16<\/b> The EHR module should be capable of recording patient disclosures made for treatment, payment, and health care operations.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (e-1)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.17<\/b> The EHR module should provide a means for patients and their authorized representatives to view, download, and transmit their personal health information and activity history log from the EHR via an internet-based technology, using the standards outlined in 45 CFR Part 170.315 (e-1).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (e-2\u2013e-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.18<\/b> The EHR module should provide a means for authorized users to securely send messages to and receive messages from patients, at the same time allowing for the recording, accessing, and linking of information shared by the patient electronically (as well as directly).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (f)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.19<\/b> The EHR module should allow vital patient information as it relates to public health to be transmitted to immunization registries, cancer registries, and public health agencies, as well as be accessed after the fact. This includes, but is not limited to, immunization history, surveillance information, laboratory test results, cancer case information, case reports, antimicrobial reporting, and health care survey information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-3\u2013g-5)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.20<\/b> The EHR developer should use user-centered and accessibility-centered design processes for creating and testing the EHR's functionality. A quality management system should be used during these processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-6)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.21<\/b> The EHR module's use of clinical document architecture (CDA) should be demonstrated and verified for conformance to the standards identified in 45 CFR Part 170.315 (g-6).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-7\u2013g-9)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.22<\/b> The EHR module should include an application programming interface (API) that demonstrates the EHR's ability to uniquely identify a patient and corresponding ID\/token in a received records or data category request in order to accurately and securely meet the request for that patient's data. The API should be well documented.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173544\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.091 seconds\nReal time usage: 0.100 seconds\nPreprocessor visited node count: 377\/1000000\nPost\u2010expand include size: 77243\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 20.131 1 -total\n 12.96% 2.609 1 Template:LIMSpec\/Production_management\n 11.73% 2.361 1 Template:LIMSpec\/Environmental_data_management\n 11.17% 2.248 1 Template:LIMSpec\/Veterinary_data_management\n 11.10% 2.234 1 Template:LIMSpec\/Health_information_technology\n 10.88% 2.191 1 Template:LIMSpec\/Scientific_data_management\n 9.85% 1.984 1 Template:LIMSpec\/Public_health_data_management\n 9.80% 1.973 1 Template:LIMSpec\/Forensic_case_and_data_management\n 9.37% 1.887 1 Template:LIMSpec\/Agriculture_and_food_data_management\n 9.11% 1.833 1 Template:LIMSpec\/Statistical_trending_and_control_charts\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11203-0!canonical and timestamp 20221202173544 and revision id 47561. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#17._Production_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#17._Production_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","4a86c66dbb770905efc543883944afb7_images":[],"4a86c66dbb770905efc543883944afb7_timestamp":1670002544,"a831dc6b2450793264d359a92c01fa15_type":"article","a831dc6b2450793264d359a92c01fa15_title":"16. Investigation and quality management","a831dc6b2450793264d359a92c01fa15_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#16._Investigation_and_quality_management","a831dc6b2450793264d359a92c01fa15_plaintext":"\n\nLII:LIMSpec\/Maintaining Laboratory Workflow and OperationsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.\n\n7. Document and records management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n7 CFR Part 331 (throughout)\r\n\n9 CFR Part 121 (throughout)\r\n\n10 CFR Part 20 (throughout)\r\n\n21 CFR Part 7 (throughout)\r\n\n21 CFR Part 117 (throughout)\r\n\n21 CFR Part 58 (throughout)\r\n\n21 CFR Part 211 (throughout)\r\n\n21 CFR Part 212 (throughout)\r\n\n21 CFR Part 225 (throughout)\r\n\n21 CFR Part 226 (throughout)\r\n\n21 CFR Part 312 (throughout)\r\n\n21 CFR Part 606 (throughout)\r\n\n21 CFR Part 810 (throughout)\r\n\n21 CFR Part 812 (throughout)\r\n\n21 CFR Part 820 (throughout)\r\n\n29 CFR Part 1910.134 (throughout)\r\n\n29 CFR Part 1910.1030 (throughout)\r\n\n29 CFR Part 1910.1200 (throughout)\r\n\n29 CFR Part 1910.1450 (throughout)\r\n\n40 CFR Part 262.213\u201314\r\n\n42 CFR Part 73 (throughout)\r\n\n42 CFR Part 493.1200\r\n\n42 CFR Part 493.1232\r\n\n42 CFR Part 493.1239\r\n\n42 CFR Part 493.1251\r\n\n42 CFR Part 493.1291 (j)\r\n\n45 CFR Part 164 (throughout)\r\n\n61 FR 38806 (throughout)\r\n\nA2LA C211 4.3\r\n\nA2LA C223 4.13\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\nAAVLD Requirements for an AVMDL (throughout)\r\n\nABFT Accreditation Manual (throughout)\r\n\nASTM E1188-11 3.5.2\r\n\nASTM E1492-11 4.3.3.3 and 4.4.4\r\n\nASTM E1578-18 D-1-1\r\n\nBRC GSFS, Issue 8, 3.1.1\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nBRC GSFS, Issue 8, 5.6.1.1\r\n\nBRC GSFS, Issue 8, 5.6.2.2\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual (throughout)\r\n\nCJIS Security Policy (throughout)\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)\r\n\nEPA 815-R-05-004 (throughout)\r\n\nEPA ERLN Laboratory Requirements (throughout)\r\n\nEPA QA\/G-5 (throughout)\r\n\nE.U. Commission Directive 2003\/94\/EC (throughout)\r\n\nFDA Hazard Analysis Critical Control Point (throughout)\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\nIFS Food 7, Part 2 (throughout)\r\n\nIFS PACsecure 2, Part 2 (throughout)\r\n\nISO 15189:2012 4.3\r\n\nISO 15189:2012 5.5.3\r\n\nISO 15189:2012 5.9.3\r\n\nISO\/IEC 17025:2017 5.3\r\n\nISO\/IEC 17025:2017 5.5\r\n\nISO\/IEC 17025:2017 8.3.2\r\n\nISO\/TS 22002-1:2009 (throughout)\r\n\nISO\/TS 22002-4:2013 (throughout)\r\n\nISO\/TS 22002-6:2016 (throughout)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5 (throughout)\r\n\nOECD GLP Principles 8\r\n\nOSHA 1910.1200(b)(3)\r\n\nOSHA 1910.1450(e) and (h)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\nSQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nUSDA Data and Instrumentation for PDP (throughout)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\nWHO Technical Report Series, #961, Annex 13 (throughout)\r\n\nWHO Technical Report Series, #986, Annex 2 (throughout)\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\n\n\n\n7 CFR Part 331 (throughout)\r\n\n9 CFR Part 121 (throughout)\r\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 7 (throughout)\r\n\n21 CFR Part 58 (throughout)\r\n\n21 CFR Part 117 (throughout)\r\n\n21 CFR Part 211 (throughout)\r\n\n21 CFR Part 212 (throughout)\r\n\n21 CFR Part 225 (throughout)\r\n\n21 CFR Part 226 (throughout)\r\n\n21 CFR Part 312 (throughout)\r\n\n21 CFR Part 606 (throughout)\r\n\n21 CFR Part 810 (throughout)\r\n\n21 CFR Part 812 (throughout)\r\n\n21 CFR Part 820 (throughout)\r\n\n29 CFR Part 1910.134 (c)\r\n\n29 CFR Part 1910.1030 (throughout)\r\n\n29 CFR Part 1910.1200 (e)\r\n\n29 CFR Part 1910.1450 (throughout)\r\n\n40 CFR Part 262.214\r\n\n42 CFR Part 73 (throughout)\r\n\n42 CFR Part 93.300\u20135\r\n\n42 CFR Part 493.1200\r\n\n42 CFR Part 493.1232\r\n\n42 CFR Part 493.1239\r\n\n42 CFR Part 493.1251\r\n\n42 CFR Part 493.1291 (j)\r\n\n42 CFR Part 493.1773 (c\u2013d)\r\n\n45 CFR Part 160.310\r\n\n45 CFR Part 164 (throughout)\r\n\n61 FR 38806 (throughout)\r\n\nA2LA C211 (throughout)\r\n\nA2LA C223 (throughout)\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\nAAVLD Requirements for an AVMDL (throughout)\r\n\nACMG Technical Standards for Clinical Genetics Laboratories (throughout)\r\n\nAIHA-LAP Policies 2022 Appendix H5.8\r\n\nASTM E1188-11 3.5.2\r\n\nASTM E1492-11 4.3.3.3 and 4.4.4\r\n\nASTM E1578-18 D-1-2\r\n\nBRC GSFS, Issue 8, 3.1.2\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nBRC GSFS, Issue 8, 5.6.2.2\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual (throughout)\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)\r\n\nCJIS Security Policy (throughout)\r\n\nCLSI QMS22 (throughout)\r\n\nEPA 815-R-05-004 (throughout)\r\n\nEPA ERLN Laboratory Requirements (throughout)\r\n\nEPA QA\/G-5 (throughout)\r\n\nE.U. Commission Directive 2003\/94\/EC (throughout)\r\n\nFDA Hazard Analysis Critical Control Point (throughout)\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\nIFS Food 7, Part 2 (throughout)\r\n\nIFS PACsecure 2, Part 2 (throughout)\r\n\nISO 15189:2012 (throughout)\r\n\nISO\/IEC 17025:2017 (throughout)\r\n\nISO\/TS 22002-1:2009 (throughout)\r\n\nISO\/TS 22002-4:2013 (throughout)\r\n\nISO\/TS 22002-6:2016 (throughout)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5 (throughout)\r\n\nOECD GLP Principles 8\r\n\nOSHA 1910.1020 (throughout)\r\n\nOSHA 1910.1200(b)(3)\r\n\nOSHA 1910.1450(h)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\nSQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nUSDA Data and Instrumentation for PDP (throughout)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines (throughout)\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3\r\n\nUSDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\nWADA International Standard for Laboratories (ISL) (throughout)\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\r\n\nWHO Technical Report Series, #961, Annex 13 (throughout)\r\n\nWHO Technical Report Series, #986, Annex 2 (throughout)\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.2 The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\n\n\n\n21 CFR Part 1.1154 (c)\r\n\n21 CFR Part 820.40 (a)\r\n\n42 CFR Part 493.1251 (e)\r\n\nA2LA C211 4.3\r\n\nAAVLD Requirements for an AVMDL Sec. 4.3\r\n\nASTM E1578-18 D-1-3\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nEPA 815-R-05-004 Chap. III, Sec. 11\r\n\nEPA ERLN Laboratory Requirements 4.2.4.2\r\n\nEPA QA\/G-5 2.1.9\r\n\nISO 15189:2012 4.3\r\n\nISO 15189:2012 5.5.3\r\n\nISO 15189:2012 5.9.3\r\n\nISO\/IEC 17025:2017 7.5.2\r\n\nISO\/IEC 17025:2017 8.3.2\r\n\nUSDA Administrative Procedures for the PDP 5.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.5\n\n\n7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.\n\n\nASTM E1578-18 D-1-4\n\n7.4 The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1151\r\n\n21 CFR Part 1.1152 (e)\r\n\n21 CFR Part 106.91 (c)\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.315\r\n\n21 CFR Part 111.320\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.160\r\n\n21 CFR Part 212.20 (c)\r\n\n21 CFR Part 212.60 (c)\r\n\n21 CFR Part 226.58 (e)\r\n\n21 CFR Part 820.250 (b)\r\n\n42 CFR Part 493.43 (c)\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nASTM E1578-18 D-1-5\r\n\nBRC GSFS, Issue 8, 5.6.1.1\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.3\r\n\nCodex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\nCodex Alimentarius CXS 234-1999 (throughout)\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 5\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\nIFS Food 7, Part 2, 5.5.2\r\n\nIFS Food 7, Part 2, 5.6.2\r\n\nIFS PACsecure 2, Part 2, 5.5.2\r\n\nIFS PACsecure 2, Part 2, 5.6.2\r\n\nISO\/IEC 17025:2017 6.5\r\n\nISO\/IEC 17025:2017 7.2.1.3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)\r\n\nUSDA Administrative Procedures for the PDP 8.4\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1\r\n\nWHO Technical Report Series, #986, Annex 2, 15.14\n\n\n7.5 The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1151\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.320\r\n\n21 CFR Part 212.20 (c)\r\n\n21 CFR Part 212.70 (b)\r\n\nA2LA C211 5.4.5\r\n\nA2LA C223 5.4\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.4\r\n\nABFT Accreditation Manual Sec. G-12, -14, and -15\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C10\r\n\nACMG Technical Standards for Clinical Genetics Laboratories F7.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4\r\n\nCodex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\nCodex Alimentarius CXS 234-1999 (throughout)\r\n\nEPA QA\/G-5 2.2.4\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\nISO\/IEC 17025:2017 7.2.2.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\nUSDA Administrative Procedures for the PDP 8.4\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6\r\n\nWHO Technical Report Series, #961, Annex 13, 10.1\r\n\nWHO Technical Report Series, #986, Annex 2, 4.11\r\n\nWHO Technical Report Series, #986, Annex 2, 15.13\n\n\n7.6 The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\n\n\n\n7 CFR Part 331.10\r\n\n7 CFR Part 331.15\r\n\n9 CFR Part 2.32\r\n\n9 CFR Part 121.10 \r\n\n9 CFR Part 121.15 \r\n\n10 CFR Part 30.34 (j-3)\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 11.10 (i)\r\n\n21 CFR Part 58.29\r\n\n21 CFR Part 211.25\r\n\n21 CFR Part 225.10\r\n\n21 CFR Part 226.10\r\n\n21 CFR Part 226.40\r\n\n21 CFR Part 820.25\r\n\n29 CFR Part 1910.134 (c)\r\n\n29 CFR Part 1910.1030 (g-2)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n29 CFR Part 1910.1200 (h)\r\n\n29 CFR Part 1910.1450 (f)\r\n\n40 CFR Part 262.207\r\n\n40 CFR Part 262.210\u201312\r\n\n42 CFR Part 73.10\r\n\n42 CFR Part 73.15\r\n\n42 CFR Part 493.43 (c)\r\n\n42 CFR Part 493.1235\r\n\n42 CFR Part 493.1251\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 417.5\r\n\nA2LA C211 5.2\r\n\nA2LA C223 5.2\r\n\nA2LA C223 5.7\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\nAAVLD Requirements for an AVMDL Appendix 1\r\n\nABFT Accreditation Manual Sec. B\r\n\nACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.4\r\n\nAIHA-LAP Policies 2022 (throughout)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASTM E1578-18 C-3-5\r\n\nASTM E1578-18 D-1-6\r\n\nASTM E1578-18 E-1-6\r\n\nBRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nCAP Laboratory Accreditation Manual\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCLSI QMS22 (throughout)\r\n\nE.U. Annex 11-2\r\n\nE.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\nEPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 1\r\n\nEPA QA\/G-5 2.1.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.1\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.1\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nISO 15189:2012 4.1.2.1\r\n\nISO 15189:2012 5.1.6\r\n\nISO 15189:2012 5.1.9\r\n\nISO\/IEC 17025:2017 6.2.2\r\n\nISO\/IEC 17025:2017 6.2.3\r\n\nISO\/IEC 17025:2017 6.2.5\r\n\nISO\/IEC 17025:2017 6.2.6\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nOECD GLP Principles 1.1.2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\n\n\n7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n\n\nASTM E1578-18 D-1-7\n\n7.8 The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\n\n\nAAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5\r\nEPA ERLN Laboratory Requirements 4.10.6\n\n7.9 The system shall support the addition of accurate cross-references and page numbers to new documents.\n\n\nAAVLD Requirements for an AVMDL Sec. 4.3.4\n\n7.10 The system shall be capable of uniquely identifying documents created in and added to the system.\n\n\nAPHL 2019 LIS Project Management Guidebook\r\n\n\n7.11 The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\n\n\n\n8. Resource management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n9 CFR Part 2.32\r\n\n10 CFR Part 20.2103\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 110.10 (c)\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.10\r\n\n29 CFR Part 1910.120\r\n\n29 CFR Part 1910.134 (m)\r\n\n29 CFR Part 1910.1030 (h-1)\r\n\n29 CFR Part 1910.1450 (j)\r\n\n40 CFR Part 262.207\r\n\nA2LA C211 4.13.2.3\r\n\nA2LA C223 5.2\r\n\nA2LA C223 5.7\r\n\nACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nBRC GSFS, Issue 8, 7.3.1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.2.3\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nEPA QA\/G-5 2.1.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.1\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.1\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nNIST 800-53, Rev. 5, AT-3 and -4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOSHA 1910.1020 (throughout)\r\n\nOSHA 1910.1200(b)(3) and (h)\r\n\nOSHA 1910.1450 (throughout)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nUSDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\r\n\nWHO Technical Report Series, #996, Annex 5, 8.1\n\n\n8.1 The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\n\n\n\n21 CFR Part 820.198\r\n\n42 CFR Part 493.1233\r\n\nBRC GSFS, Issue 8, 3.10.1\u20132\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21\r\n\nIFS Food 7, Part 2, 5.8\r\n\nIFS PACsecure 2, Part 2, 5.8\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)\r\n\nWADA International Standard for Laboratories (ISL) 5.3.10\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\n\n\n8.2 The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.\n\n\n\n5 CFR Part 930.301\r\n\n7 CFR Part 331.15\r\n\n9 CFR Part 121.15\r\n\n21 CFR Part 120.12\r\n\nhttps:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123 21 CFR Part 123.10]\r\n\n21 CFR Part 211.25\r\n\n29 CFR Part 1910.1450 (f)\r\n\n42 CFR Part 73.15\r\n\nA2LA C223 5.2\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3\r\n\nASTM E1578-18 E-1-1\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nCJIS Security Policy 5.2.1\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nNIST 800-53, Rev. 5, AT-2 and AT-3\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Sampling Procedures for PDP 6.1.2\u20133\r\n\nWHO Technical Report Series, #986, Annex 2, 10\n\n\n8.3 The system shall allow training sessions and reviews to be scheduled for personnel.\n\n\n\n5 CFR Part 930.301\r\n\n29 CFR Part 1910.1450 (f)\r\n\nABFT Accreditation Manual Sec. B\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7\r\n\nASTM E1578-18 E-1-2\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.4 The system should provide access to relevant training materials to personnel attending training sessions.\n\n\n\n5 CFR Part 930.301\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 110.10 (c)\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.10\r\n\n29 CFR Part 1910.1450 (f)\r\n\n40 CFR Part 262.207\r\n\nA2LA C223 5.2\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5\r\n\nASTM E1578-18 E-1-3\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.2.3\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nEPA QA\/G-5 2.1.8\r\n\nE.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nISO 15189:2012 5.1.9\r\n\nNIST 800-53, Rev. 5, AT-2\u2013AT-4\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e\r\n\nUSDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (e)\r\n\nWHO Technical Report Series, #986, Annex 2, 9.4\r\n\nWHO Technical Report Series, #986, Annex 2, 10\n\n\n8.5 The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\n\n\n\nABFT Accreditation Manual Sec. B\r\n\nASTM E1578-18 E-1-4\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\n\n\n8.6 The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\n\n\n\nASTM E1578-18 E-1-5\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nNIST 800-53, Rev. 5, AT-2 and AT-3\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.7 The system should be able to produce a training matrix of personnel.\n\n\n\n7 CFR Part 331.15\r\n\n9 CFR Part 121.10 \r\n\n9 CFR Part 121.15 \r\n\n21 CFR Part 11.10 (i)\r\n\n21 CFR Part 58.29\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 211.25\r\n\n21 CFR Part 225.10\r\n\n21 CFR Part 226.10\r\n\n21 CFR Part 226.40\r\n\n21 CFR Part 820.25\r\n\n29 CFR Part 1910.1030 (g-2)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n29 CFR Part 1910.1200 (h)\r\n\n29 CFR Part 1910.1450 (e)\r\n\n42 CFR Part 73.10\r\n\n42 CFR Part 73.15\r\n\n42 CFR Part 493.43 (c)\r\n\n42 CFR Part 493.1235\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nA2LA C223 5.2\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\nAAVLD Requirements for an AVMDL Appendix 1\r\n\nABFT Accreditation Manual Sec. B\r\n\nAIHA-LAP Policies 2022 (various parts)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASTM E1578-18 C-3-5\r\n\nASTM E1578-18 D-1-6\r\n\nASTM E1578-18 E-1-6\r\n\nBRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nE.U. Annex 11-2\r\n\nEPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 1\r\n\nEPA QA\/G-5 2.1.8\r\n\nISO 15189:2012 4.1.2.1\r\n\nISO 15189:2012 5.1.6\r\n\nISO 15189:2012 5.1.9\r\n\nISO\/IEC 17025:2017 6.2.2\r\n\nISO\/IEC 17025:2017 6.2.3\r\n\nISO\/IEC 17025:2017 6.2.5\r\n\nISO\/IEC 17025:2017 6.2.6\r\n\nOECD GLP Principles 1.1.2\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\n\n\n8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n\n\n\n9. Compliance management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17 \r\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1251 (d)\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nASTM E1578-18 C-4-7\r\n\nASTM E1578-18 E-2-1\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Annex 11-9\r\n\nE.U. Annex 11-14\r\n\nOECD GLP Principles 8.3.5\r\n\nUSDA Data and Instrumentation for PDP 8.1.3\n\n\n9.1 The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-2\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCJIS Security Policy Appendix G.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Annex 11-9\r\n\nE.U. Annex 11-12.4\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nNIST 800-53, Rev. 5, AC-2(4) and AC-6(9)\r\n\nNIST 800-53, Rev. 5, AU-2 and AU-3\r\n\nNIST 800-53, Rev. 5, CM-5(1)\r\n\nOECD GLP Principles 8.3.5\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n9.2 The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1274\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-3\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCLSI QMS22 2.2.3.2\r\n\nCLSI QMS22 2.4.3\r\n\nE.U. Annex 11-12.4\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nNIST 800-53, Rev. 5, AU-3 and AU-8\r\n\nOECD GLP Principles 8.3.5\r\n\nUSDA Data and Instrumentation for PDP 8.1.4\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.3 The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-4\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nICH GCP 4.9.0 and 4.9.3\r\n\nNIST 800-53, Rev. 5, AU-3\r\n\nOECD GLP Principles 8.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.4 The system's audit trail shall document the previous and current value of a modified field.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1251 (d)\r\n\n45 CFR Part 164.310\r\n\nASTM E1578-18 E-2-5\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nE.U. Annex 11-14\r\n\nOECD GLP Principles 8.3.5\n\n\n9.5 The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\n\n\n21 CFR Part 11.70\r\nE.U. Annex 11-14\n\n9.6 The system shall prevent a user from copying and pasting the electronic signature of another user.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 58.130 (e)\r\n\n42 CFR Part 493.1274 (d)\r\n\nE.U. Annex 11-9\r\n\nNIST 800-53, Rev. 5, AU-6 and AU-12\r\n\nOECD GLP Principles 8.3.5\n\n\n9.7 The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\n\n\n\n10. Instrument and equipment management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-3-1\n\n10.1 The system should provide a means for tracking usage of laboratory equipment and instruments.\n\n\nASTM E1578-18 E-3-2\n\n10.2 The system shall provide a means for planning the use of and reserving equipment and instruments.\n\n\nASTM E1578-18 E-3-3\n\n10.3 The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\n\n\nASTM E1578-18 E-3-4\n\n10.4 The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\n\n\nASTM E1578-18 E-3-5\n\n10.5 The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\n\n\nASTM E1578-18 E-3-6\n\n10.6 The system shall be able to group instruments together in specific ways, including by type and laboratory location.\n\n\n\n21 CFR Part 110.40 (f)\r\n\n21 CFR Part 211.67\u201368\r\n\n21 CFR Part 211.160 (b-4)\r\n\n21 CFR Part 212.30 (b)\r\n\n21 CFR Part 212.60 (e)\r\n\n21 CFR Part 225.30 (b-4)\r\n\n21 CFR Part 606.60\r\n\n21 CFR Part 820.70 (g)\r\n\n21 CFR Part 820.72\r\n\n42 CFR Part 493.1252 (b-3)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.5.2\r\n\nA2LA C223 5.5\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5\r\n\nABFT Accreditation Manual Sec. E-20\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1\r\n\nAIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\nASTM E1578-18 E-3-7\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.6.1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nISO 15189:2012 5.3.1.4\r\n\nISO\/IEC 17025:2017 6.4.7\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nISO\/TS 22002-4:2013, 4.7.1\r\n\nISO\/TS 22002-6:2016, 4.7\r\n\nNIST 800-53, Rev. 5, MA-2 and MA-2(2)\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Data and Instrumentation for PDP 5.2\r\n\nUSDA Data and Instrumentation for PDP 6\r\n\nWADA International Standard for Laboratories (ISL) 5.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 13.5\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\n\n\n\n21 CFR Part 225.30 (b-4)\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5.9\r\n\nASTM E1578-18 E-3-8\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.8 The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\n\n\n\n21 CFR Part 211.160 (b-4)\r\n\nA2LA C211 5.5.7\r\n\nA2LA C223 5.6\r\n\nABFT Accreditation Manual Sec. E-21\r\n\nASTM E1578-18 E-3-9\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nCLSI QMS22 2.1.2.1\r\n\nIFS Food 7, Part 2, 5.4.3\r\n\nIFS PACsecure 2, Part 2, 5.4.3\r\n\nISO 15189:2012 5.3.1.5\r\n\nISO\/IEC 17025:2017 6.4.9\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)\r\n\nWHO Technical Report Series, #986, Annex 2, 13.10\n\n\n10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.\n\n\n\n21 CFR Part 111.117\r\n\n21 CFR Part 820.72 (b-2)\r\n\nASTM E1578-18 E-3-10\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nNIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\n\n\n\n21 CFR Part 820.72 (b-1)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.6.2.1\r\n\nA2LA C223 5.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.6.1\u20132\r\n\nAIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nISO\/IEC 17025:2017 6.5\r\n\nISO\/TS 22002-4:2013, 4.7.1\r\n\nISO\/TS 22002-6:2016, 4.7\r\n\nOECD GLP Principles 4.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.2\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)\r\n\nUSDA Data and Instrumentation for PDP 6.1\n\n\n10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\n\n\nASTM E1578-18 E-3-11\n\n10.12 The system shall support the use of predefined intervals when calculating instrument event dates.\n\n\n\n21 CFR Part 110.40 (f)\r\n\n21 CFR Part 211.105 (b)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.5.4 and 5.5.5\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5.4\u20135\r\n\nASTM E1578-18 E-3-12\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1\r\n\nIFS Food 7, Part 2, 5.4.1\r\n\nIFS PACsecure 2, Part 2, 5.4.1\r\n\nISO 15189:2012 5.3.1.7\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nISO\/IEC 17025:2017 6.4.13\r\n\nNIST 800-53, Rev. 5, CM-8\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\nUSDA Administrative Procedures for the PDP 7.2\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4\r\n\nWHO Technical Report Series, #961, Annex 13, 6.1\n\n\n10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\n\n\nASTM E1578-18 E-3-13\n\n10.14 The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\n\n\n\n10 CFR Part 20.2103\r\n\n21 CFR Part 58.63\r\n\n21 CFR Part 111.117\r\n\n21 CFR Part 211.67\u201368\r\n\n21 CFR Part 211.160 (b-4)\r\n\n21 CFR Part 211.182\r\n\n21 CFR Part 211.194 (d)\r\n\n21 CFR Part 212.30 (b)\r\n\n21 CFR Part 212.60 (e)\r\n\n21 CFR Part 820.70 (g)\r\n\n21 CFR Part 820.72\r\n\n42 CFR Part 493.1254\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 4.13.2.1\r\n\nA2LA C211 5.5.2\r\n\nA2LA C211 5.10.4\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5\r\n\nABFT Accreditation Manual Sec. E-20 and -23\r\n\nABFT Accreditation Manual Sec. F-1 and I-1\r\n\nAIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\nASTM E1578-18 E-3-14\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.2.1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nISO 15189:2012 5.3.1.4\r\n\nISO\/IEC 17025:2017 6.4.4\r\n\nNIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 4.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Data and Instrumentation for PDP 5.4\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c\r\n\nWADA International Standard for Laboratories (ISL) 5.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 15.46\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.15 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\n\n\n\n11. Batch and lot management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 58.105 (a)\r\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nASTM E1578-18 E-4-1\r\n\nEPA ERLN Laboratory Requirements 3.3\r\n\nEPA ERLN Laboratory Requirements 4.10.1\r\n\nOECD GLP Principles 6.2\n\n\n11.1 The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\n\n\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nASTM E1578-18 E-4-2\r\n\nEPA ERLN Laboratory Requirements 4.10.1\n\n\n11.2 The system shall maintain the links between component parts of a batch and track the batch throughout the system.\n\n\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 820.65\r\n\nASTM E1578-18 E-4-3\n\n\n11.3 The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\n\n\nASTM E1578-18 E-4-4\n\n11.4 The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\n\n\nE.U. Annex 11-15\n\n11.5 The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\n\n\n\n12. Scheduled event management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 129.80 (g)\r\nASTM E1578-18 E-5-1\r\nUSDA Sampling Procedures for PDP 5.6\u20137\n\n12.1 The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.\n\n\n21 CFR Part 212.61 (a)\r\n21 CFR Part 211.166 (b)\r\nASTM E1578-18 E-5-2\n\n12.2 The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.\n\n\nASTM E1578-18 E-5-3\n\n12.3 The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\n\n\nASTM E1578-18 E-5-4\n\n12.4 The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).\n\n\nASTM E1578-18 E-5-5\n\n12.5 The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\n\n\n\n13. Instrument data capture and control \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-6-1\n\n13.1 The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\n\n\nASTM E1578-18 E-6-2\n\n13.2 The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\n\n\nASTM E1578-18 E-6-3\n\n13.3 The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\n\n\nASTM E1578-18 E-6-4\n\n13.4 The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\n\n\nASTM E1578-18 E-6-5\n\n13.5 The system should be able to accept the results uploaded from an interfaced instrument.\n\n\nASTM E1578-18 E-6-6\n\n13.6 The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\n\n\nASTM E1578-18 E-6-7\n\n13.7 The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\n\n\nASTM E1578-18 E-6-8\n\n13.8 The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\n\n\n\n14. Standard and reagent management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 58.83\r\n\n29 CFR Part 1910.1200 (g)\r\n\n29 CFR Part 1910.1450 (h)\r\n\n42 CFR Part 493.1252 (c)\r\n\nABFT Accreditation Manual Sec. E-17\r\n\nASTM E1578-18 E-7-1\r\n\nISO 15189:2012 5.3.2.4\u20135\r\n\nOECD GLP Principles 4.4\n\n\n14.1 The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\n\n\n\n7 CFR Part 331.3\r\n\n9 CFR Part 121.3\r\n\n21 CFR Part 312.58 (b)\r\n\n42 CFR Part 73.3\u20134 (c)\r\n\nASTM E1578-18 E-7-2\r\n\nEPA ERLN Laboratory Requirements 4.1.12\r\n\nISO 15189:2012 5.3.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 12.20\n\n\n14.2 The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\n\n\nASTM E1578-18 E-7-3\r\nISO 15189:2012 5.3.2.4\n\n14.3 The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\n\n\nASTM E1578-18 E-7-4\r\nISO 15189:2012 5.3.2.4\n\n14.4 The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\n\n\nASTM E1578-18 E-7-5\r\nISO 15189:2012 5.3.2.4\n\n14.5 The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\n\n\n\n15. Inventory management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-8-1\r\nCAP Laboratory Accreditation Manual\r\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples and specimens.\n\n\n\n21 CFR Part 212.60 (d)\r\n\nASTM E1578-18 E-8-2\r\n\nCLSI QMS22 2.1.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.2 The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\n\n\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.101\r\n\n21 CFR Part 212.60 (d)\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 606.120 (b)\r\n\n29 CFR Part 1910.1030 (g)\r\n\n29 CFR Part 1910.1096 (e-6)\r\n\n29 CFR Part 1910.1200 (f-6) and (f-10)\r\n\n40 CFR Part 262.206\r\n\nASTM E1578-18 E-8-3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOSHA 1910.1200(b)(3) and (f)\r\n\nOSHA 1910.1450(h)\r\n\nWHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41\r\n\nWHO Technical Report Series, #986, Annex 2, 15.10\u201312\n\n\n15.3 The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\n\n\n\n21 CFR Part 117.420\r\n\n21 CFR Part 212.40 (c)\r\n\n21 CFR Part 820.50\r\n\nA2LA C211 4.6\r\n\nASTM E1578-18 E-8-4\r\n\nBRC GSFS, Issue 8, 3.5.1.4\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5\r\n\nIFS Food 7, Part 2, 4.4.1\r\n\nIFS PACsecure 2, Part 2, 4.4.1\r\n\nISO\/TS 22002-1:2009, 9.2\r\n\nISO\/TS 22002-4:2013, 4.6.2\r\n\nISO\/TS 22002-6:2016, 4.6.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.4.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)\r\n\nUSDA Administrative Procedures for the PDP 7.1\r\n\nWHO Technical Report Series, #961, Annex 13, 7.1 and 7.3\r\n\nWHO Technical Report Series, #986, Annex 2, 14.8\n\n\n15.4 The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\n\n\n\n21 CFR Part 211.196\r\n\n21 CFR Part 212.90\r\n\n21 CFR Part 225.110\r\n\n21 CFR Part 606.165\r\n\n29 CFR Part 1910.1450 Appendix A (I)\r\n\nA2LA C211 4.6\r\n\nASTM E1578-18 E-8-5\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5\n\n\n15.5 The system should provide a means for accurately recording the receipt, approval, distribution, and disposal of materials.\n\n\n\n21 CFR Part 211.82 (b)\r\n\n21 CFR Part 211.84 (a)\r\n\n21 CFR Part 211.89\r\n\n21 CFR Part 211.110 (d)\r\n\n21 CFR Part 211.142 (a)\r\n\n21 CFR Part 212.40 (c)\r\n\nASTM E1578-18 E-8-6\r\n\nWHO Technical Report Series, #986, Annex 2, 12.18\n\n\n15.6 The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\n\n\n\n21 CFR Part 211.89\r\n\n21 CFR Part 211.110 (d)\r\n\n42 CFR Part 493.1252 (d)\r\n\nASTM E1578-18 E-8-7\n\n\n15.7 The system should allow authorized personnel to retire faulty or poor quality materials from use.\n\n\n\n21 CFR Part 211.89\r\nASTM E1578-18 E-8-8\n\n\n15.8 The system shall clearly designate a standard or reagent as being disposed or consumed.\n\n\n\n16. Investigation and quality management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 312.62 (b)\r\n21 CFR Part 812.140 (a-3)\n\n16.1 The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\n\n\n\n21 CFR Part 312.57 (a)\r\n\n21 CFR Part 312.62 (a)\r\n\n21 CFR Part 606.165\r\n\n21 CFR Part 812.140 (a-2) and (b-2)\n\n\n16.2 The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\n\n\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 58.81 (a)\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.111\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 211.194\r\n\n21 CFR Part 606.171\r\n\n42 CFR Part 493.1253 (b-2)\r\n\nA2LA C211 5.4\r\n\nABFT Accreditation Manual C-16\r\n\nABFT Accreditation Manual F-2\r\n\nABFT Accreditation Manual J-3\r\n\nASTM E1578-18 E-9-1\r\n\nBRC GSFS, Issue 8, 5.6.2.3\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nCLSI QMS22 2.2.2.2\r\n\nEPA ERLN Laboratory Requirements 3.3\r\n\nEPA QA\/G-5 2.2.4\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\nISO\/IEC 17025:2017 7.2.1.7\r\n\nISO\/IEC 17025:2017 7.2.2.1\r\n\nISO\/IEC 17025:2017 7.10.2\r\n\nISO\/IEC 17025:2017 8.7.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 7.3\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)\r\n\nUSDA Administrative Procedures for the PDP 8.2.2\r\n\nWADA International Standard for Laboratories (ISL) 5.3.6\r\n\nWHO Technical Report Series, #986, Annex 2, 16.3\n\n\n16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\n\n\n42 CFR Part 493.1282\r\nASTM E1578-18 E-9-2\r\nE.U. Commission Reg. No. 2073\/2005 Article 9\n\n16.4 The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\n\n\n\n21 CFR Part 606.100 (c)\r\n\n42 CFR Part 493.1282\r\n\nASTM E1578-18 E-9-3\r\n\nCLSI QMS22 2.1.2.1\r\n\nCLSI QMS22 2.2.2.3\r\n\nEPA QA\/G-5 2.2.10\r\n\nWHO Technical Report Series, #986, Annex 2, 17.12\r\n\nWHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.5 The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\n\n\n\n10 CFR Part 30.34 (g)\r\n\n21 CFR Part 112.147\r\n\n21 CFR Part 225.58 (d)\r\n\n21 CFR Part 225.158\r\n\n21 CFR Part 606.100 (c)\r\n\n21 CFR Part 820.100\r\n\n42 CFR Part 493.1282\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nA2LA C211 4.9 and 4.11\r\n\nASTM E1578-18 E-9-4\r\n\nBRC GSFS, Issue 8, 3.4.3\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCLSI QMS22 2.6.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nFDA Hazard Analysis Critical Control Point Principle 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5, IR-5\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\nWADA International Standard for Laboratories (ISL) 5.3.9\r\n\nWHO Technical Report Series, #961, Annex 13, 11.1\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\r\n\nWHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\n\n\n\n21 CFR Part 225.58 (d)\r\n\n21 CFR Part 225.158\r\n\n42 CFR Part 493.1282\r\n\n42 CFR Part 493.1289\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nA2LA C211 4.8 and 4.11\r\n\nASTM E1578-18 E-9-5\r\n\nBRC GSFS, Issue 8, 3.4.3\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.3.4\r\n\nCJIS Security Policy Appendix G.7\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nFDA Hazard Analysis Critical Control Point Principle 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5, AU-6(1)\r\n\nNIST 800-53, Rev. 5, IR-4(1) and IR-5\r\n\nNIST 800-53, Rev. 5, SI-2 and SI-4\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\n\n\n16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\n\n\nASTM E1578-18 E-9-6\n\n16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\n\n\n9 CFR Part 2.35\n\n16.9 The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#16._Investigation_and_quality_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#16._Investigation_and_quality_management<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 2 May 2022, at 22:08.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2,552 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","a831dc6b2450793264d359a92c01fa15_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Maintaining_Laboratory_Workflow_and_Operations rootpage-LII_LIMSpec_Maintaining_Laboratory_Workflow_and_Operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Maintaining Laboratory Workflow and Operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"7._Document_and_records_management\">7. Document and records management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/part-20\" target=\"_blank\">10 CFR Part 20 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.213\u201314<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(e) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.1<\/b> The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.214<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.300\" target=\"_blank\">42 CFR Part 93.300\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1773\" target=\"_blank\">42 CFR Part 493.1773 (c\u2013d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/160.310\" target=\"_blank\">45 CFR Part 160.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 Appendix H5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.2<\/b> The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.3<\/b> The system shall be able to clearly provide the most current version of a document and archive prior versions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.4<\/b> The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.91 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.14<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.5<\/b> The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-12, -14, and -15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.13<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.6<\/b> The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.10\" target=\"_blank\">7 CFR Part 331.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (j-3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.210\" target=\"_blank\">40 CFR Part 262.210\u201312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.7<\/b> The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.8<\/b> The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.9<\/b> The system shall support the addition of accurate cross-references and page numbers to new documents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.10<\/b> The system shall be capable of uniquely identifying documents created in and added to the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>7.11<\/b> The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"8._Resource_management\">8. Resource management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (m)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-3 and -4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.1<\/b> The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.198\" target=\"_blank\">21 CFR Part 820.198<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1233\" target=\"_blank\">42 CFR Part 493.1233<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.10.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.2<\/b> The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123<\/a> 21 CFR Part 123.10]<br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.3<\/b> The system shall allow training sessions and reviews to be scheduled for personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.4<\/b> The system should provide access to relevant training materials to personnel attending training sessions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2\u2013AT-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.5<\/b> The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.6<\/b> The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.7<\/b> The system should be able to produce a training matrix of personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (various parts)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.8<\/b> The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"9._Compliance_management\">9. Compliance management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.1<\/b> The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-2 and AU-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.2<\/b> The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3 and AU-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.3<\/b> The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.4<\/b> The system's audit trail shall document the previous and current value of a modified field.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.5<\/b> The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>9.6<\/b> The system shall prevent a user from copying and pasting the electronic signature of another user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6 and AU-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.7<\/b> The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"10._Instrument_and_equipment_management\">10. Instrument and equipment management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.1<\/b> The system should provide a means for tracking usage of laboratory equipment and instruments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.2<\/b> The system shall provide a means for planning the use of and reserving equipment and instruments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.3<\/b> The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.4<\/b> The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.5<\/b> The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.6<\/b> The system shall be able to group instruments together in specific ways, including by type and laboratory location.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.60\" target=\"_blank\">21 CFR Part 606.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (b-3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2 and MA-2(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.7<\/b> The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.8<\/b> The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.9<\/b> The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.10<\/b> The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.6.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.11<\/b> The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.12<\/b> The system shall support the use of predefined intervals when calculating instrument event dates.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.4 and 5.5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.13<\/b> The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-13<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.14<\/b> The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.63\" target=\"_blank\">21 CFR Part 58.63<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.182\" target=\"_blank\">21 CFR Part 211.182<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1254\" target=\"_blank\">42 CFR Part 493.1254<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20 and -23<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. F-1 and I-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.46<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.15<\/b> The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"11._Batch_and_lot_management\">11. Batch and lot management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.1<\/b> The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.2<\/b> The system shall maintain the links between component parts of a batch and track the batch throughout the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.65\" target=\"_blank\">21 CFR Part 820.65<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.3<\/b> The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>11.4<\/b> The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-15<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>11.5<\/b> The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"12._Scheduled_event_management\">12. Scheduled event management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.6\u20137<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.1<\/b> The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.2<\/b> The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.3<\/b> The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.4<\/b> The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.5<\/b> The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"13._Instrument_data_capture_and_control\">13. Instrument data capture and control<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.1<\/b> The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.2<\/b> The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.3<\/b> The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.4<\/b> The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.5<\/b> The system should be able to accept the results uploaded from an interfaced instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.6<\/b> The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.7<\/b> The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.8<\/b> The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"14._Standard_and_reagent_management\">14. Standard and reagent management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.83\" target=\"_blank\">21 CFR Part 58.83<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>14.1<\/b> The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.3\" target=\"_blank\">7 CFR Part 331.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.3\" target=\"_blank\">9 CFR Part 121.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.3\" target=\"_blank\">42 CFR Part 73.3\u20134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.20<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>14.2<\/b> The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.3<\/b> The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.4<\/b> The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.5<\/b> The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"15._Inventory_management\">15. Inventory management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>15.1<\/b> The system should be capable of accurately tracking the specific quantities of received and consumed test samples and specimens.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.2<\/b> The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (f-6) and (f-10)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.206\" target=\"_blank\">40 CFR Part 262.206<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.10\u201312<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.3<\/b> The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.50\" target=\"_blank\">21 CFR Part 820.50<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.4<\/b> The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.196\" target=\"_blank\">21 CFR Part 211.196<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.90\" target=\"_blank\">21 CFR Part 212.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 Appendix A (I)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.5<\/b> The system should provide a means for accurately recording the receipt, approval, distribution, and disposal of materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.82\" target=\"_blank\">21 CFR Part 211.82 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.142\" target=\"_blank\">21 CFR Part 211.142 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.6<\/b> The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.7<\/b> The system should allow authorized personnel to retire faulty or poor quality materials from use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.8<\/b> The system shall clearly designate a standard or reagent as being disposed or consumed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"16._Investigation_and_quality_management\">16. Investigation and quality management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.1<\/b> The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-2) and (b-2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.2<\/b> The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.81\" target=\"_blank\">21 CFR Part 58.81 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.171\" target=\"_blank\">21 CFR Part 606.171<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1253\" target=\"_blank\">42 CFR Part 493.1253 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual F-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual J-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.3<\/b> The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.4<\/b> The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.5<\/b> The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.147<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.100\" target=\"_blank\">21 CFR Part 820.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.9 and 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 11.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.6<\/b> The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1289\" target=\"_blank\">42 CFR Part 493.1289<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.8 and 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-4(1) and IR-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2 and SI-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.7<\/b> The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.8<\/b> The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.9<\/b> The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173541\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.104 seconds\nReal time usage: 0.111 seconds\nPreprocessor visited node count: 1035\/1000000\nPost\u2010expand include size: 141529\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 20.237 1 -total\n 11.99% 2.426 1 Template:LIMSpec\/Document_management\n 10.55% 2.135 1 Template:LIMSpec\/Resource_management\n 9.87% 1.998 1 Template:LIMSpec\/Instrument_and_equipment_management\n 9.68% 1.958 1 Template:LIMSpec\/Compliance_management\n 9.13% 1.848 1 Template:LIMSpec\/Batch_and_lot_management\n 9.07% 1.836 1 Template:LIMSpec\/Investigation_and_quality_management\n 8.97% 1.815 1 Template:LIMSpec\/Inventory_management\n 8.81% 1.782 1 Template:LIMSpec\/Scheduled_event_management\n 8.72% 1.764 1 Template:LIMSpec\/Instrument_data_capture_and_control\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11181-0!canonical and timestamp 20221202173541 and revision id 47569. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#16._Investigation_and_quality_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#16._Investigation_and_quality_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","a831dc6b2450793264d359a92c01fa15_images":[],"a831dc6b2450793264d359a92c01fa15_timestamp":1670002543,"2d51a618475d6fdd30e9db36ce3c6512_type":"article","2d51a618475d6fdd30e9db36ce3c6512_title":"15. Inventory management","2d51a618475d6fdd30e9db36ce3c6512_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#15._Inventory_management","2d51a618475d6fdd30e9db36ce3c6512_plaintext":"\n\nLII:LIMSpec\/Maintaining Laboratory Workflow and OperationsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.\n\n7. Document and records management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n7 CFR Part 331 (throughout)\r\n\n9 CFR Part 121 (throughout)\r\n\n10 CFR Part 20 (throughout)\r\n\n21 CFR Part 7 (throughout)\r\n\n21 CFR Part 117 (throughout)\r\n\n21 CFR Part 58 (throughout)\r\n\n21 CFR Part 211 (throughout)\r\n\n21 CFR Part 212 (throughout)\r\n\n21 CFR Part 225 (throughout)\r\n\n21 CFR Part 226 (throughout)\r\n\n21 CFR Part 312 (throughout)\r\n\n21 CFR Part 606 (throughout)\r\n\n21 CFR Part 810 (throughout)\r\n\n21 CFR Part 812 (throughout)\r\n\n21 CFR Part 820 (throughout)\r\n\n29 CFR Part 1910.134 (throughout)\r\n\n29 CFR Part 1910.1030 (throughout)\r\n\n29 CFR Part 1910.1200 (throughout)\r\n\n29 CFR Part 1910.1450 (throughout)\r\n\n40 CFR Part 262.213\u201314\r\n\n42 CFR Part 73 (throughout)\r\n\n42 CFR Part 493.1200\r\n\n42 CFR Part 493.1232\r\n\n42 CFR Part 493.1239\r\n\n42 CFR Part 493.1251\r\n\n42 CFR Part 493.1291 (j)\r\n\n45 CFR Part 164 (throughout)\r\n\n61 FR 38806 (throughout)\r\n\nA2LA C211 4.3\r\n\nA2LA C223 4.13\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\nAAVLD Requirements for an AVMDL (throughout)\r\n\nABFT Accreditation Manual (throughout)\r\n\nASTM E1188-11 3.5.2\r\n\nASTM E1492-11 4.3.3.3 and 4.4.4\r\n\nASTM E1578-18 D-1-1\r\n\nBRC GSFS, Issue 8, 3.1.1\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nBRC GSFS, Issue 8, 5.6.1.1\r\n\nBRC GSFS, Issue 8, 5.6.2.2\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual (throughout)\r\n\nCJIS Security Policy (throughout)\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)\r\n\nEPA 815-R-05-004 (throughout)\r\n\nEPA ERLN Laboratory Requirements (throughout)\r\n\nEPA QA\/G-5 (throughout)\r\n\nE.U. Commission Directive 2003\/94\/EC (throughout)\r\n\nFDA Hazard Analysis Critical Control Point (throughout)\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\nIFS Food 7, Part 2 (throughout)\r\n\nIFS PACsecure 2, Part 2 (throughout)\r\n\nISO 15189:2012 4.3\r\n\nISO 15189:2012 5.5.3\r\n\nISO 15189:2012 5.9.3\r\n\nISO\/IEC 17025:2017 5.3\r\n\nISO\/IEC 17025:2017 5.5\r\n\nISO\/IEC 17025:2017 8.3.2\r\n\nISO\/TS 22002-1:2009 (throughout)\r\n\nISO\/TS 22002-4:2013 (throughout)\r\n\nISO\/TS 22002-6:2016 (throughout)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5 (throughout)\r\n\nOECD GLP Principles 8\r\n\nOSHA 1910.1200(b)(3)\r\n\nOSHA 1910.1450(e) and (h)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\nSQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nUSDA Data and Instrumentation for PDP (throughout)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\nWHO Technical Report Series, #961, Annex 13 (throughout)\r\n\nWHO Technical Report Series, #986, Annex 2 (throughout)\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\n\n\n\n7 CFR Part 331 (throughout)\r\n\n9 CFR Part 121 (throughout)\r\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 7 (throughout)\r\n\n21 CFR Part 58 (throughout)\r\n\n21 CFR Part 117 (throughout)\r\n\n21 CFR Part 211 (throughout)\r\n\n21 CFR Part 212 (throughout)\r\n\n21 CFR Part 225 (throughout)\r\n\n21 CFR Part 226 (throughout)\r\n\n21 CFR Part 312 (throughout)\r\n\n21 CFR Part 606 (throughout)\r\n\n21 CFR Part 810 (throughout)\r\n\n21 CFR Part 812 (throughout)\r\n\n21 CFR Part 820 (throughout)\r\n\n29 CFR Part 1910.134 (c)\r\n\n29 CFR Part 1910.1030 (throughout)\r\n\n29 CFR Part 1910.1200 (e)\r\n\n29 CFR Part 1910.1450 (throughout)\r\n\n40 CFR Part 262.214\r\n\n42 CFR Part 73 (throughout)\r\n\n42 CFR Part 93.300\u20135\r\n\n42 CFR Part 493.1200\r\n\n42 CFR Part 493.1232\r\n\n42 CFR Part 493.1239\r\n\n42 CFR Part 493.1251\r\n\n42 CFR Part 493.1291 (j)\r\n\n42 CFR Part 493.1773 (c\u2013d)\r\n\n45 CFR Part 160.310\r\n\n45 CFR Part 164 (throughout)\r\n\n61 FR 38806 (throughout)\r\n\nA2LA C211 (throughout)\r\n\nA2LA C223 (throughout)\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\nAAVLD Requirements for an AVMDL (throughout)\r\n\nACMG Technical Standards for Clinical Genetics Laboratories (throughout)\r\n\nAIHA-LAP Policies 2022 Appendix H5.8\r\n\nASTM E1188-11 3.5.2\r\n\nASTM E1492-11 4.3.3.3 and 4.4.4\r\n\nASTM E1578-18 D-1-2\r\n\nBRC GSFS, Issue 8, 3.1.2\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nBRC GSFS, Issue 8, 5.6.2.2\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual (throughout)\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)\r\n\nCJIS Security Policy (throughout)\r\n\nCLSI QMS22 (throughout)\r\n\nEPA 815-R-05-004 (throughout)\r\n\nEPA ERLN Laboratory Requirements (throughout)\r\n\nEPA QA\/G-5 (throughout)\r\n\nE.U. Commission Directive 2003\/94\/EC (throughout)\r\n\nFDA Hazard Analysis Critical Control Point (throughout)\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\nIFS Food 7, Part 2 (throughout)\r\n\nIFS PACsecure 2, Part 2 (throughout)\r\n\nISO 15189:2012 (throughout)\r\n\nISO\/IEC 17025:2017 (throughout)\r\n\nISO\/TS 22002-1:2009 (throughout)\r\n\nISO\/TS 22002-4:2013 (throughout)\r\n\nISO\/TS 22002-6:2016 (throughout)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5 (throughout)\r\n\nOECD GLP Principles 8\r\n\nOSHA 1910.1020 (throughout)\r\n\nOSHA 1910.1200(b)(3)\r\n\nOSHA 1910.1450(h)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\nSQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nUSDA Data and Instrumentation for PDP (throughout)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines (throughout)\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3\r\n\nUSDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\nWADA International Standard for Laboratories (ISL) (throughout)\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\r\n\nWHO Technical Report Series, #961, Annex 13 (throughout)\r\n\nWHO Technical Report Series, #986, Annex 2 (throughout)\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.2 The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\n\n\n\n21 CFR Part 1.1154 (c)\r\n\n21 CFR Part 820.40 (a)\r\n\n42 CFR Part 493.1251 (e)\r\n\nA2LA C211 4.3\r\n\nAAVLD Requirements for an AVMDL Sec. 4.3\r\n\nASTM E1578-18 D-1-3\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nEPA 815-R-05-004 Chap. III, Sec. 11\r\n\nEPA ERLN Laboratory Requirements 4.2.4.2\r\n\nEPA QA\/G-5 2.1.9\r\n\nISO 15189:2012 4.3\r\n\nISO 15189:2012 5.5.3\r\n\nISO 15189:2012 5.9.3\r\n\nISO\/IEC 17025:2017 7.5.2\r\n\nISO\/IEC 17025:2017 8.3.2\r\n\nUSDA Administrative Procedures for the PDP 5.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.5\n\n\n7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.\n\n\nASTM E1578-18 D-1-4\n\n7.4 The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1151\r\n\n21 CFR Part 1.1152 (e)\r\n\n21 CFR Part 106.91 (c)\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.315\r\n\n21 CFR Part 111.320\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.160\r\n\n21 CFR Part 212.20 (c)\r\n\n21 CFR Part 212.60 (c)\r\n\n21 CFR Part 226.58 (e)\r\n\n21 CFR Part 820.250 (b)\r\n\n42 CFR Part 493.43 (c)\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nASTM E1578-18 D-1-5\r\n\nBRC GSFS, Issue 8, 5.6.1.1\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.3\r\n\nCodex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\nCodex Alimentarius CXS 234-1999 (throughout)\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 5\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\nIFS Food 7, Part 2, 5.5.2\r\n\nIFS Food 7, Part 2, 5.6.2\r\n\nIFS PACsecure 2, Part 2, 5.5.2\r\n\nIFS PACsecure 2, Part 2, 5.6.2\r\n\nISO\/IEC 17025:2017 6.5\r\n\nISO\/IEC 17025:2017 7.2.1.3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)\r\n\nUSDA Administrative Procedures for the PDP 8.4\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1\r\n\nWHO Technical Report Series, #986, Annex 2, 15.14\n\n\n7.5 The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1151\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.320\r\n\n21 CFR Part 212.20 (c)\r\n\n21 CFR Part 212.70 (b)\r\n\nA2LA C211 5.4.5\r\n\nA2LA C223 5.4\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.4\r\n\nABFT Accreditation Manual Sec. G-12, -14, and -15\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C10\r\n\nACMG Technical Standards for Clinical Genetics Laboratories F7.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4\r\n\nCodex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\nCodex Alimentarius CXS 234-1999 (throughout)\r\n\nEPA QA\/G-5 2.2.4\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\nISO\/IEC 17025:2017 7.2.2.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\nUSDA Administrative Procedures for the PDP 8.4\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6\r\n\nWHO Technical Report Series, #961, Annex 13, 10.1\r\n\nWHO Technical Report Series, #986, Annex 2, 4.11\r\n\nWHO Technical Report Series, #986, Annex 2, 15.13\n\n\n7.6 The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\n\n\n\n7 CFR Part 331.10\r\n\n7 CFR Part 331.15\r\n\n9 CFR Part 2.32\r\n\n9 CFR Part 121.10 \r\n\n9 CFR Part 121.15 \r\n\n10 CFR Part 30.34 (j-3)\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 11.10 (i)\r\n\n21 CFR Part 58.29\r\n\n21 CFR Part 211.25\r\n\n21 CFR Part 225.10\r\n\n21 CFR Part 226.10\r\n\n21 CFR Part 226.40\r\n\n21 CFR Part 820.25\r\n\n29 CFR Part 1910.134 (c)\r\n\n29 CFR Part 1910.1030 (g-2)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n29 CFR Part 1910.1200 (h)\r\n\n29 CFR Part 1910.1450 (f)\r\n\n40 CFR Part 262.207\r\n\n40 CFR Part 262.210\u201312\r\n\n42 CFR Part 73.10\r\n\n42 CFR Part 73.15\r\n\n42 CFR Part 493.43 (c)\r\n\n42 CFR Part 493.1235\r\n\n42 CFR Part 493.1251\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 417.5\r\n\nA2LA C211 5.2\r\n\nA2LA C223 5.2\r\n\nA2LA C223 5.7\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\nAAVLD Requirements for an AVMDL Appendix 1\r\n\nABFT Accreditation Manual Sec. B\r\n\nACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.4\r\n\nAIHA-LAP Policies 2022 (throughout)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASTM E1578-18 C-3-5\r\n\nASTM E1578-18 D-1-6\r\n\nASTM E1578-18 E-1-6\r\n\nBRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nCAP Laboratory Accreditation Manual\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCLSI QMS22 (throughout)\r\n\nE.U. Annex 11-2\r\n\nE.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\nEPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 1\r\n\nEPA QA\/G-5 2.1.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.1\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.1\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nISO 15189:2012 4.1.2.1\r\n\nISO 15189:2012 5.1.6\r\n\nISO 15189:2012 5.1.9\r\n\nISO\/IEC 17025:2017 6.2.2\r\n\nISO\/IEC 17025:2017 6.2.3\r\n\nISO\/IEC 17025:2017 6.2.5\r\n\nISO\/IEC 17025:2017 6.2.6\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nOECD GLP Principles 1.1.2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\n\n\n7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n\n\nASTM E1578-18 D-1-7\n\n7.8 The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\n\n\nAAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5\r\nEPA ERLN Laboratory Requirements 4.10.6\n\n7.9 The system shall support the addition of accurate cross-references and page numbers to new documents.\n\n\nAAVLD Requirements for an AVMDL Sec. 4.3.4\n\n7.10 The system shall be capable of uniquely identifying documents created in and added to the system.\n\n\nAPHL 2019 LIS Project Management Guidebook\r\n\n\n7.11 The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\n\n\n\n8. Resource management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n9 CFR Part 2.32\r\n\n10 CFR Part 20.2103\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 110.10 (c)\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.10\r\n\n29 CFR Part 1910.120\r\n\n29 CFR Part 1910.134 (m)\r\n\n29 CFR Part 1910.1030 (h-1)\r\n\n29 CFR Part 1910.1450 (j)\r\n\n40 CFR Part 262.207\r\n\nA2LA C211 4.13.2.3\r\n\nA2LA C223 5.2\r\n\nA2LA C223 5.7\r\n\nACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nBRC GSFS, Issue 8, 7.3.1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.2.3\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nEPA QA\/G-5 2.1.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.1\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.1\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nNIST 800-53, Rev. 5, AT-3 and -4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOSHA 1910.1020 (throughout)\r\n\nOSHA 1910.1200(b)(3) and (h)\r\n\nOSHA 1910.1450 (throughout)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nUSDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\r\n\nWHO Technical Report Series, #996, Annex 5, 8.1\n\n\n8.1 The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\n\n\n\n21 CFR Part 820.198\r\n\n42 CFR Part 493.1233\r\n\nBRC GSFS, Issue 8, 3.10.1\u20132\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21\r\n\nIFS Food 7, Part 2, 5.8\r\n\nIFS PACsecure 2, Part 2, 5.8\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)\r\n\nWADA International Standard for Laboratories (ISL) 5.3.10\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\n\n\n8.2 The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.\n\n\n\n5 CFR Part 930.301\r\n\n7 CFR Part 331.15\r\n\n9 CFR Part 121.15\r\n\n21 CFR Part 120.12\r\n\nhttps:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123 21 CFR Part 123.10]\r\n\n21 CFR Part 211.25\r\n\n29 CFR Part 1910.1450 (f)\r\n\n42 CFR Part 73.15\r\n\nA2LA C223 5.2\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3\r\n\nASTM E1578-18 E-1-1\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nCJIS Security Policy 5.2.1\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nNIST 800-53, Rev. 5, AT-2 and AT-3\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Sampling Procedures for PDP 6.1.2\u20133\r\n\nWHO Technical Report Series, #986, Annex 2, 10\n\n\n8.3 The system shall allow training sessions and reviews to be scheduled for personnel.\n\n\n\n5 CFR Part 930.301\r\n\n29 CFR Part 1910.1450 (f)\r\n\nABFT Accreditation Manual Sec. B\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7\r\n\nASTM E1578-18 E-1-2\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.4 The system should provide access to relevant training materials to personnel attending training sessions.\n\n\n\n5 CFR Part 930.301\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 110.10 (c)\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.10\r\n\n29 CFR Part 1910.1450 (f)\r\n\n40 CFR Part 262.207\r\n\nA2LA C223 5.2\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5\r\n\nASTM E1578-18 E-1-3\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.2.3\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nEPA QA\/G-5 2.1.8\r\n\nE.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nISO 15189:2012 5.1.9\r\n\nNIST 800-53, Rev. 5, AT-2\u2013AT-4\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e\r\n\nUSDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (e)\r\n\nWHO Technical Report Series, #986, Annex 2, 9.4\r\n\nWHO Technical Report Series, #986, Annex 2, 10\n\n\n8.5 The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\n\n\n\nABFT Accreditation Manual Sec. B\r\n\nASTM E1578-18 E-1-4\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\n\n\n8.6 The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\n\n\n\nASTM E1578-18 E-1-5\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nNIST 800-53, Rev. 5, AT-2 and AT-3\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.7 The system should be able to produce a training matrix of personnel.\n\n\n\n7 CFR Part 331.15\r\n\n9 CFR Part 121.10 \r\n\n9 CFR Part 121.15 \r\n\n21 CFR Part 11.10 (i)\r\n\n21 CFR Part 58.29\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 211.25\r\n\n21 CFR Part 225.10\r\n\n21 CFR Part 226.10\r\n\n21 CFR Part 226.40\r\n\n21 CFR Part 820.25\r\n\n29 CFR Part 1910.1030 (g-2)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n29 CFR Part 1910.1200 (h)\r\n\n29 CFR Part 1910.1450 (e)\r\n\n42 CFR Part 73.10\r\n\n42 CFR Part 73.15\r\n\n42 CFR Part 493.43 (c)\r\n\n42 CFR Part 493.1235\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nA2LA C223 5.2\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\nAAVLD Requirements for an AVMDL Appendix 1\r\n\nABFT Accreditation Manual Sec. B\r\n\nAIHA-LAP Policies 2022 (various parts)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASTM E1578-18 C-3-5\r\n\nASTM E1578-18 D-1-6\r\n\nASTM E1578-18 E-1-6\r\n\nBRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nE.U. Annex 11-2\r\n\nEPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 1\r\n\nEPA QA\/G-5 2.1.8\r\n\nISO 15189:2012 4.1.2.1\r\n\nISO 15189:2012 5.1.6\r\n\nISO 15189:2012 5.1.9\r\n\nISO\/IEC 17025:2017 6.2.2\r\n\nISO\/IEC 17025:2017 6.2.3\r\n\nISO\/IEC 17025:2017 6.2.5\r\n\nISO\/IEC 17025:2017 6.2.6\r\n\nOECD GLP Principles 1.1.2\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\n\n\n8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n\n\n\n9. Compliance management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17 \r\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1251 (d)\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nASTM E1578-18 C-4-7\r\n\nASTM E1578-18 E-2-1\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Annex 11-9\r\n\nE.U. Annex 11-14\r\n\nOECD GLP Principles 8.3.5\r\n\nUSDA Data and Instrumentation for PDP 8.1.3\n\n\n9.1 The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-2\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCJIS Security Policy Appendix G.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Annex 11-9\r\n\nE.U. Annex 11-12.4\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nNIST 800-53, Rev. 5, AC-2(4) and AC-6(9)\r\n\nNIST 800-53, Rev. 5, AU-2 and AU-3\r\n\nNIST 800-53, Rev. 5, CM-5(1)\r\n\nOECD GLP Principles 8.3.5\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n9.2 The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1274\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-3\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCLSI QMS22 2.2.3.2\r\n\nCLSI QMS22 2.4.3\r\n\nE.U. Annex 11-12.4\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nNIST 800-53, Rev. 5, AU-3 and AU-8\r\n\nOECD GLP Principles 8.3.5\r\n\nUSDA Data and Instrumentation for PDP 8.1.4\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.3 The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-4\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nICH GCP 4.9.0 and 4.9.3\r\n\nNIST 800-53, Rev. 5, AU-3\r\n\nOECD GLP Principles 8.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.4 The system's audit trail shall document the previous and current value of a modified field.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1251 (d)\r\n\n45 CFR Part 164.310\r\n\nASTM E1578-18 E-2-5\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nE.U. Annex 11-14\r\n\nOECD GLP Principles 8.3.5\n\n\n9.5 The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\n\n\n21 CFR Part 11.70\r\nE.U. Annex 11-14\n\n9.6 The system shall prevent a user from copying and pasting the electronic signature of another user.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 58.130 (e)\r\n\n42 CFR Part 493.1274 (d)\r\n\nE.U. Annex 11-9\r\n\nNIST 800-53, Rev. 5, AU-6 and AU-12\r\n\nOECD GLP Principles 8.3.5\n\n\n9.7 The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\n\n\n\n10. Instrument and equipment management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-3-1\n\n10.1 The system should provide a means for tracking usage of laboratory equipment and instruments.\n\n\nASTM E1578-18 E-3-2\n\n10.2 The system shall provide a means for planning the use of and reserving equipment and instruments.\n\n\nASTM E1578-18 E-3-3\n\n10.3 The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\n\n\nASTM E1578-18 E-3-4\n\n10.4 The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\n\n\nASTM E1578-18 E-3-5\n\n10.5 The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\n\n\nASTM E1578-18 E-3-6\n\n10.6 The system shall be able to group instruments together in specific ways, including by type and laboratory location.\n\n\n\n21 CFR Part 110.40 (f)\r\n\n21 CFR Part 211.67\u201368\r\n\n21 CFR Part 211.160 (b-4)\r\n\n21 CFR Part 212.30 (b)\r\n\n21 CFR Part 212.60 (e)\r\n\n21 CFR Part 225.30 (b-4)\r\n\n21 CFR Part 606.60\r\n\n21 CFR Part 820.70 (g)\r\n\n21 CFR Part 820.72\r\n\n42 CFR Part 493.1252 (b-3)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.5.2\r\n\nA2LA C223 5.5\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5\r\n\nABFT Accreditation Manual Sec. E-20\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1\r\n\nAIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\nASTM E1578-18 E-3-7\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.6.1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nISO 15189:2012 5.3.1.4\r\n\nISO\/IEC 17025:2017 6.4.7\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nISO\/TS 22002-4:2013, 4.7.1\r\n\nISO\/TS 22002-6:2016, 4.7\r\n\nNIST 800-53, Rev. 5, MA-2 and MA-2(2)\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Data and Instrumentation for PDP 5.2\r\n\nUSDA Data and Instrumentation for PDP 6\r\n\nWADA International Standard for Laboratories (ISL) 5.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 13.5\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\n\n\n\n21 CFR Part 225.30 (b-4)\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5.9\r\n\nASTM E1578-18 E-3-8\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.8 The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\n\n\n\n21 CFR Part 211.160 (b-4)\r\n\nA2LA C211 5.5.7\r\n\nA2LA C223 5.6\r\n\nABFT Accreditation Manual Sec. E-21\r\n\nASTM E1578-18 E-3-9\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nCLSI QMS22 2.1.2.1\r\n\nIFS Food 7, Part 2, 5.4.3\r\n\nIFS PACsecure 2, Part 2, 5.4.3\r\n\nISO 15189:2012 5.3.1.5\r\n\nISO\/IEC 17025:2017 6.4.9\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)\r\n\nWHO Technical Report Series, #986, Annex 2, 13.10\n\n\n10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.\n\n\n\n21 CFR Part 111.117\r\n\n21 CFR Part 820.72 (b-2)\r\n\nASTM E1578-18 E-3-10\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nNIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\n\n\n\n21 CFR Part 820.72 (b-1)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.6.2.1\r\n\nA2LA C223 5.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.6.1\u20132\r\n\nAIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nISO\/IEC 17025:2017 6.5\r\n\nISO\/TS 22002-4:2013, 4.7.1\r\n\nISO\/TS 22002-6:2016, 4.7\r\n\nOECD GLP Principles 4.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.2\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)\r\n\nUSDA Data and Instrumentation for PDP 6.1\n\n\n10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\n\n\nASTM E1578-18 E-3-11\n\n10.12 The system shall support the use of predefined intervals when calculating instrument event dates.\n\n\n\n21 CFR Part 110.40 (f)\r\n\n21 CFR Part 211.105 (b)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.5.4 and 5.5.5\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5.4\u20135\r\n\nASTM E1578-18 E-3-12\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1\r\n\nIFS Food 7, Part 2, 5.4.1\r\n\nIFS PACsecure 2, Part 2, 5.4.1\r\n\nISO 15189:2012 5.3.1.7\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nISO\/IEC 17025:2017 6.4.13\r\n\nNIST 800-53, Rev. 5, CM-8\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\nUSDA Administrative Procedures for the PDP 7.2\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4\r\n\nWHO Technical Report Series, #961, Annex 13, 6.1\n\n\n10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\n\n\nASTM E1578-18 E-3-13\n\n10.14 The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\n\n\n\n10 CFR Part 20.2103\r\n\n21 CFR Part 58.63\r\n\n21 CFR Part 111.117\r\n\n21 CFR Part 211.67\u201368\r\n\n21 CFR Part 211.160 (b-4)\r\n\n21 CFR Part 211.182\r\n\n21 CFR Part 211.194 (d)\r\n\n21 CFR Part 212.30 (b)\r\n\n21 CFR Part 212.60 (e)\r\n\n21 CFR Part 820.70 (g)\r\n\n21 CFR Part 820.72\r\n\n42 CFR Part 493.1254\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 4.13.2.1\r\n\nA2LA C211 5.5.2\r\n\nA2LA C211 5.10.4\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5\r\n\nABFT Accreditation Manual Sec. E-20 and -23\r\n\nABFT Accreditation Manual Sec. F-1 and I-1\r\n\nAIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\nASTM E1578-18 E-3-14\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.2.1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nISO 15189:2012 5.3.1.4\r\n\nISO\/IEC 17025:2017 6.4.4\r\n\nNIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 4.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Data and Instrumentation for PDP 5.4\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c\r\n\nWADA International Standard for Laboratories (ISL) 5.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 15.46\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.15 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\n\n\n\n11. Batch and lot management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 58.105 (a)\r\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nASTM E1578-18 E-4-1\r\n\nEPA ERLN Laboratory Requirements 3.3\r\n\nEPA ERLN Laboratory Requirements 4.10.1\r\n\nOECD GLP Principles 6.2\n\n\n11.1 The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\n\n\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nASTM E1578-18 E-4-2\r\n\nEPA ERLN Laboratory Requirements 4.10.1\n\n\n11.2 The system shall maintain the links between component parts of a batch and track the batch throughout the system.\n\n\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 820.65\r\n\nASTM E1578-18 E-4-3\n\n\n11.3 The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\n\n\nASTM E1578-18 E-4-4\n\n11.4 The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\n\n\nE.U. Annex 11-15\n\n11.5 The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\n\n\n\n12. Scheduled event management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 129.80 (g)\r\nASTM E1578-18 E-5-1\r\nUSDA Sampling Procedures for PDP 5.6\u20137\n\n12.1 The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.\n\n\n21 CFR Part 212.61 (a)\r\n21 CFR Part 211.166 (b)\r\nASTM E1578-18 E-5-2\n\n12.2 The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.\n\n\nASTM E1578-18 E-5-3\n\n12.3 The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\n\n\nASTM E1578-18 E-5-4\n\n12.4 The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).\n\n\nASTM E1578-18 E-5-5\n\n12.5 The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\n\n\n\n13. Instrument data capture and control \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-6-1\n\n13.1 The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\n\n\nASTM E1578-18 E-6-2\n\n13.2 The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\n\n\nASTM E1578-18 E-6-3\n\n13.3 The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\n\n\nASTM E1578-18 E-6-4\n\n13.4 The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\n\n\nASTM E1578-18 E-6-5\n\n13.5 The system should be able to accept the results uploaded from an interfaced instrument.\n\n\nASTM E1578-18 E-6-6\n\n13.6 The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\n\n\nASTM E1578-18 E-6-7\n\n13.7 The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\n\n\nASTM E1578-18 E-6-8\n\n13.8 The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\n\n\n\n14. Standard and reagent management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 58.83\r\n\n29 CFR Part 1910.1200 (g)\r\n\n29 CFR Part 1910.1450 (h)\r\n\n42 CFR Part 493.1252 (c)\r\n\nABFT Accreditation Manual Sec. E-17\r\n\nASTM E1578-18 E-7-1\r\n\nISO 15189:2012 5.3.2.4\u20135\r\n\nOECD GLP Principles 4.4\n\n\n14.1 The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\n\n\n\n7 CFR Part 331.3\r\n\n9 CFR Part 121.3\r\n\n21 CFR Part 312.58 (b)\r\n\n42 CFR Part 73.3\u20134 (c)\r\n\nASTM E1578-18 E-7-2\r\n\nEPA ERLN Laboratory Requirements 4.1.12\r\n\nISO 15189:2012 5.3.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 12.20\n\n\n14.2 The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\n\n\nASTM E1578-18 E-7-3\r\nISO 15189:2012 5.3.2.4\n\n14.3 The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\n\n\nASTM E1578-18 E-7-4\r\nISO 15189:2012 5.3.2.4\n\n14.4 The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\n\n\nASTM E1578-18 E-7-5\r\nISO 15189:2012 5.3.2.4\n\n14.5 The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\n\n\n\n15. Inventory management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-8-1\r\nCAP Laboratory Accreditation Manual\r\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples and specimens.\n\n\n\n21 CFR Part 212.60 (d)\r\n\nASTM E1578-18 E-8-2\r\n\nCLSI QMS22 2.1.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.2 The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\n\n\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.101\r\n\n21 CFR Part 212.60 (d)\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 606.120 (b)\r\n\n29 CFR Part 1910.1030 (g)\r\n\n29 CFR Part 1910.1096 (e-6)\r\n\n29 CFR Part 1910.1200 (f-6) and (f-10)\r\n\n40 CFR Part 262.206\r\n\nASTM E1578-18 E-8-3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOSHA 1910.1200(b)(3) and (f)\r\n\nOSHA 1910.1450(h)\r\n\nWHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41\r\n\nWHO Technical Report Series, #986, Annex 2, 15.10\u201312\n\n\n15.3 The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\n\n\n\n21 CFR Part 117.420\r\n\n21 CFR Part 212.40 (c)\r\n\n21 CFR Part 820.50\r\n\nA2LA C211 4.6\r\n\nASTM E1578-18 E-8-4\r\n\nBRC GSFS, Issue 8, 3.5.1.4\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5\r\n\nIFS Food 7, Part 2, 4.4.1\r\n\nIFS PACsecure 2, Part 2, 4.4.1\r\n\nISO\/TS 22002-1:2009, 9.2\r\n\nISO\/TS 22002-4:2013, 4.6.2\r\n\nISO\/TS 22002-6:2016, 4.6.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.4.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)\r\n\nUSDA Administrative Procedures for the PDP 7.1\r\n\nWHO Technical Report Series, #961, Annex 13, 7.1 and 7.3\r\n\nWHO Technical Report Series, #986, Annex 2, 14.8\n\n\n15.4 The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\n\n\n\n21 CFR Part 211.196\r\n\n21 CFR Part 212.90\r\n\n21 CFR Part 225.110\r\n\n21 CFR Part 606.165\r\n\n29 CFR Part 1910.1450 Appendix A (I)\r\n\nA2LA C211 4.6\r\n\nASTM E1578-18 E-8-5\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5\n\n\n15.5 The system should provide a means for accurately recording the receipt, approval, distribution, and disposal of materials.\n\n\n\n21 CFR Part 211.82 (b)\r\n\n21 CFR Part 211.84 (a)\r\n\n21 CFR Part 211.89\r\n\n21 CFR Part 211.110 (d)\r\n\n21 CFR Part 211.142 (a)\r\n\n21 CFR Part 212.40 (c)\r\n\nASTM E1578-18 E-8-6\r\n\nWHO Technical Report Series, #986, Annex 2, 12.18\n\n\n15.6 The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\n\n\n\n21 CFR Part 211.89\r\n\n21 CFR Part 211.110 (d)\r\n\n42 CFR Part 493.1252 (d)\r\n\nASTM E1578-18 E-8-7\n\n\n15.7 The system should allow authorized personnel to retire faulty or poor quality materials from use.\n\n\n\n21 CFR Part 211.89\r\nASTM E1578-18 E-8-8\n\n\n15.8 The system shall clearly designate a standard or reagent as being disposed or consumed.\n\n\n\n16. Investigation and quality management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 312.62 (b)\r\n21 CFR Part 812.140 (a-3)\n\n16.1 The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\n\n\n\n21 CFR Part 312.57 (a)\r\n\n21 CFR Part 312.62 (a)\r\n\n21 CFR Part 606.165\r\n\n21 CFR Part 812.140 (a-2) and (b-2)\n\n\n16.2 The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\n\n\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 58.81 (a)\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.111\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 211.194\r\n\n21 CFR Part 606.171\r\n\n42 CFR Part 493.1253 (b-2)\r\n\nA2LA C211 5.4\r\n\nABFT Accreditation Manual C-16\r\n\nABFT Accreditation Manual F-2\r\n\nABFT Accreditation Manual J-3\r\n\nASTM E1578-18 E-9-1\r\n\nBRC GSFS, Issue 8, 5.6.2.3\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nCLSI QMS22 2.2.2.2\r\n\nEPA ERLN Laboratory Requirements 3.3\r\n\nEPA QA\/G-5 2.2.4\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\nISO\/IEC 17025:2017 7.2.1.7\r\n\nISO\/IEC 17025:2017 7.2.2.1\r\n\nISO\/IEC 17025:2017 7.10.2\r\n\nISO\/IEC 17025:2017 8.7.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 7.3\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)\r\n\nUSDA Administrative Procedures for the PDP 8.2.2\r\n\nWADA International Standard for Laboratories (ISL) 5.3.6\r\n\nWHO Technical Report Series, #986, Annex 2, 16.3\n\n\n16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\n\n\n42 CFR Part 493.1282\r\nASTM E1578-18 E-9-2\r\nE.U. Commission Reg. No. 2073\/2005 Article 9\n\n16.4 The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\n\n\n\n21 CFR Part 606.100 (c)\r\n\n42 CFR Part 493.1282\r\n\nASTM E1578-18 E-9-3\r\n\nCLSI QMS22 2.1.2.1\r\n\nCLSI QMS22 2.2.2.3\r\n\nEPA QA\/G-5 2.2.10\r\n\nWHO Technical Report Series, #986, Annex 2, 17.12\r\n\nWHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.5 The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\n\n\n\n10 CFR Part 30.34 (g)\r\n\n21 CFR Part 112.147\r\n\n21 CFR Part 225.58 (d)\r\n\n21 CFR Part 225.158\r\n\n21 CFR Part 606.100 (c)\r\n\n21 CFR Part 820.100\r\n\n42 CFR Part 493.1282\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nA2LA C211 4.9 and 4.11\r\n\nASTM E1578-18 E-9-4\r\n\nBRC GSFS, Issue 8, 3.4.3\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCLSI QMS22 2.6.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nFDA Hazard Analysis Critical Control Point Principle 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5, IR-5\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\nWADA International Standard for Laboratories (ISL) 5.3.9\r\n\nWHO Technical Report Series, #961, Annex 13, 11.1\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\r\n\nWHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\n\n\n\n21 CFR Part 225.58 (d)\r\n\n21 CFR Part 225.158\r\n\n42 CFR Part 493.1282\r\n\n42 CFR Part 493.1289\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nA2LA C211 4.8 and 4.11\r\n\nASTM E1578-18 E-9-5\r\n\nBRC GSFS, Issue 8, 3.4.3\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.3.4\r\n\nCJIS Security Policy Appendix G.7\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nFDA Hazard Analysis Critical Control Point Principle 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5, AU-6(1)\r\n\nNIST 800-53, Rev. 5, IR-4(1) and IR-5\r\n\nNIST 800-53, Rev. 5, SI-2 and SI-4\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\n\n\n16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\n\n\nASTM E1578-18 E-9-6\n\n16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\n\n\n9 CFR Part 2.35\n\n16.9 The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#15._Inventory_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#15._Inventory_management<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 2 May 2022, at 22:08.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2,552 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","2d51a618475d6fdd30e9db36ce3c6512_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Maintaining_Laboratory_Workflow_and_Operations rootpage-LII_LIMSpec_Maintaining_Laboratory_Workflow_and_Operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Maintaining Laboratory Workflow and Operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"7._Document_and_records_management\">7. Document and records management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/part-20\" target=\"_blank\">10 CFR Part 20 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.213\u201314<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(e) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.1<\/b> The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.214<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.300\" target=\"_blank\">42 CFR Part 93.300\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1773\" target=\"_blank\">42 CFR Part 493.1773 (c\u2013d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/160.310\" target=\"_blank\">45 CFR Part 160.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 Appendix H5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.2<\/b> The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.3<\/b> The system shall be able to clearly provide the most current version of a document and archive prior versions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.4<\/b> The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.91 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.14<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.5<\/b> The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-12, -14, and -15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.13<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.6<\/b> The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.10\" target=\"_blank\">7 CFR Part 331.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (j-3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.210\" target=\"_blank\">40 CFR Part 262.210\u201312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.7<\/b> The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.8<\/b> The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.9<\/b> The system shall support the addition of accurate cross-references and page numbers to new documents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.10<\/b> The system shall be capable of uniquely identifying documents created in and added to the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>7.11<\/b> The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"8._Resource_management\">8. Resource management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (m)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-3 and -4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.1<\/b> The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.198\" target=\"_blank\">21 CFR Part 820.198<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1233\" target=\"_blank\">42 CFR Part 493.1233<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.10.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.2<\/b> The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123<\/a> 21 CFR Part 123.10]<br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.3<\/b> The system shall allow training sessions and reviews to be scheduled for personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.4<\/b> The system should provide access to relevant training materials to personnel attending training sessions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2\u2013AT-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.5<\/b> The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.6<\/b> The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.7<\/b> The system should be able to produce a training matrix of personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (various parts)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.8<\/b> The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"9._Compliance_management\">9. Compliance management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.1<\/b> The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-2 and AU-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.2<\/b> The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3 and AU-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.3<\/b> The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.4<\/b> The system's audit trail shall document the previous and current value of a modified field.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.5<\/b> The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>9.6<\/b> The system shall prevent a user from copying and pasting the electronic signature of another user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6 and AU-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.7<\/b> The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"10._Instrument_and_equipment_management\">10. Instrument and equipment management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.1<\/b> The system should provide a means for tracking usage of laboratory equipment and instruments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.2<\/b> The system shall provide a means for planning the use of and reserving equipment and instruments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.3<\/b> The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.4<\/b> The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.5<\/b> The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.6<\/b> The system shall be able to group instruments together in specific ways, including by type and laboratory location.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.60\" target=\"_blank\">21 CFR Part 606.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (b-3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2 and MA-2(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.7<\/b> The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.8<\/b> The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.9<\/b> The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.10<\/b> The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.6.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.11<\/b> The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.12<\/b> The system shall support the use of predefined intervals when calculating instrument event dates.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.4 and 5.5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.13<\/b> The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-13<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.14<\/b> The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.63\" target=\"_blank\">21 CFR Part 58.63<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.182\" target=\"_blank\">21 CFR Part 211.182<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1254\" target=\"_blank\">42 CFR Part 493.1254<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20 and -23<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. F-1 and I-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.46<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.15<\/b> The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"11._Batch_and_lot_management\">11. Batch and lot management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.1<\/b> The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.2<\/b> The system shall maintain the links between component parts of a batch and track the batch throughout the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.65\" target=\"_blank\">21 CFR Part 820.65<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.3<\/b> The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>11.4<\/b> The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-15<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>11.5<\/b> The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"12._Scheduled_event_management\">12. Scheduled event management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.6\u20137<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.1<\/b> The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.2<\/b> The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.3<\/b> The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.4<\/b> The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.5<\/b> The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"13._Instrument_data_capture_and_control\">13. Instrument data capture and control<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.1<\/b> The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.2<\/b> The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.3<\/b> The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.4<\/b> The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.5<\/b> The system should be able to accept the results uploaded from an interfaced instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.6<\/b> The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.7<\/b> The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.8<\/b> The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"14._Standard_and_reagent_management\">14. Standard and reagent management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.83\" target=\"_blank\">21 CFR Part 58.83<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>14.1<\/b> The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.3\" target=\"_blank\">7 CFR Part 331.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.3\" target=\"_blank\">9 CFR Part 121.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.3\" target=\"_blank\">42 CFR Part 73.3\u20134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.20<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>14.2<\/b> The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.3<\/b> The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.4<\/b> The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.5<\/b> The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"15._Inventory_management\">15. Inventory management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>15.1<\/b> The system should be capable of accurately tracking the specific quantities of received and consumed test samples and specimens.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.2<\/b> The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (f-6) and (f-10)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.206\" target=\"_blank\">40 CFR Part 262.206<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.10\u201312<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.3<\/b> The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.50\" target=\"_blank\">21 CFR Part 820.50<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.4<\/b> The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.196\" target=\"_blank\">21 CFR Part 211.196<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.90\" target=\"_blank\">21 CFR Part 212.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 Appendix A (I)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.5<\/b> The system should provide a means for accurately recording the receipt, approval, distribution, and disposal of materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.82\" target=\"_blank\">21 CFR Part 211.82 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.142\" target=\"_blank\">21 CFR Part 211.142 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.6<\/b> The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.7<\/b> The system should allow authorized personnel to retire faulty or poor quality materials from use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.8<\/b> The system shall clearly designate a standard or reagent as being disposed or consumed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"16._Investigation_and_quality_management\">16. Investigation and quality management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.1<\/b> The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-2) and (b-2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.2<\/b> The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.81\" target=\"_blank\">21 CFR Part 58.81 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.171\" target=\"_blank\">21 CFR Part 606.171<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1253\" target=\"_blank\">42 CFR Part 493.1253 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual F-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual J-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.3<\/b> The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.4<\/b> The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.5<\/b> The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.147<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.100\" target=\"_blank\">21 CFR Part 820.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.9 and 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 11.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.6<\/b> The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1289\" target=\"_blank\">42 CFR Part 493.1289<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.8 and 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-4(1) and IR-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2 and SI-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.7<\/b> The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.8<\/b> The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.9<\/b> The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173541\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.104 seconds\nReal time usage: 0.111 seconds\nPreprocessor visited node count: 1035\/1000000\nPost\u2010expand include size: 141529\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 20.237 1 -total\n 11.99% 2.426 1 Template:LIMSpec\/Document_management\n 10.55% 2.135 1 Template:LIMSpec\/Resource_management\n 9.87% 1.998 1 Template:LIMSpec\/Instrument_and_equipment_management\n 9.68% 1.958 1 Template:LIMSpec\/Compliance_management\n 9.13% 1.848 1 Template:LIMSpec\/Batch_and_lot_management\n 9.07% 1.836 1 Template:LIMSpec\/Investigation_and_quality_management\n 8.97% 1.815 1 Template:LIMSpec\/Inventory_management\n 8.81% 1.782 1 Template:LIMSpec\/Scheduled_event_management\n 8.72% 1.764 1 Template:LIMSpec\/Instrument_data_capture_and_control\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11181-0!canonical and timestamp 20221202173541 and revision id 47569. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#15._Inventory_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#15._Inventory_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","2d51a618475d6fdd30e9db36ce3c6512_images":[],"2d51a618475d6fdd30e9db36ce3c6512_timestamp":1670002543,"9f172b7fc3c58eff808f985a33cdba7e_type":"article","9f172b7fc3c58eff808f985a33cdba7e_title":"14. Standard and reagent management","9f172b7fc3c58eff808f985a33cdba7e_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#14._Standard_and_reagent_management","9f172b7fc3c58eff808f985a33cdba7e_plaintext":"\n\nLII:LIMSpec\/Maintaining Laboratory Workflow and OperationsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.\n\n7. Document and records management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n7 CFR Part 331 (throughout)\r\n\n9 CFR Part 121 (throughout)\r\n\n10 CFR Part 20 (throughout)\r\n\n21 CFR Part 7 (throughout)\r\n\n21 CFR Part 117 (throughout)\r\n\n21 CFR Part 58 (throughout)\r\n\n21 CFR Part 211 (throughout)\r\n\n21 CFR Part 212 (throughout)\r\n\n21 CFR Part 225 (throughout)\r\n\n21 CFR Part 226 (throughout)\r\n\n21 CFR Part 312 (throughout)\r\n\n21 CFR Part 606 (throughout)\r\n\n21 CFR Part 810 (throughout)\r\n\n21 CFR Part 812 (throughout)\r\n\n21 CFR Part 820 (throughout)\r\n\n29 CFR Part 1910.134 (throughout)\r\n\n29 CFR Part 1910.1030 (throughout)\r\n\n29 CFR Part 1910.1200 (throughout)\r\n\n29 CFR Part 1910.1450 (throughout)\r\n\n40 CFR Part 262.213\u201314\r\n\n42 CFR Part 73 (throughout)\r\n\n42 CFR Part 493.1200\r\n\n42 CFR Part 493.1232\r\n\n42 CFR Part 493.1239\r\n\n42 CFR Part 493.1251\r\n\n42 CFR Part 493.1291 (j)\r\n\n45 CFR Part 164 (throughout)\r\n\n61 FR 38806 (throughout)\r\n\nA2LA C211 4.3\r\n\nA2LA C223 4.13\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\nAAVLD Requirements for an AVMDL (throughout)\r\n\nABFT Accreditation Manual (throughout)\r\n\nASTM E1188-11 3.5.2\r\n\nASTM E1492-11 4.3.3.3 and 4.4.4\r\n\nASTM E1578-18 D-1-1\r\n\nBRC GSFS, Issue 8, 3.1.1\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nBRC GSFS, Issue 8, 5.6.1.1\r\n\nBRC GSFS, Issue 8, 5.6.2.2\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual (throughout)\r\n\nCJIS Security Policy (throughout)\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)\r\n\nEPA 815-R-05-004 (throughout)\r\n\nEPA ERLN Laboratory Requirements (throughout)\r\n\nEPA QA\/G-5 (throughout)\r\n\nE.U. Commission Directive 2003\/94\/EC (throughout)\r\n\nFDA Hazard Analysis Critical Control Point (throughout)\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\nIFS Food 7, Part 2 (throughout)\r\n\nIFS PACsecure 2, Part 2 (throughout)\r\n\nISO 15189:2012 4.3\r\n\nISO 15189:2012 5.5.3\r\n\nISO 15189:2012 5.9.3\r\n\nISO\/IEC 17025:2017 5.3\r\n\nISO\/IEC 17025:2017 5.5\r\n\nISO\/IEC 17025:2017 8.3.2\r\n\nISO\/TS 22002-1:2009 (throughout)\r\n\nISO\/TS 22002-4:2013 (throughout)\r\n\nISO\/TS 22002-6:2016 (throughout)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5 (throughout)\r\n\nOECD GLP Principles 8\r\n\nOSHA 1910.1200(b)(3)\r\n\nOSHA 1910.1450(e) and (h)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\nSQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nUSDA Data and Instrumentation for PDP (throughout)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\nWHO Technical Report Series, #961, Annex 13 (throughout)\r\n\nWHO Technical Report Series, #986, Annex 2 (throughout)\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\n\n\n\n7 CFR Part 331 (throughout)\r\n\n9 CFR Part 121 (throughout)\r\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 7 (throughout)\r\n\n21 CFR Part 58 (throughout)\r\n\n21 CFR Part 117 (throughout)\r\n\n21 CFR Part 211 (throughout)\r\n\n21 CFR Part 212 (throughout)\r\n\n21 CFR Part 225 (throughout)\r\n\n21 CFR Part 226 (throughout)\r\n\n21 CFR Part 312 (throughout)\r\n\n21 CFR Part 606 (throughout)\r\n\n21 CFR Part 810 (throughout)\r\n\n21 CFR Part 812 (throughout)\r\n\n21 CFR Part 820 (throughout)\r\n\n29 CFR Part 1910.134 (c)\r\n\n29 CFR Part 1910.1030 (throughout)\r\n\n29 CFR Part 1910.1200 (e)\r\n\n29 CFR Part 1910.1450 (throughout)\r\n\n40 CFR Part 262.214\r\n\n42 CFR Part 73 (throughout)\r\n\n42 CFR Part 93.300\u20135\r\n\n42 CFR Part 493.1200\r\n\n42 CFR Part 493.1232\r\n\n42 CFR Part 493.1239\r\n\n42 CFR Part 493.1251\r\n\n42 CFR Part 493.1291 (j)\r\n\n42 CFR Part 493.1773 (c\u2013d)\r\n\n45 CFR Part 160.310\r\n\n45 CFR Part 164 (throughout)\r\n\n61 FR 38806 (throughout)\r\n\nA2LA C211 (throughout)\r\n\nA2LA C223 (throughout)\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\nAAVLD Requirements for an AVMDL (throughout)\r\n\nACMG Technical Standards for Clinical Genetics Laboratories (throughout)\r\n\nAIHA-LAP Policies 2022 Appendix H5.8\r\n\nASTM E1188-11 3.5.2\r\n\nASTM E1492-11 4.3.3.3 and 4.4.4\r\n\nASTM E1578-18 D-1-2\r\n\nBRC GSFS, Issue 8, 3.1.2\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nBRC GSFS, Issue 8, 5.6.2.2\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual (throughout)\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)\r\n\nCJIS Security Policy (throughout)\r\n\nCLSI QMS22 (throughout)\r\n\nEPA 815-R-05-004 (throughout)\r\n\nEPA ERLN Laboratory Requirements (throughout)\r\n\nEPA QA\/G-5 (throughout)\r\n\nE.U. Commission Directive 2003\/94\/EC (throughout)\r\n\nFDA Hazard Analysis Critical Control Point (throughout)\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\nIFS Food 7, Part 2 (throughout)\r\n\nIFS PACsecure 2, Part 2 (throughout)\r\n\nISO 15189:2012 (throughout)\r\n\nISO\/IEC 17025:2017 (throughout)\r\n\nISO\/TS 22002-1:2009 (throughout)\r\n\nISO\/TS 22002-4:2013 (throughout)\r\n\nISO\/TS 22002-6:2016 (throughout)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5 (throughout)\r\n\nOECD GLP Principles 8\r\n\nOSHA 1910.1020 (throughout)\r\n\nOSHA 1910.1200(b)(3)\r\n\nOSHA 1910.1450(h)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\nSQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nUSDA Data and Instrumentation for PDP (throughout)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines (throughout)\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3\r\n\nUSDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\nWADA International Standard for Laboratories (ISL) (throughout)\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\r\n\nWHO Technical Report Series, #961, Annex 13 (throughout)\r\n\nWHO Technical Report Series, #986, Annex 2 (throughout)\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.2 The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\n\n\n\n21 CFR Part 1.1154 (c)\r\n\n21 CFR Part 820.40 (a)\r\n\n42 CFR Part 493.1251 (e)\r\n\nA2LA C211 4.3\r\n\nAAVLD Requirements for an AVMDL Sec. 4.3\r\n\nASTM E1578-18 D-1-3\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nEPA 815-R-05-004 Chap. III, Sec. 11\r\n\nEPA ERLN Laboratory Requirements 4.2.4.2\r\n\nEPA QA\/G-5 2.1.9\r\n\nISO 15189:2012 4.3\r\n\nISO 15189:2012 5.5.3\r\n\nISO 15189:2012 5.9.3\r\n\nISO\/IEC 17025:2017 7.5.2\r\n\nISO\/IEC 17025:2017 8.3.2\r\n\nUSDA Administrative Procedures for the PDP 5.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.5\n\n\n7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.\n\n\nASTM E1578-18 D-1-4\n\n7.4 The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1151\r\n\n21 CFR Part 1.1152 (e)\r\n\n21 CFR Part 106.91 (c)\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.315\r\n\n21 CFR Part 111.320\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.160\r\n\n21 CFR Part 212.20 (c)\r\n\n21 CFR Part 212.60 (c)\r\n\n21 CFR Part 226.58 (e)\r\n\n21 CFR Part 820.250 (b)\r\n\n42 CFR Part 493.43 (c)\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nASTM E1578-18 D-1-5\r\n\nBRC GSFS, Issue 8, 5.6.1.1\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.3\r\n\nCodex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\nCodex Alimentarius CXS 234-1999 (throughout)\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 5\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\nIFS Food 7, Part 2, 5.5.2\r\n\nIFS Food 7, Part 2, 5.6.2\r\n\nIFS PACsecure 2, Part 2, 5.5.2\r\n\nIFS PACsecure 2, Part 2, 5.6.2\r\n\nISO\/IEC 17025:2017 6.5\r\n\nISO\/IEC 17025:2017 7.2.1.3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)\r\n\nUSDA Administrative Procedures for the PDP 8.4\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1\r\n\nWHO Technical Report Series, #986, Annex 2, 15.14\n\n\n7.5 The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1151\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.320\r\n\n21 CFR Part 212.20 (c)\r\n\n21 CFR Part 212.70 (b)\r\n\nA2LA C211 5.4.5\r\n\nA2LA C223 5.4\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.4\r\n\nABFT Accreditation Manual Sec. G-12, -14, and -15\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C10\r\n\nACMG Technical Standards for Clinical Genetics Laboratories F7.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4\r\n\nCodex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\nCodex Alimentarius CXS 234-1999 (throughout)\r\n\nEPA QA\/G-5 2.2.4\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\nISO\/IEC 17025:2017 7.2.2.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\nUSDA Administrative Procedures for the PDP 8.4\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6\r\n\nWHO Technical Report Series, #961, Annex 13, 10.1\r\n\nWHO Technical Report Series, #986, Annex 2, 4.11\r\n\nWHO Technical Report Series, #986, Annex 2, 15.13\n\n\n7.6 The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\n\n\n\n7 CFR Part 331.10\r\n\n7 CFR Part 331.15\r\n\n9 CFR Part 2.32\r\n\n9 CFR Part 121.10 \r\n\n9 CFR Part 121.15 \r\n\n10 CFR Part 30.34 (j-3)\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 11.10 (i)\r\n\n21 CFR Part 58.29\r\n\n21 CFR Part 211.25\r\n\n21 CFR Part 225.10\r\n\n21 CFR Part 226.10\r\n\n21 CFR Part 226.40\r\n\n21 CFR Part 820.25\r\n\n29 CFR Part 1910.134 (c)\r\n\n29 CFR Part 1910.1030 (g-2)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n29 CFR Part 1910.1200 (h)\r\n\n29 CFR Part 1910.1450 (f)\r\n\n40 CFR Part 262.207\r\n\n40 CFR Part 262.210\u201312\r\n\n42 CFR Part 73.10\r\n\n42 CFR Part 73.15\r\n\n42 CFR Part 493.43 (c)\r\n\n42 CFR Part 493.1235\r\n\n42 CFR Part 493.1251\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 417.5\r\n\nA2LA C211 5.2\r\n\nA2LA C223 5.2\r\n\nA2LA C223 5.7\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\nAAVLD Requirements for an AVMDL Appendix 1\r\n\nABFT Accreditation Manual Sec. B\r\n\nACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.4\r\n\nAIHA-LAP Policies 2022 (throughout)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASTM E1578-18 C-3-5\r\n\nASTM E1578-18 D-1-6\r\n\nASTM E1578-18 E-1-6\r\n\nBRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nCAP Laboratory Accreditation Manual\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCLSI QMS22 (throughout)\r\n\nE.U. Annex 11-2\r\n\nE.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\nEPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 1\r\n\nEPA QA\/G-5 2.1.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.1\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.1\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nISO 15189:2012 4.1.2.1\r\n\nISO 15189:2012 5.1.6\r\n\nISO 15189:2012 5.1.9\r\n\nISO\/IEC 17025:2017 6.2.2\r\n\nISO\/IEC 17025:2017 6.2.3\r\n\nISO\/IEC 17025:2017 6.2.5\r\n\nISO\/IEC 17025:2017 6.2.6\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nOECD GLP Principles 1.1.2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\n\n\n7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n\n\nASTM E1578-18 D-1-7\n\n7.8 The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\n\n\nAAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5\r\nEPA ERLN Laboratory Requirements 4.10.6\n\n7.9 The system shall support the addition of accurate cross-references and page numbers to new documents.\n\n\nAAVLD Requirements for an AVMDL Sec. 4.3.4\n\n7.10 The system shall be capable of uniquely identifying documents created in and added to the system.\n\n\nAPHL 2019 LIS Project Management Guidebook\r\n\n\n7.11 The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\n\n\n\n8. Resource management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n9 CFR Part 2.32\r\n\n10 CFR Part 20.2103\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 110.10 (c)\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.10\r\n\n29 CFR Part 1910.120\r\n\n29 CFR Part 1910.134 (m)\r\n\n29 CFR Part 1910.1030 (h-1)\r\n\n29 CFR Part 1910.1450 (j)\r\n\n40 CFR Part 262.207\r\n\nA2LA C211 4.13.2.3\r\n\nA2LA C223 5.2\r\n\nA2LA C223 5.7\r\n\nACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nBRC GSFS, Issue 8, 7.3.1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.2.3\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nEPA QA\/G-5 2.1.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.1\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.1\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nNIST 800-53, Rev. 5, AT-3 and -4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOSHA 1910.1020 (throughout)\r\n\nOSHA 1910.1200(b)(3) and (h)\r\n\nOSHA 1910.1450 (throughout)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nUSDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\r\n\nWHO Technical Report Series, #996, Annex 5, 8.1\n\n\n8.1 The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\n\n\n\n21 CFR Part 820.198\r\n\n42 CFR Part 493.1233\r\n\nBRC GSFS, Issue 8, 3.10.1\u20132\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21\r\n\nIFS Food 7, Part 2, 5.8\r\n\nIFS PACsecure 2, Part 2, 5.8\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)\r\n\nWADA International Standard for Laboratories (ISL) 5.3.10\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\n\n\n8.2 The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.\n\n\n\n5 CFR Part 930.301\r\n\n7 CFR Part 331.15\r\n\n9 CFR Part 121.15\r\n\n21 CFR Part 120.12\r\n\nhttps:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123 21 CFR Part 123.10]\r\n\n21 CFR Part 211.25\r\n\n29 CFR Part 1910.1450 (f)\r\n\n42 CFR Part 73.15\r\n\nA2LA C223 5.2\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3\r\n\nASTM E1578-18 E-1-1\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nCJIS Security Policy 5.2.1\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nNIST 800-53, Rev. 5, AT-2 and AT-3\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Sampling Procedures for PDP 6.1.2\u20133\r\n\nWHO Technical Report Series, #986, Annex 2, 10\n\n\n8.3 The system shall allow training sessions and reviews to be scheduled for personnel.\n\n\n\n5 CFR Part 930.301\r\n\n29 CFR Part 1910.1450 (f)\r\n\nABFT Accreditation Manual Sec. B\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7\r\n\nASTM E1578-18 E-1-2\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.4 The system should provide access to relevant training materials to personnel attending training sessions.\n\n\n\n5 CFR Part 930.301\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 110.10 (c)\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.10\r\n\n29 CFR Part 1910.1450 (f)\r\n\n40 CFR Part 262.207\r\n\nA2LA C223 5.2\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5\r\n\nASTM E1578-18 E-1-3\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.2.3\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nEPA QA\/G-5 2.1.8\r\n\nE.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nISO 15189:2012 5.1.9\r\n\nNIST 800-53, Rev. 5, AT-2\u2013AT-4\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e\r\n\nUSDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (e)\r\n\nWHO Technical Report Series, #986, Annex 2, 9.4\r\n\nWHO Technical Report Series, #986, Annex 2, 10\n\n\n8.5 The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\n\n\n\nABFT Accreditation Manual Sec. B\r\n\nASTM E1578-18 E-1-4\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\n\n\n8.6 The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\n\n\n\nASTM E1578-18 E-1-5\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nNIST 800-53, Rev. 5, AT-2 and AT-3\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.7 The system should be able to produce a training matrix of personnel.\n\n\n\n7 CFR Part 331.15\r\n\n9 CFR Part 121.10 \r\n\n9 CFR Part 121.15 \r\n\n21 CFR Part 11.10 (i)\r\n\n21 CFR Part 58.29\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 211.25\r\n\n21 CFR Part 225.10\r\n\n21 CFR Part 226.10\r\n\n21 CFR Part 226.40\r\n\n21 CFR Part 820.25\r\n\n29 CFR Part 1910.1030 (g-2)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n29 CFR Part 1910.1200 (h)\r\n\n29 CFR Part 1910.1450 (e)\r\n\n42 CFR Part 73.10\r\n\n42 CFR Part 73.15\r\n\n42 CFR Part 493.43 (c)\r\n\n42 CFR Part 493.1235\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nA2LA C223 5.2\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\nAAVLD Requirements for an AVMDL Appendix 1\r\n\nABFT Accreditation Manual Sec. B\r\n\nAIHA-LAP Policies 2022 (various parts)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASTM E1578-18 C-3-5\r\n\nASTM E1578-18 D-1-6\r\n\nASTM E1578-18 E-1-6\r\n\nBRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nE.U. Annex 11-2\r\n\nEPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 1\r\n\nEPA QA\/G-5 2.1.8\r\n\nISO 15189:2012 4.1.2.1\r\n\nISO 15189:2012 5.1.6\r\n\nISO 15189:2012 5.1.9\r\n\nISO\/IEC 17025:2017 6.2.2\r\n\nISO\/IEC 17025:2017 6.2.3\r\n\nISO\/IEC 17025:2017 6.2.5\r\n\nISO\/IEC 17025:2017 6.2.6\r\n\nOECD GLP Principles 1.1.2\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\n\n\n8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n\n\n\n9. Compliance management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17 \r\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1251 (d)\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nASTM E1578-18 C-4-7\r\n\nASTM E1578-18 E-2-1\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Annex 11-9\r\n\nE.U. Annex 11-14\r\n\nOECD GLP Principles 8.3.5\r\n\nUSDA Data and Instrumentation for PDP 8.1.3\n\n\n9.1 The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-2\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCJIS Security Policy Appendix G.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Annex 11-9\r\n\nE.U. Annex 11-12.4\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nNIST 800-53, Rev. 5, AC-2(4) and AC-6(9)\r\n\nNIST 800-53, Rev. 5, AU-2 and AU-3\r\n\nNIST 800-53, Rev. 5, CM-5(1)\r\n\nOECD GLP Principles 8.3.5\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n9.2 The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1274\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-3\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCLSI QMS22 2.2.3.2\r\n\nCLSI QMS22 2.4.3\r\n\nE.U. Annex 11-12.4\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nNIST 800-53, Rev. 5, AU-3 and AU-8\r\n\nOECD GLP Principles 8.3.5\r\n\nUSDA Data and Instrumentation for PDP 8.1.4\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.3 The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-4\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nICH GCP 4.9.0 and 4.9.3\r\n\nNIST 800-53, Rev. 5, AU-3\r\n\nOECD GLP Principles 8.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.4 The system's audit trail shall document the previous and current value of a modified field.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1251 (d)\r\n\n45 CFR Part 164.310\r\n\nASTM E1578-18 E-2-5\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nE.U. Annex 11-14\r\n\nOECD GLP Principles 8.3.5\n\n\n9.5 The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\n\n\n21 CFR Part 11.70\r\nE.U. Annex 11-14\n\n9.6 The system shall prevent a user from copying and pasting the electronic signature of another user.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 58.130 (e)\r\n\n42 CFR Part 493.1274 (d)\r\n\nE.U. Annex 11-9\r\n\nNIST 800-53, Rev. 5, AU-6 and AU-12\r\n\nOECD GLP Principles 8.3.5\n\n\n9.7 The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\n\n\n\n10. Instrument and equipment management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-3-1\n\n10.1 The system should provide a means for tracking usage of laboratory equipment and instruments.\n\n\nASTM E1578-18 E-3-2\n\n10.2 The system shall provide a means for planning the use of and reserving equipment and instruments.\n\n\nASTM E1578-18 E-3-3\n\n10.3 The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\n\n\nASTM E1578-18 E-3-4\n\n10.4 The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\n\n\nASTM E1578-18 E-3-5\n\n10.5 The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\n\n\nASTM E1578-18 E-3-6\n\n10.6 The system shall be able to group instruments together in specific ways, including by type and laboratory location.\n\n\n\n21 CFR Part 110.40 (f)\r\n\n21 CFR Part 211.67\u201368\r\n\n21 CFR Part 211.160 (b-4)\r\n\n21 CFR Part 212.30 (b)\r\n\n21 CFR Part 212.60 (e)\r\n\n21 CFR Part 225.30 (b-4)\r\n\n21 CFR Part 606.60\r\n\n21 CFR Part 820.70 (g)\r\n\n21 CFR Part 820.72\r\n\n42 CFR Part 493.1252 (b-3)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.5.2\r\n\nA2LA C223 5.5\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5\r\n\nABFT Accreditation Manual Sec. E-20\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1\r\n\nAIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\nASTM E1578-18 E-3-7\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.6.1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nISO 15189:2012 5.3.1.4\r\n\nISO\/IEC 17025:2017 6.4.7\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nISO\/TS 22002-4:2013, 4.7.1\r\n\nISO\/TS 22002-6:2016, 4.7\r\n\nNIST 800-53, Rev. 5, MA-2 and MA-2(2)\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Data and Instrumentation for PDP 5.2\r\n\nUSDA Data and Instrumentation for PDP 6\r\n\nWADA International Standard for Laboratories (ISL) 5.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 13.5\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\n\n\n\n21 CFR Part 225.30 (b-4)\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5.9\r\n\nASTM E1578-18 E-3-8\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.8 The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\n\n\n\n21 CFR Part 211.160 (b-4)\r\n\nA2LA C211 5.5.7\r\n\nA2LA C223 5.6\r\n\nABFT Accreditation Manual Sec. E-21\r\n\nASTM E1578-18 E-3-9\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nCLSI QMS22 2.1.2.1\r\n\nIFS Food 7, Part 2, 5.4.3\r\n\nIFS PACsecure 2, Part 2, 5.4.3\r\n\nISO 15189:2012 5.3.1.5\r\n\nISO\/IEC 17025:2017 6.4.9\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)\r\n\nWHO Technical Report Series, #986, Annex 2, 13.10\n\n\n10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.\n\n\n\n21 CFR Part 111.117\r\n\n21 CFR Part 820.72 (b-2)\r\n\nASTM E1578-18 E-3-10\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nNIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\n\n\n\n21 CFR Part 820.72 (b-1)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.6.2.1\r\n\nA2LA C223 5.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.6.1\u20132\r\n\nAIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nISO\/IEC 17025:2017 6.5\r\n\nISO\/TS 22002-4:2013, 4.7.1\r\n\nISO\/TS 22002-6:2016, 4.7\r\n\nOECD GLP Principles 4.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.2\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)\r\n\nUSDA Data and Instrumentation for PDP 6.1\n\n\n10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\n\n\nASTM E1578-18 E-3-11\n\n10.12 The system shall support the use of predefined intervals when calculating instrument event dates.\n\n\n\n21 CFR Part 110.40 (f)\r\n\n21 CFR Part 211.105 (b)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.5.4 and 5.5.5\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5.4\u20135\r\n\nASTM E1578-18 E-3-12\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1\r\n\nIFS Food 7, Part 2, 5.4.1\r\n\nIFS PACsecure 2, Part 2, 5.4.1\r\n\nISO 15189:2012 5.3.1.7\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nISO\/IEC 17025:2017 6.4.13\r\n\nNIST 800-53, Rev. 5, CM-8\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\nUSDA Administrative Procedures for the PDP 7.2\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4\r\n\nWHO Technical Report Series, #961, Annex 13, 6.1\n\n\n10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\n\n\nASTM E1578-18 E-3-13\n\n10.14 The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\n\n\n\n10 CFR Part 20.2103\r\n\n21 CFR Part 58.63\r\n\n21 CFR Part 111.117\r\n\n21 CFR Part 211.67\u201368\r\n\n21 CFR Part 211.160 (b-4)\r\n\n21 CFR Part 211.182\r\n\n21 CFR Part 211.194 (d)\r\n\n21 CFR Part 212.30 (b)\r\n\n21 CFR Part 212.60 (e)\r\n\n21 CFR Part 820.70 (g)\r\n\n21 CFR Part 820.72\r\n\n42 CFR Part 493.1254\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 4.13.2.1\r\n\nA2LA C211 5.5.2\r\n\nA2LA C211 5.10.4\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5\r\n\nABFT Accreditation Manual Sec. E-20 and -23\r\n\nABFT Accreditation Manual Sec. F-1 and I-1\r\n\nAIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\nASTM E1578-18 E-3-14\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.2.1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nISO 15189:2012 5.3.1.4\r\n\nISO\/IEC 17025:2017 6.4.4\r\n\nNIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 4.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Data and Instrumentation for PDP 5.4\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c\r\n\nWADA International Standard for Laboratories (ISL) 5.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 15.46\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.15 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\n\n\n\n11. Batch and lot management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 58.105 (a)\r\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nASTM E1578-18 E-4-1\r\n\nEPA ERLN Laboratory Requirements 3.3\r\n\nEPA ERLN Laboratory Requirements 4.10.1\r\n\nOECD GLP Principles 6.2\n\n\n11.1 The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\n\n\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nASTM E1578-18 E-4-2\r\n\nEPA ERLN Laboratory Requirements 4.10.1\n\n\n11.2 The system shall maintain the links between component parts of a batch and track the batch throughout the system.\n\n\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 820.65\r\n\nASTM E1578-18 E-4-3\n\n\n11.3 The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\n\n\nASTM E1578-18 E-4-4\n\n11.4 The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\n\n\nE.U. Annex 11-15\n\n11.5 The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\n\n\n\n12. Scheduled event management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 129.80 (g)\r\nASTM E1578-18 E-5-1\r\nUSDA Sampling Procedures for PDP 5.6\u20137\n\n12.1 The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.\n\n\n21 CFR Part 212.61 (a)\r\n21 CFR Part 211.166 (b)\r\nASTM E1578-18 E-5-2\n\n12.2 The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.\n\n\nASTM E1578-18 E-5-3\n\n12.3 The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\n\n\nASTM E1578-18 E-5-4\n\n12.4 The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).\n\n\nASTM E1578-18 E-5-5\n\n12.5 The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\n\n\n\n13. Instrument data capture and control \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-6-1\n\n13.1 The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\n\n\nASTM E1578-18 E-6-2\n\n13.2 The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\n\n\nASTM E1578-18 E-6-3\n\n13.3 The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\n\n\nASTM E1578-18 E-6-4\n\n13.4 The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\n\n\nASTM E1578-18 E-6-5\n\n13.5 The system should be able to accept the results uploaded from an interfaced instrument.\n\n\nASTM E1578-18 E-6-6\n\n13.6 The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\n\n\nASTM E1578-18 E-6-7\n\n13.7 The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\n\n\nASTM E1578-18 E-6-8\n\n13.8 The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\n\n\n\n14. Standard and reagent management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 58.83\r\n\n29 CFR Part 1910.1200 (g)\r\n\n29 CFR Part 1910.1450 (h)\r\n\n42 CFR Part 493.1252 (c)\r\n\nABFT Accreditation Manual Sec. E-17\r\n\nASTM E1578-18 E-7-1\r\n\nISO 15189:2012 5.3.2.4\u20135\r\n\nOECD GLP Principles 4.4\n\n\n14.1 The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\n\n\n\n7 CFR Part 331.3\r\n\n9 CFR Part 121.3\r\n\n21 CFR Part 312.58 (b)\r\n\n42 CFR Part 73.3\u20134 (c)\r\n\nASTM E1578-18 E-7-2\r\n\nEPA ERLN Laboratory Requirements 4.1.12\r\n\nISO 15189:2012 5.3.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 12.20\n\n\n14.2 The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\n\n\nASTM E1578-18 E-7-3\r\nISO 15189:2012 5.3.2.4\n\n14.3 The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\n\n\nASTM E1578-18 E-7-4\r\nISO 15189:2012 5.3.2.4\n\n14.4 The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\n\n\nASTM E1578-18 E-7-5\r\nISO 15189:2012 5.3.2.4\n\n14.5 The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\n\n\n\n15. Inventory management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-8-1\r\nCAP Laboratory Accreditation Manual\r\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples and specimens.\n\n\n\n21 CFR Part 212.60 (d)\r\n\nASTM E1578-18 E-8-2\r\n\nCLSI QMS22 2.1.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.2 The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\n\n\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.101\r\n\n21 CFR Part 212.60 (d)\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 606.120 (b)\r\n\n29 CFR Part 1910.1030 (g)\r\n\n29 CFR Part 1910.1096 (e-6)\r\n\n29 CFR Part 1910.1200 (f-6) and (f-10)\r\n\n40 CFR Part 262.206\r\n\nASTM E1578-18 E-8-3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOSHA 1910.1200(b)(3) and (f)\r\n\nOSHA 1910.1450(h)\r\n\nWHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41\r\n\nWHO Technical Report Series, #986, Annex 2, 15.10\u201312\n\n\n15.3 The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\n\n\n\n21 CFR Part 117.420\r\n\n21 CFR Part 212.40 (c)\r\n\n21 CFR Part 820.50\r\n\nA2LA C211 4.6\r\n\nASTM E1578-18 E-8-4\r\n\nBRC GSFS, Issue 8, 3.5.1.4\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5\r\n\nIFS Food 7, Part 2, 4.4.1\r\n\nIFS PACsecure 2, Part 2, 4.4.1\r\n\nISO\/TS 22002-1:2009, 9.2\r\n\nISO\/TS 22002-4:2013, 4.6.2\r\n\nISO\/TS 22002-6:2016, 4.6.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.4.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)\r\n\nUSDA Administrative Procedures for the PDP 7.1\r\n\nWHO Technical Report Series, #961, Annex 13, 7.1 and 7.3\r\n\nWHO Technical Report Series, #986, Annex 2, 14.8\n\n\n15.4 The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\n\n\n\n21 CFR Part 211.196\r\n\n21 CFR Part 212.90\r\n\n21 CFR Part 225.110\r\n\n21 CFR Part 606.165\r\n\n29 CFR Part 1910.1450 Appendix A (I)\r\n\nA2LA C211 4.6\r\n\nASTM E1578-18 E-8-5\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5\n\n\n15.5 The system should provide a means for accurately recording the receipt, approval, distribution, and disposal of materials.\n\n\n\n21 CFR Part 211.82 (b)\r\n\n21 CFR Part 211.84 (a)\r\n\n21 CFR Part 211.89\r\n\n21 CFR Part 211.110 (d)\r\n\n21 CFR Part 211.142 (a)\r\n\n21 CFR Part 212.40 (c)\r\n\nASTM E1578-18 E-8-6\r\n\nWHO Technical Report Series, #986, Annex 2, 12.18\n\n\n15.6 The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\n\n\n\n21 CFR Part 211.89\r\n\n21 CFR Part 211.110 (d)\r\n\n42 CFR Part 493.1252 (d)\r\n\nASTM E1578-18 E-8-7\n\n\n15.7 The system should allow authorized personnel to retire faulty or poor quality materials from use.\n\n\n\n21 CFR Part 211.89\r\nASTM E1578-18 E-8-8\n\n\n15.8 The system shall clearly designate a standard or reagent as being disposed or consumed.\n\n\n\n16. Investigation and quality management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 312.62 (b)\r\n21 CFR Part 812.140 (a-3)\n\n16.1 The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\n\n\n\n21 CFR Part 312.57 (a)\r\n\n21 CFR Part 312.62 (a)\r\n\n21 CFR Part 606.165\r\n\n21 CFR Part 812.140 (a-2) and (b-2)\n\n\n16.2 The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\n\n\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 58.81 (a)\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.111\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 211.194\r\n\n21 CFR Part 606.171\r\n\n42 CFR Part 493.1253 (b-2)\r\n\nA2LA C211 5.4\r\n\nABFT Accreditation Manual C-16\r\n\nABFT Accreditation Manual F-2\r\n\nABFT Accreditation Manual J-3\r\n\nASTM E1578-18 E-9-1\r\n\nBRC GSFS, Issue 8, 5.6.2.3\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nCLSI QMS22 2.2.2.2\r\n\nEPA ERLN Laboratory Requirements 3.3\r\n\nEPA QA\/G-5 2.2.4\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\nISO\/IEC 17025:2017 7.2.1.7\r\n\nISO\/IEC 17025:2017 7.2.2.1\r\n\nISO\/IEC 17025:2017 7.10.2\r\n\nISO\/IEC 17025:2017 8.7.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 7.3\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)\r\n\nUSDA Administrative Procedures for the PDP 8.2.2\r\n\nWADA International Standard for Laboratories (ISL) 5.3.6\r\n\nWHO Technical Report Series, #986, Annex 2, 16.3\n\n\n16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\n\n\n42 CFR Part 493.1282\r\nASTM E1578-18 E-9-2\r\nE.U. Commission Reg. No. 2073\/2005 Article 9\n\n16.4 The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\n\n\n\n21 CFR Part 606.100 (c)\r\n\n42 CFR Part 493.1282\r\n\nASTM E1578-18 E-9-3\r\n\nCLSI QMS22 2.1.2.1\r\n\nCLSI QMS22 2.2.2.3\r\n\nEPA QA\/G-5 2.2.10\r\n\nWHO Technical Report Series, #986, Annex 2, 17.12\r\n\nWHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.5 The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\n\n\n\n10 CFR Part 30.34 (g)\r\n\n21 CFR Part 112.147\r\n\n21 CFR Part 225.58 (d)\r\n\n21 CFR Part 225.158\r\n\n21 CFR Part 606.100 (c)\r\n\n21 CFR Part 820.100\r\n\n42 CFR Part 493.1282\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nA2LA C211 4.9 and 4.11\r\n\nASTM E1578-18 E-9-4\r\n\nBRC GSFS, Issue 8, 3.4.3\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCLSI QMS22 2.6.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nFDA Hazard Analysis Critical Control Point Principle 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5, IR-5\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\nWADA International Standard for Laboratories (ISL) 5.3.9\r\n\nWHO Technical Report Series, #961, Annex 13, 11.1\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\r\n\nWHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\n\n\n\n21 CFR Part 225.58 (d)\r\n\n21 CFR Part 225.158\r\n\n42 CFR Part 493.1282\r\n\n42 CFR Part 493.1289\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nA2LA C211 4.8 and 4.11\r\n\nASTM E1578-18 E-9-5\r\n\nBRC GSFS, Issue 8, 3.4.3\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.3.4\r\n\nCJIS Security Policy Appendix G.7\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nFDA Hazard Analysis Critical Control Point Principle 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5, AU-6(1)\r\n\nNIST 800-53, Rev. 5, IR-4(1) and IR-5\r\n\nNIST 800-53, Rev. 5, SI-2 and SI-4\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\n\n\n16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\n\n\nASTM E1578-18 E-9-6\n\n16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\n\n\n9 CFR Part 2.35\n\n16.9 The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#14._Standard_and_reagent_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#14._Standard_and_reagent_management<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 2 May 2022, at 22:08.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2,552 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","9f172b7fc3c58eff808f985a33cdba7e_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Maintaining_Laboratory_Workflow_and_Operations rootpage-LII_LIMSpec_Maintaining_Laboratory_Workflow_and_Operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Maintaining Laboratory Workflow and Operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"7._Document_and_records_management\">7. Document and records management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/part-20\" target=\"_blank\">10 CFR Part 20 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.213\u201314<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(e) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.1<\/b> The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.214<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.300\" target=\"_blank\">42 CFR Part 93.300\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1773\" target=\"_blank\">42 CFR Part 493.1773 (c\u2013d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/160.310\" target=\"_blank\">45 CFR Part 160.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 Appendix H5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.2<\/b> The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.3<\/b> The system shall be able to clearly provide the most current version of a document and archive prior versions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.4<\/b> The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.91 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.14<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.5<\/b> The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-12, -14, and -15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.13<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.6<\/b> The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.10\" target=\"_blank\">7 CFR Part 331.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (j-3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.210\" target=\"_blank\">40 CFR Part 262.210\u201312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.7<\/b> The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.8<\/b> The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.9<\/b> The system shall support the addition of accurate cross-references and page numbers to new documents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.10<\/b> The system shall be capable of uniquely identifying documents created in and added to the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>7.11<\/b> The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"8._Resource_management\">8. Resource management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (m)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-3 and -4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.1<\/b> The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.198\" target=\"_blank\">21 CFR Part 820.198<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1233\" target=\"_blank\">42 CFR Part 493.1233<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.10.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.2<\/b> The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123<\/a> 21 CFR Part 123.10]<br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.3<\/b> The system shall allow training sessions and reviews to be scheduled for personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.4<\/b> The system should provide access to relevant training materials to personnel attending training sessions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2\u2013AT-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.5<\/b> The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.6<\/b> The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.7<\/b> The system should be able to produce a training matrix of personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (various parts)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.8<\/b> The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"9._Compliance_management\">9. Compliance management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.1<\/b> The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-2 and AU-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.2<\/b> The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3 and AU-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.3<\/b> The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.4<\/b> The system's audit trail shall document the previous and current value of a modified field.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.5<\/b> The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>9.6<\/b> The system shall prevent a user from copying and pasting the electronic signature of another user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6 and AU-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.7<\/b> The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"10._Instrument_and_equipment_management\">10. Instrument and equipment management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.1<\/b> The system should provide a means for tracking usage of laboratory equipment and instruments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.2<\/b> The system shall provide a means for planning the use of and reserving equipment and instruments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.3<\/b> The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.4<\/b> The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.5<\/b> The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.6<\/b> The system shall be able to group instruments together in specific ways, including by type and laboratory location.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.60\" target=\"_blank\">21 CFR Part 606.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (b-3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2 and MA-2(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.7<\/b> The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.8<\/b> The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.9<\/b> The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.10<\/b> The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.6.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.11<\/b> The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.12<\/b> The system shall support the use of predefined intervals when calculating instrument event dates.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.4 and 5.5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.13<\/b> The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-13<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.14<\/b> The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.63\" target=\"_blank\">21 CFR Part 58.63<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.182\" target=\"_blank\">21 CFR Part 211.182<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1254\" target=\"_blank\">42 CFR Part 493.1254<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20 and -23<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. F-1 and I-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.46<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.15<\/b> The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"11._Batch_and_lot_management\">11. Batch and lot management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.1<\/b> The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.2<\/b> The system shall maintain the links between component parts of a batch and track the batch throughout the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.65\" target=\"_blank\">21 CFR Part 820.65<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.3<\/b> The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>11.4<\/b> The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-15<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>11.5<\/b> The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"12._Scheduled_event_management\">12. Scheduled event management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.6\u20137<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.1<\/b> The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.2<\/b> The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.3<\/b> The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.4<\/b> The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.5<\/b> The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"13._Instrument_data_capture_and_control\">13. Instrument data capture and control<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.1<\/b> The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.2<\/b> The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.3<\/b> The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.4<\/b> The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.5<\/b> The system should be able to accept the results uploaded from an interfaced instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.6<\/b> The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.7<\/b> The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.8<\/b> The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"14._Standard_and_reagent_management\">14. Standard and reagent management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.83\" target=\"_blank\">21 CFR Part 58.83<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>14.1<\/b> The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.3\" target=\"_blank\">7 CFR Part 331.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.3\" target=\"_blank\">9 CFR Part 121.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.3\" target=\"_blank\">42 CFR Part 73.3\u20134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.20<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>14.2<\/b> The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.3<\/b> The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.4<\/b> The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.5<\/b> The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"15._Inventory_management\">15. Inventory management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>15.1<\/b> The system should be capable of accurately tracking the specific quantities of received and consumed test samples and specimens.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.2<\/b> The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (f-6) and (f-10)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.206\" target=\"_blank\">40 CFR Part 262.206<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.10\u201312<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.3<\/b> The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.50\" target=\"_blank\">21 CFR Part 820.50<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.4<\/b> The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.196\" target=\"_blank\">21 CFR Part 211.196<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.90\" target=\"_blank\">21 CFR Part 212.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 Appendix A (I)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.5<\/b> The system should provide a means for accurately recording the receipt, approval, distribution, and disposal of materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.82\" target=\"_blank\">21 CFR Part 211.82 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.142\" target=\"_blank\">21 CFR Part 211.142 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.6<\/b> The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.7<\/b> The system should allow authorized personnel to retire faulty or poor quality materials from use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.8<\/b> The system shall clearly designate a standard or reagent as being disposed or consumed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"16._Investigation_and_quality_management\">16. Investigation and quality management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.1<\/b> The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-2) and (b-2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.2<\/b> The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.81\" target=\"_blank\">21 CFR Part 58.81 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.171\" target=\"_blank\">21 CFR Part 606.171<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1253\" target=\"_blank\">42 CFR Part 493.1253 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual F-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual J-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.3<\/b> The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.4<\/b> The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.5<\/b> The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.147<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.100\" target=\"_blank\">21 CFR Part 820.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.9 and 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 11.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.6<\/b> The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1289\" target=\"_blank\">42 CFR Part 493.1289<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.8 and 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-4(1) and IR-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2 and SI-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.7<\/b> The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.8<\/b> The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.9<\/b> The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173541\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.104 seconds\nReal time usage: 0.111 seconds\nPreprocessor visited node count: 1035\/1000000\nPost\u2010expand include size: 141529\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 20.237 1 -total\n 11.99% 2.426 1 Template:LIMSpec\/Document_management\n 10.55% 2.135 1 Template:LIMSpec\/Resource_management\n 9.87% 1.998 1 Template:LIMSpec\/Instrument_and_equipment_management\n 9.68% 1.958 1 Template:LIMSpec\/Compliance_management\n 9.13% 1.848 1 Template:LIMSpec\/Batch_and_lot_management\n 9.07% 1.836 1 Template:LIMSpec\/Investigation_and_quality_management\n 8.97% 1.815 1 Template:LIMSpec\/Inventory_management\n 8.81% 1.782 1 Template:LIMSpec\/Scheduled_event_management\n 8.72% 1.764 1 Template:LIMSpec\/Instrument_data_capture_and_control\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11181-0!canonical and timestamp 20221202173541 and revision id 47569. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#14._Standard_and_reagent_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#14._Standard_and_reagent_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","9f172b7fc3c58eff808f985a33cdba7e_images":[],"9f172b7fc3c58eff808f985a33cdba7e_timestamp":1670002543,"c6dfe1e98f618e279fa954664ddfbb66_type":"article","c6dfe1e98f618e279fa954664ddfbb66_title":"13. Instrument data capture and control","c6dfe1e98f618e279fa954664ddfbb66_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#13._Instrument_data_capture_and_control","c6dfe1e98f618e279fa954664ddfbb66_plaintext":"\n\nLII:LIMSpec\/Maintaining Laboratory Workflow and OperationsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.\n\n7. Document and records management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n7 CFR Part 331 (throughout)\r\n\n9 CFR Part 121 (throughout)\r\n\n10 CFR Part 20 (throughout)\r\n\n21 CFR Part 7 (throughout)\r\n\n21 CFR Part 117 (throughout)\r\n\n21 CFR Part 58 (throughout)\r\n\n21 CFR Part 211 (throughout)\r\n\n21 CFR Part 212 (throughout)\r\n\n21 CFR Part 225 (throughout)\r\n\n21 CFR Part 226 (throughout)\r\n\n21 CFR Part 312 (throughout)\r\n\n21 CFR Part 606 (throughout)\r\n\n21 CFR Part 810 (throughout)\r\n\n21 CFR Part 812 (throughout)\r\n\n21 CFR Part 820 (throughout)\r\n\n29 CFR Part 1910.134 (throughout)\r\n\n29 CFR Part 1910.1030 (throughout)\r\n\n29 CFR Part 1910.1200 (throughout)\r\n\n29 CFR Part 1910.1450 (throughout)\r\n\n40 CFR Part 262.213\u201314\r\n\n42 CFR Part 73 (throughout)\r\n\n42 CFR Part 493.1200\r\n\n42 CFR Part 493.1232\r\n\n42 CFR Part 493.1239\r\n\n42 CFR Part 493.1251\r\n\n42 CFR Part 493.1291 (j)\r\n\n45 CFR Part 164 (throughout)\r\n\n61 FR 38806 (throughout)\r\n\nA2LA C211 4.3\r\n\nA2LA C223 4.13\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\nAAVLD Requirements for an AVMDL (throughout)\r\n\nABFT Accreditation Manual (throughout)\r\n\nASTM E1188-11 3.5.2\r\n\nASTM E1492-11 4.3.3.3 and 4.4.4\r\n\nASTM E1578-18 D-1-1\r\n\nBRC GSFS, Issue 8, 3.1.1\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nBRC GSFS, Issue 8, 5.6.1.1\r\n\nBRC GSFS, Issue 8, 5.6.2.2\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual (throughout)\r\n\nCJIS Security Policy (throughout)\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)\r\n\nEPA 815-R-05-004 (throughout)\r\n\nEPA ERLN Laboratory Requirements (throughout)\r\n\nEPA QA\/G-5 (throughout)\r\n\nE.U. Commission Directive 2003\/94\/EC (throughout)\r\n\nFDA Hazard Analysis Critical Control Point (throughout)\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\nIFS Food 7, Part 2 (throughout)\r\n\nIFS PACsecure 2, Part 2 (throughout)\r\n\nISO 15189:2012 4.3\r\n\nISO 15189:2012 5.5.3\r\n\nISO 15189:2012 5.9.3\r\n\nISO\/IEC 17025:2017 5.3\r\n\nISO\/IEC 17025:2017 5.5\r\n\nISO\/IEC 17025:2017 8.3.2\r\n\nISO\/TS 22002-1:2009 (throughout)\r\n\nISO\/TS 22002-4:2013 (throughout)\r\n\nISO\/TS 22002-6:2016 (throughout)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5 (throughout)\r\n\nOECD GLP Principles 8\r\n\nOSHA 1910.1200(b)(3)\r\n\nOSHA 1910.1450(e) and (h)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\nSQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nUSDA Data and Instrumentation for PDP (throughout)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\nWHO Technical Report Series, #961, Annex 13 (throughout)\r\n\nWHO Technical Report Series, #986, Annex 2 (throughout)\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\n\n\n\n7 CFR Part 331 (throughout)\r\n\n9 CFR Part 121 (throughout)\r\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 7 (throughout)\r\n\n21 CFR Part 58 (throughout)\r\n\n21 CFR Part 117 (throughout)\r\n\n21 CFR Part 211 (throughout)\r\n\n21 CFR Part 212 (throughout)\r\n\n21 CFR Part 225 (throughout)\r\n\n21 CFR Part 226 (throughout)\r\n\n21 CFR Part 312 (throughout)\r\n\n21 CFR Part 606 (throughout)\r\n\n21 CFR Part 810 (throughout)\r\n\n21 CFR Part 812 (throughout)\r\n\n21 CFR Part 820 (throughout)\r\n\n29 CFR Part 1910.134 (c)\r\n\n29 CFR Part 1910.1030 (throughout)\r\n\n29 CFR Part 1910.1200 (e)\r\n\n29 CFR Part 1910.1450 (throughout)\r\n\n40 CFR Part 262.214\r\n\n42 CFR Part 73 (throughout)\r\n\n42 CFR Part 93.300\u20135\r\n\n42 CFR Part 493.1200\r\n\n42 CFR Part 493.1232\r\n\n42 CFR Part 493.1239\r\n\n42 CFR Part 493.1251\r\n\n42 CFR Part 493.1291 (j)\r\n\n42 CFR Part 493.1773 (c\u2013d)\r\n\n45 CFR Part 160.310\r\n\n45 CFR Part 164 (throughout)\r\n\n61 FR 38806 (throughout)\r\n\nA2LA C211 (throughout)\r\n\nA2LA C223 (throughout)\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\nAAVLD Requirements for an AVMDL (throughout)\r\n\nACMG Technical Standards for Clinical Genetics Laboratories (throughout)\r\n\nAIHA-LAP Policies 2022 Appendix H5.8\r\n\nASTM E1188-11 3.5.2\r\n\nASTM E1492-11 4.3.3.3 and 4.4.4\r\n\nASTM E1578-18 D-1-2\r\n\nBRC GSFS, Issue 8, 3.1.2\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nBRC GSFS, Issue 8, 5.6.2.2\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual (throughout)\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)\r\n\nCJIS Security Policy (throughout)\r\n\nCLSI QMS22 (throughout)\r\n\nEPA 815-R-05-004 (throughout)\r\n\nEPA ERLN Laboratory Requirements (throughout)\r\n\nEPA QA\/G-5 (throughout)\r\n\nE.U. Commission Directive 2003\/94\/EC (throughout)\r\n\nFDA Hazard Analysis Critical Control Point (throughout)\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\nIFS Food 7, Part 2 (throughout)\r\n\nIFS PACsecure 2, Part 2 (throughout)\r\n\nISO 15189:2012 (throughout)\r\n\nISO\/IEC 17025:2017 (throughout)\r\n\nISO\/TS 22002-1:2009 (throughout)\r\n\nISO\/TS 22002-4:2013 (throughout)\r\n\nISO\/TS 22002-6:2016 (throughout)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5 (throughout)\r\n\nOECD GLP Principles 8\r\n\nOSHA 1910.1020 (throughout)\r\n\nOSHA 1910.1200(b)(3)\r\n\nOSHA 1910.1450(h)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\nSQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nUSDA Data and Instrumentation for PDP (throughout)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines (throughout)\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3\r\n\nUSDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\nWADA International Standard for Laboratories (ISL) (throughout)\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\r\n\nWHO Technical Report Series, #961, Annex 13 (throughout)\r\n\nWHO Technical Report Series, #986, Annex 2 (throughout)\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.2 The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\n\n\n\n21 CFR Part 1.1154 (c)\r\n\n21 CFR Part 820.40 (a)\r\n\n42 CFR Part 493.1251 (e)\r\n\nA2LA C211 4.3\r\n\nAAVLD Requirements for an AVMDL Sec. 4.3\r\n\nASTM E1578-18 D-1-3\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nEPA 815-R-05-004 Chap. III, Sec. 11\r\n\nEPA ERLN Laboratory Requirements 4.2.4.2\r\n\nEPA QA\/G-5 2.1.9\r\n\nISO 15189:2012 4.3\r\n\nISO 15189:2012 5.5.3\r\n\nISO 15189:2012 5.9.3\r\n\nISO\/IEC 17025:2017 7.5.2\r\n\nISO\/IEC 17025:2017 8.3.2\r\n\nUSDA Administrative Procedures for the PDP 5.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.5\n\n\n7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.\n\n\nASTM E1578-18 D-1-4\n\n7.4 The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1151\r\n\n21 CFR Part 1.1152 (e)\r\n\n21 CFR Part 106.91 (c)\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.315\r\n\n21 CFR Part 111.320\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.160\r\n\n21 CFR Part 212.20 (c)\r\n\n21 CFR Part 212.60 (c)\r\n\n21 CFR Part 226.58 (e)\r\n\n21 CFR Part 820.250 (b)\r\n\n42 CFR Part 493.43 (c)\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nASTM E1578-18 D-1-5\r\n\nBRC GSFS, Issue 8, 5.6.1.1\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.3\r\n\nCodex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\nCodex Alimentarius CXS 234-1999 (throughout)\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 5\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\nIFS Food 7, Part 2, 5.5.2\r\n\nIFS Food 7, Part 2, 5.6.2\r\n\nIFS PACsecure 2, Part 2, 5.5.2\r\n\nIFS PACsecure 2, Part 2, 5.6.2\r\n\nISO\/IEC 17025:2017 6.5\r\n\nISO\/IEC 17025:2017 7.2.1.3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)\r\n\nUSDA Administrative Procedures for the PDP 8.4\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1\r\n\nWHO Technical Report Series, #986, Annex 2, 15.14\n\n\n7.5 The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1151\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.320\r\n\n21 CFR Part 212.20 (c)\r\n\n21 CFR Part 212.70 (b)\r\n\nA2LA C211 5.4.5\r\n\nA2LA C223 5.4\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.4\r\n\nABFT Accreditation Manual Sec. G-12, -14, and -15\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C10\r\n\nACMG Technical Standards for Clinical Genetics Laboratories F7.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4\r\n\nCodex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\nCodex Alimentarius CXS 234-1999 (throughout)\r\n\nEPA QA\/G-5 2.2.4\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\nISO\/IEC 17025:2017 7.2.2.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\nUSDA Administrative Procedures for the PDP 8.4\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6\r\n\nWHO Technical Report Series, #961, Annex 13, 10.1\r\n\nWHO Technical Report Series, #986, Annex 2, 4.11\r\n\nWHO Technical Report Series, #986, Annex 2, 15.13\n\n\n7.6 The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\n\n\n\n7 CFR Part 331.10\r\n\n7 CFR Part 331.15\r\n\n9 CFR Part 2.32\r\n\n9 CFR Part 121.10 \r\n\n9 CFR Part 121.15 \r\n\n10 CFR Part 30.34 (j-3)\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 11.10 (i)\r\n\n21 CFR Part 58.29\r\n\n21 CFR Part 211.25\r\n\n21 CFR Part 225.10\r\n\n21 CFR Part 226.10\r\n\n21 CFR Part 226.40\r\n\n21 CFR Part 820.25\r\n\n29 CFR Part 1910.134 (c)\r\n\n29 CFR Part 1910.1030 (g-2)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n29 CFR Part 1910.1200 (h)\r\n\n29 CFR Part 1910.1450 (f)\r\n\n40 CFR Part 262.207\r\n\n40 CFR Part 262.210\u201312\r\n\n42 CFR Part 73.10\r\n\n42 CFR Part 73.15\r\n\n42 CFR Part 493.43 (c)\r\n\n42 CFR Part 493.1235\r\n\n42 CFR Part 493.1251\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 417.5\r\n\nA2LA C211 5.2\r\n\nA2LA C223 5.2\r\n\nA2LA C223 5.7\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\nAAVLD Requirements for an AVMDL Appendix 1\r\n\nABFT Accreditation Manual Sec. B\r\n\nACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.4\r\n\nAIHA-LAP Policies 2022 (throughout)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASTM E1578-18 C-3-5\r\n\nASTM E1578-18 D-1-6\r\n\nASTM E1578-18 E-1-6\r\n\nBRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nCAP Laboratory Accreditation Manual\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCLSI QMS22 (throughout)\r\n\nE.U. Annex 11-2\r\n\nE.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\nEPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 1\r\n\nEPA QA\/G-5 2.1.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.1\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.1\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nISO 15189:2012 4.1.2.1\r\n\nISO 15189:2012 5.1.6\r\n\nISO 15189:2012 5.1.9\r\n\nISO\/IEC 17025:2017 6.2.2\r\n\nISO\/IEC 17025:2017 6.2.3\r\n\nISO\/IEC 17025:2017 6.2.5\r\n\nISO\/IEC 17025:2017 6.2.6\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nOECD GLP Principles 1.1.2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\n\n\n7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n\n\nASTM E1578-18 D-1-7\n\n7.8 The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\n\n\nAAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5\r\nEPA ERLN Laboratory Requirements 4.10.6\n\n7.9 The system shall support the addition of accurate cross-references and page numbers to new documents.\n\n\nAAVLD Requirements for an AVMDL Sec. 4.3.4\n\n7.10 The system shall be capable of uniquely identifying documents created in and added to the system.\n\n\nAPHL 2019 LIS Project Management Guidebook\r\n\n\n7.11 The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\n\n\n\n8. Resource management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n9 CFR Part 2.32\r\n\n10 CFR Part 20.2103\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 110.10 (c)\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.10\r\n\n29 CFR Part 1910.120\r\n\n29 CFR Part 1910.134 (m)\r\n\n29 CFR Part 1910.1030 (h-1)\r\n\n29 CFR Part 1910.1450 (j)\r\n\n40 CFR Part 262.207\r\n\nA2LA C211 4.13.2.3\r\n\nA2LA C223 5.2\r\n\nA2LA C223 5.7\r\n\nACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nBRC GSFS, Issue 8, 7.3.1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.2.3\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nEPA QA\/G-5 2.1.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.1\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.1\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nNIST 800-53, Rev. 5, AT-3 and -4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOSHA 1910.1020 (throughout)\r\n\nOSHA 1910.1200(b)(3) and (h)\r\n\nOSHA 1910.1450 (throughout)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nUSDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\r\n\nWHO Technical Report Series, #996, Annex 5, 8.1\n\n\n8.1 The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\n\n\n\n21 CFR Part 820.198\r\n\n42 CFR Part 493.1233\r\n\nBRC GSFS, Issue 8, 3.10.1\u20132\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21\r\n\nIFS Food 7, Part 2, 5.8\r\n\nIFS PACsecure 2, Part 2, 5.8\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)\r\n\nWADA International Standard for Laboratories (ISL) 5.3.10\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\n\n\n8.2 The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.\n\n\n\n5 CFR Part 930.301\r\n\n7 CFR Part 331.15\r\n\n9 CFR Part 121.15\r\n\n21 CFR Part 120.12\r\n\nhttps:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123 21 CFR Part 123.10]\r\n\n21 CFR Part 211.25\r\n\n29 CFR Part 1910.1450 (f)\r\n\n42 CFR Part 73.15\r\n\nA2LA C223 5.2\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3\r\n\nASTM E1578-18 E-1-1\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nCJIS Security Policy 5.2.1\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nNIST 800-53, Rev. 5, AT-2 and AT-3\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Sampling Procedures for PDP 6.1.2\u20133\r\n\nWHO Technical Report Series, #986, Annex 2, 10\n\n\n8.3 The system shall allow training sessions and reviews to be scheduled for personnel.\n\n\n\n5 CFR Part 930.301\r\n\n29 CFR Part 1910.1450 (f)\r\n\nABFT Accreditation Manual Sec. B\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7\r\n\nASTM E1578-18 E-1-2\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.4 The system should provide access to relevant training materials to personnel attending training sessions.\n\n\n\n5 CFR Part 930.301\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 110.10 (c)\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.10\r\n\n29 CFR Part 1910.1450 (f)\r\n\n40 CFR Part 262.207\r\n\nA2LA C223 5.2\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5\r\n\nASTM E1578-18 E-1-3\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.2.3\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nEPA QA\/G-5 2.1.8\r\n\nE.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nISO 15189:2012 5.1.9\r\n\nNIST 800-53, Rev. 5, AT-2\u2013AT-4\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e\r\n\nUSDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (e)\r\n\nWHO Technical Report Series, #986, Annex 2, 9.4\r\n\nWHO Technical Report Series, #986, Annex 2, 10\n\n\n8.5 The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\n\n\n\nABFT Accreditation Manual Sec. B\r\n\nASTM E1578-18 E-1-4\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\n\n\n8.6 The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\n\n\n\nASTM E1578-18 E-1-5\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nNIST 800-53, Rev. 5, AT-2 and AT-3\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.7 The system should be able to produce a training matrix of personnel.\n\n\n\n7 CFR Part 331.15\r\n\n9 CFR Part 121.10 \r\n\n9 CFR Part 121.15 \r\n\n21 CFR Part 11.10 (i)\r\n\n21 CFR Part 58.29\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 211.25\r\n\n21 CFR Part 225.10\r\n\n21 CFR Part 226.10\r\n\n21 CFR Part 226.40\r\n\n21 CFR Part 820.25\r\n\n29 CFR Part 1910.1030 (g-2)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n29 CFR Part 1910.1200 (h)\r\n\n29 CFR Part 1910.1450 (e)\r\n\n42 CFR Part 73.10\r\n\n42 CFR Part 73.15\r\n\n42 CFR Part 493.43 (c)\r\n\n42 CFR Part 493.1235\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nA2LA C223 5.2\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\nAAVLD Requirements for an AVMDL Appendix 1\r\n\nABFT Accreditation Manual Sec. B\r\n\nAIHA-LAP Policies 2022 (various parts)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASTM E1578-18 C-3-5\r\n\nASTM E1578-18 D-1-6\r\n\nASTM E1578-18 E-1-6\r\n\nBRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nE.U. Annex 11-2\r\n\nEPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 1\r\n\nEPA QA\/G-5 2.1.8\r\n\nISO 15189:2012 4.1.2.1\r\n\nISO 15189:2012 5.1.6\r\n\nISO 15189:2012 5.1.9\r\n\nISO\/IEC 17025:2017 6.2.2\r\n\nISO\/IEC 17025:2017 6.2.3\r\n\nISO\/IEC 17025:2017 6.2.5\r\n\nISO\/IEC 17025:2017 6.2.6\r\n\nOECD GLP Principles 1.1.2\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\n\n\n8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n\n\n\n9. Compliance management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17 \r\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1251 (d)\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nASTM E1578-18 C-4-7\r\n\nASTM E1578-18 E-2-1\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Annex 11-9\r\n\nE.U. Annex 11-14\r\n\nOECD GLP Principles 8.3.5\r\n\nUSDA Data and Instrumentation for PDP 8.1.3\n\n\n9.1 The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-2\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCJIS Security Policy Appendix G.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Annex 11-9\r\n\nE.U. Annex 11-12.4\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nNIST 800-53, Rev. 5, AC-2(4) and AC-6(9)\r\n\nNIST 800-53, Rev. 5, AU-2 and AU-3\r\n\nNIST 800-53, Rev. 5, CM-5(1)\r\n\nOECD GLP Principles 8.3.5\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n9.2 The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1274\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-3\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCLSI QMS22 2.2.3.2\r\n\nCLSI QMS22 2.4.3\r\n\nE.U. Annex 11-12.4\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nNIST 800-53, Rev. 5, AU-3 and AU-8\r\n\nOECD GLP Principles 8.3.5\r\n\nUSDA Data and Instrumentation for PDP 8.1.4\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.3 The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-4\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nICH GCP 4.9.0 and 4.9.3\r\n\nNIST 800-53, Rev. 5, AU-3\r\n\nOECD GLP Principles 8.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.4 The system's audit trail shall document the previous and current value of a modified field.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1251 (d)\r\n\n45 CFR Part 164.310\r\n\nASTM E1578-18 E-2-5\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nE.U. Annex 11-14\r\n\nOECD GLP Principles 8.3.5\n\n\n9.5 The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\n\n\n21 CFR Part 11.70\r\nE.U. Annex 11-14\n\n9.6 The system shall prevent a user from copying and pasting the electronic signature of another user.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 58.130 (e)\r\n\n42 CFR Part 493.1274 (d)\r\n\nE.U. Annex 11-9\r\n\nNIST 800-53, Rev. 5, AU-6 and AU-12\r\n\nOECD GLP Principles 8.3.5\n\n\n9.7 The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\n\n\n\n10. Instrument and equipment management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-3-1\n\n10.1 The system should provide a means for tracking usage of laboratory equipment and instruments.\n\n\nASTM E1578-18 E-3-2\n\n10.2 The system shall provide a means for planning the use of and reserving equipment and instruments.\n\n\nASTM E1578-18 E-3-3\n\n10.3 The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\n\n\nASTM E1578-18 E-3-4\n\n10.4 The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\n\n\nASTM E1578-18 E-3-5\n\n10.5 The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\n\n\nASTM E1578-18 E-3-6\n\n10.6 The system shall be able to group instruments together in specific ways, including by type and laboratory location.\n\n\n\n21 CFR Part 110.40 (f)\r\n\n21 CFR Part 211.67\u201368\r\n\n21 CFR Part 211.160 (b-4)\r\n\n21 CFR Part 212.30 (b)\r\n\n21 CFR Part 212.60 (e)\r\n\n21 CFR Part 225.30 (b-4)\r\n\n21 CFR Part 606.60\r\n\n21 CFR Part 820.70 (g)\r\n\n21 CFR Part 820.72\r\n\n42 CFR Part 493.1252 (b-3)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.5.2\r\n\nA2LA C223 5.5\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5\r\n\nABFT Accreditation Manual Sec. E-20\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1\r\n\nAIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\nASTM E1578-18 E-3-7\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.6.1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nISO 15189:2012 5.3.1.4\r\n\nISO\/IEC 17025:2017 6.4.7\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nISO\/TS 22002-4:2013, 4.7.1\r\n\nISO\/TS 22002-6:2016, 4.7\r\n\nNIST 800-53, Rev. 5, MA-2 and MA-2(2)\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Data and Instrumentation for PDP 5.2\r\n\nUSDA Data and Instrumentation for PDP 6\r\n\nWADA International Standard for Laboratories (ISL) 5.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 13.5\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\n\n\n\n21 CFR Part 225.30 (b-4)\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5.9\r\n\nASTM E1578-18 E-3-8\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.8 The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\n\n\n\n21 CFR Part 211.160 (b-4)\r\n\nA2LA C211 5.5.7\r\n\nA2LA C223 5.6\r\n\nABFT Accreditation Manual Sec. E-21\r\n\nASTM E1578-18 E-3-9\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nCLSI QMS22 2.1.2.1\r\n\nIFS Food 7, Part 2, 5.4.3\r\n\nIFS PACsecure 2, Part 2, 5.4.3\r\n\nISO 15189:2012 5.3.1.5\r\n\nISO\/IEC 17025:2017 6.4.9\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)\r\n\nWHO Technical Report Series, #986, Annex 2, 13.10\n\n\n10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.\n\n\n\n21 CFR Part 111.117\r\n\n21 CFR Part 820.72 (b-2)\r\n\nASTM E1578-18 E-3-10\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nNIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\n\n\n\n21 CFR Part 820.72 (b-1)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.6.2.1\r\n\nA2LA C223 5.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.6.1\u20132\r\n\nAIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nISO\/IEC 17025:2017 6.5\r\n\nISO\/TS 22002-4:2013, 4.7.1\r\n\nISO\/TS 22002-6:2016, 4.7\r\n\nOECD GLP Principles 4.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.2\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)\r\n\nUSDA Data and Instrumentation for PDP 6.1\n\n\n10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\n\n\nASTM E1578-18 E-3-11\n\n10.12 The system shall support the use of predefined intervals when calculating instrument event dates.\n\n\n\n21 CFR Part 110.40 (f)\r\n\n21 CFR Part 211.105 (b)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.5.4 and 5.5.5\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5.4\u20135\r\n\nASTM E1578-18 E-3-12\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1\r\n\nIFS Food 7, Part 2, 5.4.1\r\n\nIFS PACsecure 2, Part 2, 5.4.1\r\n\nISO 15189:2012 5.3.1.7\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nISO\/IEC 17025:2017 6.4.13\r\n\nNIST 800-53, Rev. 5, CM-8\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\nUSDA Administrative Procedures for the PDP 7.2\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4\r\n\nWHO Technical Report Series, #961, Annex 13, 6.1\n\n\n10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\n\n\nASTM E1578-18 E-3-13\n\n10.14 The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\n\n\n\n10 CFR Part 20.2103\r\n\n21 CFR Part 58.63\r\n\n21 CFR Part 111.117\r\n\n21 CFR Part 211.67\u201368\r\n\n21 CFR Part 211.160 (b-4)\r\n\n21 CFR Part 211.182\r\n\n21 CFR Part 211.194 (d)\r\n\n21 CFR Part 212.30 (b)\r\n\n21 CFR Part 212.60 (e)\r\n\n21 CFR Part 820.70 (g)\r\n\n21 CFR Part 820.72\r\n\n42 CFR Part 493.1254\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 4.13.2.1\r\n\nA2LA C211 5.5.2\r\n\nA2LA C211 5.10.4\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5\r\n\nABFT Accreditation Manual Sec. E-20 and -23\r\n\nABFT Accreditation Manual Sec. F-1 and I-1\r\n\nAIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\nASTM E1578-18 E-3-14\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.2.1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nISO 15189:2012 5.3.1.4\r\n\nISO\/IEC 17025:2017 6.4.4\r\n\nNIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 4.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Data and Instrumentation for PDP 5.4\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c\r\n\nWADA International Standard for Laboratories (ISL) 5.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 15.46\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.15 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\n\n\n\n11. Batch and lot management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 58.105 (a)\r\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nASTM E1578-18 E-4-1\r\n\nEPA ERLN Laboratory Requirements 3.3\r\n\nEPA ERLN Laboratory Requirements 4.10.1\r\n\nOECD GLP Principles 6.2\n\n\n11.1 The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\n\n\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nASTM E1578-18 E-4-2\r\n\nEPA ERLN Laboratory Requirements 4.10.1\n\n\n11.2 The system shall maintain the links between component parts of a batch and track the batch throughout the system.\n\n\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 820.65\r\n\nASTM E1578-18 E-4-3\n\n\n11.3 The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\n\n\nASTM E1578-18 E-4-4\n\n11.4 The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\n\n\nE.U. Annex 11-15\n\n11.5 The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\n\n\n\n12. Scheduled event management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 129.80 (g)\r\nASTM E1578-18 E-5-1\r\nUSDA Sampling Procedures for PDP 5.6\u20137\n\n12.1 The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.\n\n\n21 CFR Part 212.61 (a)\r\n21 CFR Part 211.166 (b)\r\nASTM E1578-18 E-5-2\n\n12.2 The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.\n\n\nASTM E1578-18 E-5-3\n\n12.3 The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\n\n\nASTM E1578-18 E-5-4\n\n12.4 The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).\n\n\nASTM E1578-18 E-5-5\n\n12.5 The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\n\n\n\n13. Instrument data capture and control \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-6-1\n\n13.1 The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\n\n\nASTM E1578-18 E-6-2\n\n13.2 The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\n\n\nASTM E1578-18 E-6-3\n\n13.3 The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\n\n\nASTM E1578-18 E-6-4\n\n13.4 The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\n\n\nASTM E1578-18 E-6-5\n\n13.5 The system should be able to accept the results uploaded from an interfaced instrument.\n\n\nASTM E1578-18 E-6-6\n\n13.6 The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\n\n\nASTM E1578-18 E-6-7\n\n13.7 The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\n\n\nASTM E1578-18 E-6-8\n\n13.8 The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\n\n\n\n14. Standard and reagent management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 58.83\r\n\n29 CFR Part 1910.1200 (g)\r\n\n29 CFR Part 1910.1450 (h)\r\n\n42 CFR Part 493.1252 (c)\r\n\nABFT Accreditation Manual Sec. E-17\r\n\nASTM E1578-18 E-7-1\r\n\nISO 15189:2012 5.3.2.4\u20135\r\n\nOECD GLP Principles 4.4\n\n\n14.1 The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\n\n\n\n7 CFR Part 331.3\r\n\n9 CFR Part 121.3\r\n\n21 CFR Part 312.58 (b)\r\n\n42 CFR Part 73.3\u20134 (c)\r\n\nASTM E1578-18 E-7-2\r\n\nEPA ERLN Laboratory Requirements 4.1.12\r\n\nISO 15189:2012 5.3.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 12.20\n\n\n14.2 The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\n\n\nASTM E1578-18 E-7-3\r\nISO 15189:2012 5.3.2.4\n\n14.3 The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\n\n\nASTM E1578-18 E-7-4\r\nISO 15189:2012 5.3.2.4\n\n14.4 The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\n\n\nASTM E1578-18 E-7-5\r\nISO 15189:2012 5.3.2.4\n\n14.5 The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\n\n\n\n15. Inventory management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-8-1\r\nCAP Laboratory Accreditation Manual\r\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples and specimens.\n\n\n\n21 CFR Part 212.60 (d)\r\n\nASTM E1578-18 E-8-2\r\n\nCLSI QMS22 2.1.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.2 The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\n\n\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.101\r\n\n21 CFR Part 212.60 (d)\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 606.120 (b)\r\n\n29 CFR Part 1910.1030 (g)\r\n\n29 CFR Part 1910.1096 (e-6)\r\n\n29 CFR Part 1910.1200 (f-6) and (f-10)\r\n\n40 CFR Part 262.206\r\n\nASTM E1578-18 E-8-3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOSHA 1910.1200(b)(3) and (f)\r\n\nOSHA 1910.1450(h)\r\n\nWHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41\r\n\nWHO Technical Report Series, #986, Annex 2, 15.10\u201312\n\n\n15.3 The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\n\n\n\n21 CFR Part 117.420\r\n\n21 CFR Part 212.40 (c)\r\n\n21 CFR Part 820.50\r\n\nA2LA C211 4.6\r\n\nASTM E1578-18 E-8-4\r\n\nBRC GSFS, Issue 8, 3.5.1.4\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5\r\n\nIFS Food 7, Part 2, 4.4.1\r\n\nIFS PACsecure 2, Part 2, 4.4.1\r\n\nISO\/TS 22002-1:2009, 9.2\r\n\nISO\/TS 22002-4:2013, 4.6.2\r\n\nISO\/TS 22002-6:2016, 4.6.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.4.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)\r\n\nUSDA Administrative Procedures for the PDP 7.1\r\n\nWHO Technical Report Series, #961, Annex 13, 7.1 and 7.3\r\n\nWHO Technical Report Series, #986, Annex 2, 14.8\n\n\n15.4 The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\n\n\n\n21 CFR Part 211.196\r\n\n21 CFR Part 212.90\r\n\n21 CFR Part 225.110\r\n\n21 CFR Part 606.165\r\n\n29 CFR Part 1910.1450 Appendix A (I)\r\n\nA2LA C211 4.6\r\n\nASTM E1578-18 E-8-5\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5\n\n\n15.5 The system should provide a means for accurately recording the receipt, approval, distribution, and disposal of materials.\n\n\n\n21 CFR Part 211.82 (b)\r\n\n21 CFR Part 211.84 (a)\r\n\n21 CFR Part 211.89\r\n\n21 CFR Part 211.110 (d)\r\n\n21 CFR Part 211.142 (a)\r\n\n21 CFR Part 212.40 (c)\r\n\nASTM E1578-18 E-8-6\r\n\nWHO Technical Report Series, #986, Annex 2, 12.18\n\n\n15.6 The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\n\n\n\n21 CFR Part 211.89\r\n\n21 CFR Part 211.110 (d)\r\n\n42 CFR Part 493.1252 (d)\r\n\nASTM E1578-18 E-8-7\n\n\n15.7 The system should allow authorized personnel to retire faulty or poor quality materials from use.\n\n\n\n21 CFR Part 211.89\r\nASTM E1578-18 E-8-8\n\n\n15.8 The system shall clearly designate a standard or reagent as being disposed or consumed.\n\n\n\n16. Investigation and quality management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 312.62 (b)\r\n21 CFR Part 812.140 (a-3)\n\n16.1 The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\n\n\n\n21 CFR Part 312.57 (a)\r\n\n21 CFR Part 312.62 (a)\r\n\n21 CFR Part 606.165\r\n\n21 CFR Part 812.140 (a-2) and (b-2)\n\n\n16.2 The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\n\n\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 58.81 (a)\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.111\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 211.194\r\n\n21 CFR Part 606.171\r\n\n42 CFR Part 493.1253 (b-2)\r\n\nA2LA C211 5.4\r\n\nABFT Accreditation Manual C-16\r\n\nABFT Accreditation Manual F-2\r\n\nABFT Accreditation Manual J-3\r\n\nASTM E1578-18 E-9-1\r\n\nBRC GSFS, Issue 8, 5.6.2.3\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nCLSI QMS22 2.2.2.2\r\n\nEPA ERLN Laboratory Requirements 3.3\r\n\nEPA QA\/G-5 2.2.4\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\nISO\/IEC 17025:2017 7.2.1.7\r\n\nISO\/IEC 17025:2017 7.2.2.1\r\n\nISO\/IEC 17025:2017 7.10.2\r\n\nISO\/IEC 17025:2017 8.7.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 7.3\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)\r\n\nUSDA Administrative Procedures for the PDP 8.2.2\r\n\nWADA International Standard for Laboratories (ISL) 5.3.6\r\n\nWHO Technical Report Series, #986, Annex 2, 16.3\n\n\n16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\n\n\n42 CFR Part 493.1282\r\nASTM E1578-18 E-9-2\r\nE.U. Commission Reg. No. 2073\/2005 Article 9\n\n16.4 The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\n\n\n\n21 CFR Part 606.100 (c)\r\n\n42 CFR Part 493.1282\r\n\nASTM E1578-18 E-9-3\r\n\nCLSI QMS22 2.1.2.1\r\n\nCLSI QMS22 2.2.2.3\r\n\nEPA QA\/G-5 2.2.10\r\n\nWHO Technical Report Series, #986, Annex 2, 17.12\r\n\nWHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.5 The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\n\n\n\n10 CFR Part 30.34 (g)\r\n\n21 CFR Part 112.147\r\n\n21 CFR Part 225.58 (d)\r\n\n21 CFR Part 225.158\r\n\n21 CFR Part 606.100 (c)\r\n\n21 CFR Part 820.100\r\n\n42 CFR Part 493.1282\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nA2LA C211 4.9 and 4.11\r\n\nASTM E1578-18 E-9-4\r\n\nBRC GSFS, Issue 8, 3.4.3\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCLSI QMS22 2.6.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nFDA Hazard Analysis Critical Control Point Principle 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5, IR-5\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\nWADA International Standard for Laboratories (ISL) 5.3.9\r\n\nWHO Technical Report Series, #961, Annex 13, 11.1\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\r\n\nWHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\n\n\n\n21 CFR Part 225.58 (d)\r\n\n21 CFR Part 225.158\r\n\n42 CFR Part 493.1282\r\n\n42 CFR Part 493.1289\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nA2LA C211 4.8 and 4.11\r\n\nASTM E1578-18 E-9-5\r\n\nBRC GSFS, Issue 8, 3.4.3\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.3.4\r\n\nCJIS Security Policy Appendix G.7\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nFDA Hazard Analysis Critical Control Point Principle 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5, AU-6(1)\r\n\nNIST 800-53, Rev. 5, IR-4(1) and IR-5\r\n\nNIST 800-53, Rev. 5, SI-2 and SI-4\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\n\n\n16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\n\n\nASTM E1578-18 E-9-6\n\n16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\n\n\n9 CFR Part 2.35\n\n16.9 The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#13._Instrument_data_capture_and_control\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#13._Instrument_data_capture_and_control<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 2 May 2022, at 22:08.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2,552 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","c6dfe1e98f618e279fa954664ddfbb66_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Maintaining_Laboratory_Workflow_and_Operations rootpage-LII_LIMSpec_Maintaining_Laboratory_Workflow_and_Operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Maintaining Laboratory Workflow and Operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"7._Document_and_records_management\">7. Document and records management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/part-20\" target=\"_blank\">10 CFR Part 20 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.213\u201314<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(e) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.1<\/b> The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.214<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.300\" target=\"_blank\">42 CFR Part 93.300\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1773\" target=\"_blank\">42 CFR Part 493.1773 (c\u2013d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/160.310\" target=\"_blank\">45 CFR Part 160.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 Appendix H5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.2<\/b> The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.3<\/b> The system shall be able to clearly provide the most current version of a document and archive prior versions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.4<\/b> The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.91 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.14<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.5<\/b> The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-12, -14, and -15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.13<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.6<\/b> The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.10\" target=\"_blank\">7 CFR Part 331.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (j-3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.210\" target=\"_blank\">40 CFR Part 262.210\u201312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.7<\/b> The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.8<\/b> The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.9<\/b> The system shall support the addition of accurate cross-references and page numbers to new documents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.10<\/b> The system shall be capable of uniquely identifying documents created in and added to the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>7.11<\/b> The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"8._Resource_management\">8. Resource management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (m)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-3 and -4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.1<\/b> The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.198\" target=\"_blank\">21 CFR Part 820.198<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1233\" target=\"_blank\">42 CFR Part 493.1233<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.10.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.2<\/b> The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123<\/a> 21 CFR Part 123.10]<br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.3<\/b> The system shall allow training sessions and reviews to be scheduled for personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.4<\/b> The system should provide access to relevant training materials to personnel attending training sessions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2\u2013AT-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.5<\/b> The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.6<\/b> The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.7<\/b> The system should be able to produce a training matrix of personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (various parts)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.8<\/b> The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"9._Compliance_management\">9. Compliance management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.1<\/b> The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-2 and AU-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.2<\/b> The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3 and AU-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.3<\/b> The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.4<\/b> The system's audit trail shall document the previous and current value of a modified field.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.5<\/b> The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>9.6<\/b> The system shall prevent a user from copying and pasting the electronic signature of another user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6 and AU-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.7<\/b> The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"10._Instrument_and_equipment_management\">10. Instrument and equipment management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.1<\/b> The system should provide a means for tracking usage of laboratory equipment and instruments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.2<\/b> The system shall provide a means for planning the use of and reserving equipment and instruments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.3<\/b> The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.4<\/b> The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.5<\/b> The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.6<\/b> The system shall be able to group instruments together in specific ways, including by type and laboratory location.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.60\" target=\"_blank\">21 CFR Part 606.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (b-3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2 and MA-2(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.7<\/b> The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.8<\/b> The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.9<\/b> The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.10<\/b> The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.6.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.11<\/b> The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.12<\/b> The system shall support the use of predefined intervals when calculating instrument event dates.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.4 and 5.5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.13<\/b> The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-13<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.14<\/b> The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.63\" target=\"_blank\">21 CFR Part 58.63<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.182\" target=\"_blank\">21 CFR Part 211.182<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1254\" target=\"_blank\">42 CFR Part 493.1254<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20 and -23<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. F-1 and I-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.46<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.15<\/b> The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"11._Batch_and_lot_management\">11. Batch and lot management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.1<\/b> The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.2<\/b> The system shall maintain the links between component parts of a batch and track the batch throughout the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.65\" target=\"_blank\">21 CFR Part 820.65<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.3<\/b> The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>11.4<\/b> The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-15<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>11.5<\/b> The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"12._Scheduled_event_management\">12. Scheduled event management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.6\u20137<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.1<\/b> The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.2<\/b> The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.3<\/b> The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.4<\/b> The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.5<\/b> The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"13._Instrument_data_capture_and_control\">13. Instrument data capture and control<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.1<\/b> The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.2<\/b> The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.3<\/b> The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.4<\/b> The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.5<\/b> The system should be able to accept the results uploaded from an interfaced instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.6<\/b> The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.7<\/b> The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.8<\/b> The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"14._Standard_and_reagent_management\">14. Standard and reagent management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.83\" target=\"_blank\">21 CFR Part 58.83<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>14.1<\/b> The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.3\" target=\"_blank\">7 CFR Part 331.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.3\" target=\"_blank\">9 CFR Part 121.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.3\" target=\"_blank\">42 CFR Part 73.3\u20134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.20<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>14.2<\/b> The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.3<\/b> The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.4<\/b> The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.5<\/b> The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"15._Inventory_management\">15. Inventory management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>15.1<\/b> The system should be capable of accurately tracking the specific quantities of received and consumed test samples and specimens.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.2<\/b> The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (f-6) and (f-10)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.206\" target=\"_blank\">40 CFR Part 262.206<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.10\u201312<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.3<\/b> The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.50\" target=\"_blank\">21 CFR Part 820.50<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.4<\/b> The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.196\" target=\"_blank\">21 CFR Part 211.196<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.90\" target=\"_blank\">21 CFR Part 212.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 Appendix A (I)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.5<\/b> The system should provide a means for accurately recording the receipt, approval, distribution, and disposal of materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.82\" target=\"_blank\">21 CFR Part 211.82 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.142\" target=\"_blank\">21 CFR Part 211.142 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.6<\/b> The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.7<\/b> The system should allow authorized personnel to retire faulty or poor quality materials from use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.8<\/b> The system shall clearly designate a standard or reagent as being disposed or consumed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"16._Investigation_and_quality_management\">16. Investigation and quality management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.1<\/b> The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-2) and (b-2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.2<\/b> The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.81\" target=\"_blank\">21 CFR Part 58.81 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.171\" target=\"_blank\">21 CFR Part 606.171<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1253\" target=\"_blank\">42 CFR Part 493.1253 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual F-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual J-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.3<\/b> The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.4<\/b> The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.5<\/b> The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.147<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.100\" target=\"_blank\">21 CFR Part 820.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.9 and 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 11.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.6<\/b> The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1289\" target=\"_blank\">42 CFR Part 493.1289<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.8 and 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-4(1) and IR-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2 and SI-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.7<\/b> The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.8<\/b> The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.9<\/b> The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173541\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.104 seconds\nReal time usage: 0.111 seconds\nPreprocessor visited node count: 1035\/1000000\nPost\u2010expand include size: 141529\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 20.237 1 -total\n 11.99% 2.426 1 Template:LIMSpec\/Document_management\n 10.55% 2.135 1 Template:LIMSpec\/Resource_management\n 9.87% 1.998 1 Template:LIMSpec\/Instrument_and_equipment_management\n 9.68% 1.958 1 Template:LIMSpec\/Compliance_management\n 9.13% 1.848 1 Template:LIMSpec\/Batch_and_lot_management\n 9.07% 1.836 1 Template:LIMSpec\/Investigation_and_quality_management\n 8.97% 1.815 1 Template:LIMSpec\/Inventory_management\n 8.81% 1.782 1 Template:LIMSpec\/Scheduled_event_management\n 8.72% 1.764 1 Template:LIMSpec\/Instrument_data_capture_and_control\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11181-0!canonical and timestamp 20221202173541 and revision id 47569. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#13._Instrument_data_capture_and_control\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#13._Instrument_data_capture_and_control<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","c6dfe1e98f618e279fa954664ddfbb66_images":[],"c6dfe1e98f618e279fa954664ddfbb66_timestamp":1670002542,"e65f4869b4cef313b97d330551ce3dde_type":"article","e65f4869b4cef313b97d330551ce3dde_title":"12. Scheduled event management","e65f4869b4cef313b97d330551ce3dde_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#12._Scheduled_event_management","e65f4869b4cef313b97d330551ce3dde_plaintext":"\n\nLII:LIMSpec\/Maintaining Laboratory Workflow and OperationsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.\n\n7. Document and records management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n7 CFR Part 331 (throughout)\r\n\n9 CFR Part 121 (throughout)\r\n\n10 CFR Part 20 (throughout)\r\n\n21 CFR Part 7 (throughout)\r\n\n21 CFR Part 117 (throughout)\r\n\n21 CFR Part 58 (throughout)\r\n\n21 CFR Part 211 (throughout)\r\n\n21 CFR Part 212 (throughout)\r\n\n21 CFR Part 225 (throughout)\r\n\n21 CFR Part 226 (throughout)\r\n\n21 CFR Part 312 (throughout)\r\n\n21 CFR Part 606 (throughout)\r\n\n21 CFR Part 810 (throughout)\r\n\n21 CFR Part 812 (throughout)\r\n\n21 CFR Part 820 (throughout)\r\n\n29 CFR Part 1910.134 (throughout)\r\n\n29 CFR Part 1910.1030 (throughout)\r\n\n29 CFR Part 1910.1200 (throughout)\r\n\n29 CFR Part 1910.1450 (throughout)\r\n\n40 CFR Part 262.213\u201314\r\n\n42 CFR Part 73 (throughout)\r\n\n42 CFR Part 493.1200\r\n\n42 CFR Part 493.1232\r\n\n42 CFR Part 493.1239\r\n\n42 CFR Part 493.1251\r\n\n42 CFR Part 493.1291 (j)\r\n\n45 CFR Part 164 (throughout)\r\n\n61 FR 38806 (throughout)\r\n\nA2LA C211 4.3\r\n\nA2LA C223 4.13\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\nAAVLD Requirements for an AVMDL (throughout)\r\n\nABFT Accreditation Manual (throughout)\r\n\nASTM E1188-11 3.5.2\r\n\nASTM E1492-11 4.3.3.3 and 4.4.4\r\n\nASTM E1578-18 D-1-1\r\n\nBRC GSFS, Issue 8, 3.1.1\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nBRC GSFS, Issue 8, 5.6.1.1\r\n\nBRC GSFS, Issue 8, 5.6.2.2\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual (throughout)\r\n\nCJIS Security Policy (throughout)\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)\r\n\nEPA 815-R-05-004 (throughout)\r\n\nEPA ERLN Laboratory Requirements (throughout)\r\n\nEPA QA\/G-5 (throughout)\r\n\nE.U. Commission Directive 2003\/94\/EC (throughout)\r\n\nFDA Hazard Analysis Critical Control Point (throughout)\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\nIFS Food 7, Part 2 (throughout)\r\n\nIFS PACsecure 2, Part 2 (throughout)\r\n\nISO 15189:2012 4.3\r\n\nISO 15189:2012 5.5.3\r\n\nISO 15189:2012 5.9.3\r\n\nISO\/IEC 17025:2017 5.3\r\n\nISO\/IEC 17025:2017 5.5\r\n\nISO\/IEC 17025:2017 8.3.2\r\n\nISO\/TS 22002-1:2009 (throughout)\r\n\nISO\/TS 22002-4:2013 (throughout)\r\n\nISO\/TS 22002-6:2016 (throughout)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5 (throughout)\r\n\nOECD GLP Principles 8\r\n\nOSHA 1910.1200(b)(3)\r\n\nOSHA 1910.1450(e) and (h)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\nSQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nUSDA Data and Instrumentation for PDP (throughout)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\nWHO Technical Report Series, #961, Annex 13 (throughout)\r\n\nWHO Technical Report Series, #986, Annex 2 (throughout)\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\n\n\n\n7 CFR Part 331 (throughout)\r\n\n9 CFR Part 121 (throughout)\r\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 7 (throughout)\r\n\n21 CFR Part 58 (throughout)\r\n\n21 CFR Part 117 (throughout)\r\n\n21 CFR Part 211 (throughout)\r\n\n21 CFR Part 212 (throughout)\r\n\n21 CFR Part 225 (throughout)\r\n\n21 CFR Part 226 (throughout)\r\n\n21 CFR Part 312 (throughout)\r\n\n21 CFR Part 606 (throughout)\r\n\n21 CFR Part 810 (throughout)\r\n\n21 CFR Part 812 (throughout)\r\n\n21 CFR Part 820 (throughout)\r\n\n29 CFR Part 1910.134 (c)\r\n\n29 CFR Part 1910.1030 (throughout)\r\n\n29 CFR Part 1910.1200 (e)\r\n\n29 CFR Part 1910.1450 (throughout)\r\n\n40 CFR Part 262.214\r\n\n42 CFR Part 73 (throughout)\r\n\n42 CFR Part 93.300\u20135\r\n\n42 CFR Part 493.1200\r\n\n42 CFR Part 493.1232\r\n\n42 CFR Part 493.1239\r\n\n42 CFR Part 493.1251\r\n\n42 CFR Part 493.1291 (j)\r\n\n42 CFR Part 493.1773 (c\u2013d)\r\n\n45 CFR Part 160.310\r\n\n45 CFR Part 164 (throughout)\r\n\n61 FR 38806 (throughout)\r\n\nA2LA C211 (throughout)\r\n\nA2LA C223 (throughout)\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\nAAVLD Requirements for an AVMDL (throughout)\r\n\nACMG Technical Standards for Clinical Genetics Laboratories (throughout)\r\n\nAIHA-LAP Policies 2022 Appendix H5.8\r\n\nASTM E1188-11 3.5.2\r\n\nASTM E1492-11 4.3.3.3 and 4.4.4\r\n\nASTM E1578-18 D-1-2\r\n\nBRC GSFS, Issue 8, 3.1.2\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nBRC GSFS, Issue 8, 5.6.2.2\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual (throughout)\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)\r\n\nCJIS Security Policy (throughout)\r\n\nCLSI QMS22 (throughout)\r\n\nEPA 815-R-05-004 (throughout)\r\n\nEPA ERLN Laboratory Requirements (throughout)\r\n\nEPA QA\/G-5 (throughout)\r\n\nE.U. Commission Directive 2003\/94\/EC (throughout)\r\n\nFDA Hazard Analysis Critical Control Point (throughout)\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\nIFS Food 7, Part 2 (throughout)\r\n\nIFS PACsecure 2, Part 2 (throughout)\r\n\nISO 15189:2012 (throughout)\r\n\nISO\/IEC 17025:2017 (throughout)\r\n\nISO\/TS 22002-1:2009 (throughout)\r\n\nISO\/TS 22002-4:2013 (throughout)\r\n\nISO\/TS 22002-6:2016 (throughout)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5 (throughout)\r\n\nOECD GLP Principles 8\r\n\nOSHA 1910.1020 (throughout)\r\n\nOSHA 1910.1200(b)(3)\r\n\nOSHA 1910.1450(h)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\nSQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nUSDA Data and Instrumentation for PDP (throughout)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines (throughout)\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3\r\n\nUSDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\nWADA International Standard for Laboratories (ISL) (throughout)\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\r\n\nWHO Technical Report Series, #961, Annex 13 (throughout)\r\n\nWHO Technical Report Series, #986, Annex 2 (throughout)\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.2 The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\n\n\n\n21 CFR Part 1.1154 (c)\r\n\n21 CFR Part 820.40 (a)\r\n\n42 CFR Part 493.1251 (e)\r\n\nA2LA C211 4.3\r\n\nAAVLD Requirements for an AVMDL Sec. 4.3\r\n\nASTM E1578-18 D-1-3\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nEPA 815-R-05-004 Chap. III, Sec. 11\r\n\nEPA ERLN Laboratory Requirements 4.2.4.2\r\n\nEPA QA\/G-5 2.1.9\r\n\nISO 15189:2012 4.3\r\n\nISO 15189:2012 5.5.3\r\n\nISO 15189:2012 5.9.3\r\n\nISO\/IEC 17025:2017 7.5.2\r\n\nISO\/IEC 17025:2017 8.3.2\r\n\nUSDA Administrative Procedures for the PDP 5.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.5\n\n\n7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.\n\n\nASTM E1578-18 D-1-4\n\n7.4 The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1151\r\n\n21 CFR Part 1.1152 (e)\r\n\n21 CFR Part 106.91 (c)\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.315\r\n\n21 CFR Part 111.320\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.160\r\n\n21 CFR Part 212.20 (c)\r\n\n21 CFR Part 212.60 (c)\r\n\n21 CFR Part 226.58 (e)\r\n\n21 CFR Part 820.250 (b)\r\n\n42 CFR Part 493.43 (c)\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nASTM E1578-18 D-1-5\r\n\nBRC GSFS, Issue 8, 5.6.1.1\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.3\r\n\nCodex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\nCodex Alimentarius CXS 234-1999 (throughout)\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 5\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\nIFS Food 7, Part 2, 5.5.2\r\n\nIFS Food 7, Part 2, 5.6.2\r\n\nIFS PACsecure 2, Part 2, 5.5.2\r\n\nIFS PACsecure 2, Part 2, 5.6.2\r\n\nISO\/IEC 17025:2017 6.5\r\n\nISO\/IEC 17025:2017 7.2.1.3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)\r\n\nUSDA Administrative Procedures for the PDP 8.4\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1\r\n\nWHO Technical Report Series, #986, Annex 2, 15.14\n\n\n7.5 The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1151\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.320\r\n\n21 CFR Part 212.20 (c)\r\n\n21 CFR Part 212.70 (b)\r\n\nA2LA C211 5.4.5\r\n\nA2LA C223 5.4\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.4\r\n\nABFT Accreditation Manual Sec. G-12, -14, and -15\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C10\r\n\nACMG Technical Standards for Clinical Genetics Laboratories F7.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4\r\n\nCodex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\nCodex Alimentarius CXS 234-1999 (throughout)\r\n\nEPA QA\/G-5 2.2.4\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\nISO\/IEC 17025:2017 7.2.2.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\nUSDA Administrative Procedures for the PDP 8.4\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6\r\n\nWHO Technical Report Series, #961, Annex 13, 10.1\r\n\nWHO Technical Report Series, #986, Annex 2, 4.11\r\n\nWHO Technical Report Series, #986, Annex 2, 15.13\n\n\n7.6 The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\n\n\n\n7 CFR Part 331.10\r\n\n7 CFR Part 331.15\r\n\n9 CFR Part 2.32\r\n\n9 CFR Part 121.10 \r\n\n9 CFR Part 121.15 \r\n\n10 CFR Part 30.34 (j-3)\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 11.10 (i)\r\n\n21 CFR Part 58.29\r\n\n21 CFR Part 211.25\r\n\n21 CFR Part 225.10\r\n\n21 CFR Part 226.10\r\n\n21 CFR Part 226.40\r\n\n21 CFR Part 820.25\r\n\n29 CFR Part 1910.134 (c)\r\n\n29 CFR Part 1910.1030 (g-2)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n29 CFR Part 1910.1200 (h)\r\n\n29 CFR Part 1910.1450 (f)\r\n\n40 CFR Part 262.207\r\n\n40 CFR Part 262.210\u201312\r\n\n42 CFR Part 73.10\r\n\n42 CFR Part 73.15\r\n\n42 CFR Part 493.43 (c)\r\n\n42 CFR Part 493.1235\r\n\n42 CFR Part 493.1251\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 417.5\r\n\nA2LA C211 5.2\r\n\nA2LA C223 5.2\r\n\nA2LA C223 5.7\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\nAAVLD Requirements for an AVMDL Appendix 1\r\n\nABFT Accreditation Manual Sec. B\r\n\nACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.4\r\n\nAIHA-LAP Policies 2022 (throughout)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASTM E1578-18 C-3-5\r\n\nASTM E1578-18 D-1-6\r\n\nASTM E1578-18 E-1-6\r\n\nBRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nCAP Laboratory Accreditation Manual\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCLSI QMS22 (throughout)\r\n\nE.U. Annex 11-2\r\n\nE.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\nEPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 1\r\n\nEPA QA\/G-5 2.1.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.1\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.1\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nISO 15189:2012 4.1.2.1\r\n\nISO 15189:2012 5.1.6\r\n\nISO 15189:2012 5.1.9\r\n\nISO\/IEC 17025:2017 6.2.2\r\n\nISO\/IEC 17025:2017 6.2.3\r\n\nISO\/IEC 17025:2017 6.2.5\r\n\nISO\/IEC 17025:2017 6.2.6\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nOECD GLP Principles 1.1.2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\n\n\n7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n\n\nASTM E1578-18 D-1-7\n\n7.8 The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\n\n\nAAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5\r\nEPA ERLN Laboratory Requirements 4.10.6\n\n7.9 The system shall support the addition of accurate cross-references and page numbers to new documents.\n\n\nAAVLD Requirements for an AVMDL Sec. 4.3.4\n\n7.10 The system shall be capable of uniquely identifying documents created in and added to the system.\n\n\nAPHL 2019 LIS Project Management Guidebook\r\n\n\n7.11 The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\n\n\n\n8. Resource management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n9 CFR Part 2.32\r\n\n10 CFR Part 20.2103\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 110.10 (c)\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.10\r\n\n29 CFR Part 1910.120\r\n\n29 CFR Part 1910.134 (m)\r\n\n29 CFR Part 1910.1030 (h-1)\r\n\n29 CFR Part 1910.1450 (j)\r\n\n40 CFR Part 262.207\r\n\nA2LA C211 4.13.2.3\r\n\nA2LA C223 5.2\r\n\nA2LA C223 5.7\r\n\nACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nBRC GSFS, Issue 8, 7.3.1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.2.3\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nEPA QA\/G-5 2.1.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.1\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.1\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nNIST 800-53, Rev. 5, AT-3 and -4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOSHA 1910.1020 (throughout)\r\n\nOSHA 1910.1200(b)(3) and (h)\r\n\nOSHA 1910.1450 (throughout)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nUSDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\r\n\nWHO Technical Report Series, #996, Annex 5, 8.1\n\n\n8.1 The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\n\n\n\n21 CFR Part 820.198\r\n\n42 CFR Part 493.1233\r\n\nBRC GSFS, Issue 8, 3.10.1\u20132\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21\r\n\nIFS Food 7, Part 2, 5.8\r\n\nIFS PACsecure 2, Part 2, 5.8\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)\r\n\nWADA International Standard for Laboratories (ISL) 5.3.10\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\n\n\n8.2 The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.\n\n\n\n5 CFR Part 930.301\r\n\n7 CFR Part 331.15\r\n\n9 CFR Part 121.15\r\n\n21 CFR Part 120.12\r\n\nhttps:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123 21 CFR Part 123.10]\r\n\n21 CFR Part 211.25\r\n\n29 CFR Part 1910.1450 (f)\r\n\n42 CFR Part 73.15\r\n\nA2LA C223 5.2\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3\r\n\nASTM E1578-18 E-1-1\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nCJIS Security Policy 5.2.1\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nNIST 800-53, Rev. 5, AT-2 and AT-3\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Sampling Procedures for PDP 6.1.2\u20133\r\n\nWHO Technical Report Series, #986, Annex 2, 10\n\n\n8.3 The system shall allow training sessions and reviews to be scheduled for personnel.\n\n\n\n5 CFR Part 930.301\r\n\n29 CFR Part 1910.1450 (f)\r\n\nABFT Accreditation Manual Sec. B\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7\r\n\nASTM E1578-18 E-1-2\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.4 The system should provide access to relevant training materials to personnel attending training sessions.\n\n\n\n5 CFR Part 930.301\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 110.10 (c)\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.10\r\n\n29 CFR Part 1910.1450 (f)\r\n\n40 CFR Part 262.207\r\n\nA2LA C223 5.2\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5\r\n\nASTM E1578-18 E-1-3\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.2.3\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nEPA QA\/G-5 2.1.8\r\n\nE.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nISO 15189:2012 5.1.9\r\n\nNIST 800-53, Rev. 5, AT-2\u2013AT-4\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e\r\n\nUSDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (e)\r\n\nWHO Technical Report Series, #986, Annex 2, 9.4\r\n\nWHO Technical Report Series, #986, Annex 2, 10\n\n\n8.5 The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\n\n\n\nABFT Accreditation Manual Sec. B\r\n\nASTM E1578-18 E-1-4\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\n\n\n8.6 The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\n\n\n\nASTM E1578-18 E-1-5\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nNIST 800-53, Rev. 5, AT-2 and AT-3\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.7 The system should be able to produce a training matrix of personnel.\n\n\n\n7 CFR Part 331.15\r\n\n9 CFR Part 121.10 \r\n\n9 CFR Part 121.15 \r\n\n21 CFR Part 11.10 (i)\r\n\n21 CFR Part 58.29\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 211.25\r\n\n21 CFR Part 225.10\r\n\n21 CFR Part 226.10\r\n\n21 CFR Part 226.40\r\n\n21 CFR Part 820.25\r\n\n29 CFR Part 1910.1030 (g-2)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n29 CFR Part 1910.1200 (h)\r\n\n29 CFR Part 1910.1450 (e)\r\n\n42 CFR Part 73.10\r\n\n42 CFR Part 73.15\r\n\n42 CFR Part 493.43 (c)\r\n\n42 CFR Part 493.1235\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nA2LA C223 5.2\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\nAAVLD Requirements for an AVMDL Appendix 1\r\n\nABFT Accreditation Manual Sec. B\r\n\nAIHA-LAP Policies 2022 (various parts)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASTM E1578-18 C-3-5\r\n\nASTM E1578-18 D-1-6\r\n\nASTM E1578-18 E-1-6\r\n\nBRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nE.U. Annex 11-2\r\n\nEPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 1\r\n\nEPA QA\/G-5 2.1.8\r\n\nISO 15189:2012 4.1.2.1\r\n\nISO 15189:2012 5.1.6\r\n\nISO 15189:2012 5.1.9\r\n\nISO\/IEC 17025:2017 6.2.2\r\n\nISO\/IEC 17025:2017 6.2.3\r\n\nISO\/IEC 17025:2017 6.2.5\r\n\nISO\/IEC 17025:2017 6.2.6\r\n\nOECD GLP Principles 1.1.2\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\n\n\n8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n\n\n\n9. Compliance management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17 \r\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1251 (d)\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nASTM E1578-18 C-4-7\r\n\nASTM E1578-18 E-2-1\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Annex 11-9\r\n\nE.U. Annex 11-14\r\n\nOECD GLP Principles 8.3.5\r\n\nUSDA Data and Instrumentation for PDP 8.1.3\n\n\n9.1 The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-2\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCJIS Security Policy Appendix G.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Annex 11-9\r\n\nE.U. Annex 11-12.4\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nNIST 800-53, Rev. 5, AC-2(4) and AC-6(9)\r\n\nNIST 800-53, Rev. 5, AU-2 and AU-3\r\n\nNIST 800-53, Rev. 5, CM-5(1)\r\n\nOECD GLP Principles 8.3.5\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n9.2 The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1274\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-3\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCLSI QMS22 2.2.3.2\r\n\nCLSI QMS22 2.4.3\r\n\nE.U. Annex 11-12.4\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nNIST 800-53, Rev. 5, AU-3 and AU-8\r\n\nOECD GLP Principles 8.3.5\r\n\nUSDA Data and Instrumentation for PDP 8.1.4\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.3 The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-4\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nICH GCP 4.9.0 and 4.9.3\r\n\nNIST 800-53, Rev. 5, AU-3\r\n\nOECD GLP Principles 8.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.4 The system's audit trail shall document the previous and current value of a modified field.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1251 (d)\r\n\n45 CFR Part 164.310\r\n\nASTM E1578-18 E-2-5\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nE.U. Annex 11-14\r\n\nOECD GLP Principles 8.3.5\n\n\n9.5 The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\n\n\n21 CFR Part 11.70\r\nE.U. Annex 11-14\n\n9.6 The system shall prevent a user from copying and pasting the electronic signature of another user.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 58.130 (e)\r\n\n42 CFR Part 493.1274 (d)\r\n\nE.U. Annex 11-9\r\n\nNIST 800-53, Rev. 5, AU-6 and AU-12\r\n\nOECD GLP Principles 8.3.5\n\n\n9.7 The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\n\n\n\n10. Instrument and equipment management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-3-1\n\n10.1 The system should provide a means for tracking usage of laboratory equipment and instruments.\n\n\nASTM E1578-18 E-3-2\n\n10.2 The system shall provide a means for planning the use of and reserving equipment and instruments.\n\n\nASTM E1578-18 E-3-3\n\n10.3 The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\n\n\nASTM E1578-18 E-3-4\n\n10.4 The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\n\n\nASTM E1578-18 E-3-5\n\n10.5 The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\n\n\nASTM E1578-18 E-3-6\n\n10.6 The system shall be able to group instruments together in specific ways, including by type and laboratory location.\n\n\n\n21 CFR Part 110.40 (f)\r\n\n21 CFR Part 211.67\u201368\r\n\n21 CFR Part 211.160 (b-4)\r\n\n21 CFR Part 212.30 (b)\r\n\n21 CFR Part 212.60 (e)\r\n\n21 CFR Part 225.30 (b-4)\r\n\n21 CFR Part 606.60\r\n\n21 CFR Part 820.70 (g)\r\n\n21 CFR Part 820.72\r\n\n42 CFR Part 493.1252 (b-3)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.5.2\r\n\nA2LA C223 5.5\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5\r\n\nABFT Accreditation Manual Sec. E-20\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1\r\n\nAIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\nASTM E1578-18 E-3-7\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.6.1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nISO 15189:2012 5.3.1.4\r\n\nISO\/IEC 17025:2017 6.4.7\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nISO\/TS 22002-4:2013, 4.7.1\r\n\nISO\/TS 22002-6:2016, 4.7\r\n\nNIST 800-53, Rev. 5, MA-2 and MA-2(2)\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Data and Instrumentation for PDP 5.2\r\n\nUSDA Data and Instrumentation for PDP 6\r\n\nWADA International Standard for Laboratories (ISL) 5.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 13.5\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\n\n\n\n21 CFR Part 225.30 (b-4)\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5.9\r\n\nASTM E1578-18 E-3-8\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.8 The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\n\n\n\n21 CFR Part 211.160 (b-4)\r\n\nA2LA C211 5.5.7\r\n\nA2LA C223 5.6\r\n\nABFT Accreditation Manual Sec. E-21\r\n\nASTM E1578-18 E-3-9\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nCLSI QMS22 2.1.2.1\r\n\nIFS Food 7, Part 2, 5.4.3\r\n\nIFS PACsecure 2, Part 2, 5.4.3\r\n\nISO 15189:2012 5.3.1.5\r\n\nISO\/IEC 17025:2017 6.4.9\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)\r\n\nWHO Technical Report Series, #986, Annex 2, 13.10\n\n\n10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.\n\n\n\n21 CFR Part 111.117\r\n\n21 CFR Part 820.72 (b-2)\r\n\nASTM E1578-18 E-3-10\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nNIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\n\n\n\n21 CFR Part 820.72 (b-1)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.6.2.1\r\n\nA2LA C223 5.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.6.1\u20132\r\n\nAIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nISO\/IEC 17025:2017 6.5\r\n\nISO\/TS 22002-4:2013, 4.7.1\r\n\nISO\/TS 22002-6:2016, 4.7\r\n\nOECD GLP Principles 4.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.2\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)\r\n\nUSDA Data and Instrumentation for PDP 6.1\n\n\n10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\n\n\nASTM E1578-18 E-3-11\n\n10.12 The system shall support the use of predefined intervals when calculating instrument event dates.\n\n\n\n21 CFR Part 110.40 (f)\r\n\n21 CFR Part 211.105 (b)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.5.4 and 5.5.5\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5.4\u20135\r\n\nASTM E1578-18 E-3-12\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1\r\n\nIFS Food 7, Part 2, 5.4.1\r\n\nIFS PACsecure 2, Part 2, 5.4.1\r\n\nISO 15189:2012 5.3.1.7\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nISO\/IEC 17025:2017 6.4.13\r\n\nNIST 800-53, Rev. 5, CM-8\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\nUSDA Administrative Procedures for the PDP 7.2\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4\r\n\nWHO Technical Report Series, #961, Annex 13, 6.1\n\n\n10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\n\n\nASTM E1578-18 E-3-13\n\n10.14 The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\n\n\n\n10 CFR Part 20.2103\r\n\n21 CFR Part 58.63\r\n\n21 CFR Part 111.117\r\n\n21 CFR Part 211.67\u201368\r\n\n21 CFR Part 211.160 (b-4)\r\n\n21 CFR Part 211.182\r\n\n21 CFR Part 211.194 (d)\r\n\n21 CFR Part 212.30 (b)\r\n\n21 CFR Part 212.60 (e)\r\n\n21 CFR Part 820.70 (g)\r\n\n21 CFR Part 820.72\r\n\n42 CFR Part 493.1254\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 4.13.2.1\r\n\nA2LA C211 5.5.2\r\n\nA2LA C211 5.10.4\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5\r\n\nABFT Accreditation Manual Sec. E-20 and -23\r\n\nABFT Accreditation Manual Sec. F-1 and I-1\r\n\nAIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\nASTM E1578-18 E-3-14\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.2.1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nISO 15189:2012 5.3.1.4\r\n\nISO\/IEC 17025:2017 6.4.4\r\n\nNIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 4.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Data and Instrumentation for PDP 5.4\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c\r\n\nWADA International Standard for Laboratories (ISL) 5.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 15.46\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.15 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\n\n\n\n11. Batch and lot management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 58.105 (a)\r\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nASTM E1578-18 E-4-1\r\n\nEPA ERLN Laboratory Requirements 3.3\r\n\nEPA ERLN Laboratory Requirements 4.10.1\r\n\nOECD GLP Principles 6.2\n\n\n11.1 The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\n\n\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nASTM E1578-18 E-4-2\r\n\nEPA ERLN Laboratory Requirements 4.10.1\n\n\n11.2 The system shall maintain the links between component parts of a batch and track the batch throughout the system.\n\n\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 820.65\r\n\nASTM E1578-18 E-4-3\n\n\n11.3 The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\n\n\nASTM E1578-18 E-4-4\n\n11.4 The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\n\n\nE.U. Annex 11-15\n\n11.5 The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\n\n\n\n12. Scheduled event management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 129.80 (g)\r\nASTM E1578-18 E-5-1\r\nUSDA Sampling Procedures for PDP 5.6\u20137\n\n12.1 The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.\n\n\n21 CFR Part 212.61 (a)\r\n21 CFR Part 211.166 (b)\r\nASTM E1578-18 E-5-2\n\n12.2 The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.\n\n\nASTM E1578-18 E-5-3\n\n12.3 The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\n\n\nASTM E1578-18 E-5-4\n\n12.4 The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).\n\n\nASTM E1578-18 E-5-5\n\n12.5 The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\n\n\n\n13. Instrument data capture and control \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-6-1\n\n13.1 The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\n\n\nASTM E1578-18 E-6-2\n\n13.2 The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\n\n\nASTM E1578-18 E-6-3\n\n13.3 The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\n\n\nASTM E1578-18 E-6-4\n\n13.4 The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\n\n\nASTM E1578-18 E-6-5\n\n13.5 The system should be able to accept the results uploaded from an interfaced instrument.\n\n\nASTM E1578-18 E-6-6\n\n13.6 The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\n\n\nASTM E1578-18 E-6-7\n\n13.7 The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\n\n\nASTM E1578-18 E-6-8\n\n13.8 The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\n\n\n\n14. Standard and reagent management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 58.83\r\n\n29 CFR Part 1910.1200 (g)\r\n\n29 CFR Part 1910.1450 (h)\r\n\n42 CFR Part 493.1252 (c)\r\n\nABFT Accreditation Manual Sec. E-17\r\n\nASTM E1578-18 E-7-1\r\n\nISO 15189:2012 5.3.2.4\u20135\r\n\nOECD GLP Principles 4.4\n\n\n14.1 The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\n\n\n\n7 CFR Part 331.3\r\n\n9 CFR Part 121.3\r\n\n21 CFR Part 312.58 (b)\r\n\n42 CFR Part 73.3\u20134 (c)\r\n\nASTM E1578-18 E-7-2\r\n\nEPA ERLN Laboratory Requirements 4.1.12\r\n\nISO 15189:2012 5.3.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 12.20\n\n\n14.2 The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\n\n\nASTM E1578-18 E-7-3\r\nISO 15189:2012 5.3.2.4\n\n14.3 The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\n\n\nASTM E1578-18 E-7-4\r\nISO 15189:2012 5.3.2.4\n\n14.4 The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\n\n\nASTM E1578-18 E-7-5\r\nISO 15189:2012 5.3.2.4\n\n14.5 The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\n\n\n\n15. Inventory management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-8-1\r\nCAP Laboratory Accreditation Manual\r\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples and specimens.\n\n\n\n21 CFR Part 212.60 (d)\r\n\nASTM E1578-18 E-8-2\r\n\nCLSI QMS22 2.1.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.2 The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\n\n\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.101\r\n\n21 CFR Part 212.60 (d)\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 606.120 (b)\r\n\n29 CFR Part 1910.1030 (g)\r\n\n29 CFR Part 1910.1096 (e-6)\r\n\n29 CFR Part 1910.1200 (f-6) and (f-10)\r\n\n40 CFR Part 262.206\r\n\nASTM E1578-18 E-8-3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOSHA 1910.1200(b)(3) and (f)\r\n\nOSHA 1910.1450(h)\r\n\nWHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41\r\n\nWHO Technical Report Series, #986, Annex 2, 15.10\u201312\n\n\n15.3 The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\n\n\n\n21 CFR Part 117.420\r\n\n21 CFR Part 212.40 (c)\r\n\n21 CFR Part 820.50\r\n\nA2LA C211 4.6\r\n\nASTM E1578-18 E-8-4\r\n\nBRC GSFS, Issue 8, 3.5.1.4\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5\r\n\nIFS Food 7, Part 2, 4.4.1\r\n\nIFS PACsecure 2, Part 2, 4.4.1\r\n\nISO\/TS 22002-1:2009, 9.2\r\n\nISO\/TS 22002-4:2013, 4.6.2\r\n\nISO\/TS 22002-6:2016, 4.6.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.4.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)\r\n\nUSDA Administrative Procedures for the PDP 7.1\r\n\nWHO Technical Report Series, #961, Annex 13, 7.1 and 7.3\r\n\nWHO Technical Report Series, #986, Annex 2, 14.8\n\n\n15.4 The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\n\n\n\n21 CFR Part 211.196\r\n\n21 CFR Part 212.90\r\n\n21 CFR Part 225.110\r\n\n21 CFR Part 606.165\r\n\n29 CFR Part 1910.1450 Appendix A (I)\r\n\nA2LA C211 4.6\r\n\nASTM E1578-18 E-8-5\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5\n\n\n15.5 The system should provide a means for accurately recording the receipt, approval, distribution, and disposal of materials.\n\n\n\n21 CFR Part 211.82 (b)\r\n\n21 CFR Part 211.84 (a)\r\n\n21 CFR Part 211.89\r\n\n21 CFR Part 211.110 (d)\r\n\n21 CFR Part 211.142 (a)\r\n\n21 CFR Part 212.40 (c)\r\n\nASTM E1578-18 E-8-6\r\n\nWHO Technical Report Series, #986, Annex 2, 12.18\n\n\n15.6 The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\n\n\n\n21 CFR Part 211.89\r\n\n21 CFR Part 211.110 (d)\r\n\n42 CFR Part 493.1252 (d)\r\n\nASTM E1578-18 E-8-7\n\n\n15.7 The system should allow authorized personnel to retire faulty or poor quality materials from use.\n\n\n\n21 CFR Part 211.89\r\nASTM E1578-18 E-8-8\n\n\n15.8 The system shall clearly designate a standard or reagent as being disposed or consumed.\n\n\n\n16. Investigation and quality management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 312.62 (b)\r\n21 CFR Part 812.140 (a-3)\n\n16.1 The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\n\n\n\n21 CFR Part 312.57 (a)\r\n\n21 CFR Part 312.62 (a)\r\n\n21 CFR Part 606.165\r\n\n21 CFR Part 812.140 (a-2) and (b-2)\n\n\n16.2 The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\n\n\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 58.81 (a)\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.111\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 211.194\r\n\n21 CFR Part 606.171\r\n\n42 CFR Part 493.1253 (b-2)\r\n\nA2LA C211 5.4\r\n\nABFT Accreditation Manual C-16\r\n\nABFT Accreditation Manual F-2\r\n\nABFT Accreditation Manual J-3\r\n\nASTM E1578-18 E-9-1\r\n\nBRC GSFS, Issue 8, 5.6.2.3\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nCLSI QMS22 2.2.2.2\r\n\nEPA ERLN Laboratory Requirements 3.3\r\n\nEPA QA\/G-5 2.2.4\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\nISO\/IEC 17025:2017 7.2.1.7\r\n\nISO\/IEC 17025:2017 7.2.2.1\r\n\nISO\/IEC 17025:2017 7.10.2\r\n\nISO\/IEC 17025:2017 8.7.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 7.3\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)\r\n\nUSDA Administrative Procedures for the PDP 8.2.2\r\n\nWADA International Standard for Laboratories (ISL) 5.3.6\r\n\nWHO Technical Report Series, #986, Annex 2, 16.3\n\n\n16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\n\n\n42 CFR Part 493.1282\r\nASTM E1578-18 E-9-2\r\nE.U. Commission Reg. No. 2073\/2005 Article 9\n\n16.4 The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\n\n\n\n21 CFR Part 606.100 (c)\r\n\n42 CFR Part 493.1282\r\n\nASTM E1578-18 E-9-3\r\n\nCLSI QMS22 2.1.2.1\r\n\nCLSI QMS22 2.2.2.3\r\n\nEPA QA\/G-5 2.2.10\r\n\nWHO Technical Report Series, #986, Annex 2, 17.12\r\n\nWHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.5 The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\n\n\n\n10 CFR Part 30.34 (g)\r\n\n21 CFR Part 112.147\r\n\n21 CFR Part 225.58 (d)\r\n\n21 CFR Part 225.158\r\n\n21 CFR Part 606.100 (c)\r\n\n21 CFR Part 820.100\r\n\n42 CFR Part 493.1282\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nA2LA C211 4.9 and 4.11\r\n\nASTM E1578-18 E-9-4\r\n\nBRC GSFS, Issue 8, 3.4.3\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCLSI QMS22 2.6.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nFDA Hazard Analysis Critical Control Point Principle 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5, IR-5\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\nWADA International Standard for Laboratories (ISL) 5.3.9\r\n\nWHO Technical Report Series, #961, Annex 13, 11.1\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\r\n\nWHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\n\n\n\n21 CFR Part 225.58 (d)\r\n\n21 CFR Part 225.158\r\n\n42 CFR Part 493.1282\r\n\n42 CFR Part 493.1289\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nA2LA C211 4.8 and 4.11\r\n\nASTM E1578-18 E-9-5\r\n\nBRC GSFS, Issue 8, 3.4.3\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.3.4\r\n\nCJIS Security Policy Appendix G.7\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nFDA Hazard Analysis Critical Control Point Principle 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5, AU-6(1)\r\n\nNIST 800-53, Rev. 5, IR-4(1) and IR-5\r\n\nNIST 800-53, Rev. 5, SI-2 and SI-4\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\n\n\n16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\n\n\nASTM E1578-18 E-9-6\n\n16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\n\n\n9 CFR Part 2.35\n\n16.9 The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#12._Scheduled_event_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#12._Scheduled_event_management<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 2 May 2022, at 22:08.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2,552 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","e65f4869b4cef313b97d330551ce3dde_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Maintaining_Laboratory_Workflow_and_Operations rootpage-LII_LIMSpec_Maintaining_Laboratory_Workflow_and_Operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Maintaining Laboratory Workflow and Operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"7._Document_and_records_management\">7. Document and records management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/part-20\" target=\"_blank\">10 CFR Part 20 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.213\u201314<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(e) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.1<\/b> The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.214<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.300\" target=\"_blank\">42 CFR Part 93.300\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1773\" target=\"_blank\">42 CFR Part 493.1773 (c\u2013d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/160.310\" target=\"_blank\">45 CFR Part 160.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 Appendix H5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.2<\/b> The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.3<\/b> The system shall be able to clearly provide the most current version of a document and archive prior versions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.4<\/b> The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.91 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.14<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.5<\/b> The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-12, -14, and -15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.13<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.6<\/b> The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.10\" target=\"_blank\">7 CFR Part 331.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (j-3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.210\" target=\"_blank\">40 CFR Part 262.210\u201312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.7<\/b> The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.8<\/b> The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.9<\/b> The system shall support the addition of accurate cross-references and page numbers to new documents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.10<\/b> The system shall be capable of uniquely identifying documents created in and added to the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>7.11<\/b> The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"8._Resource_management\">8. Resource management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (m)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-3 and -4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.1<\/b> The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.198\" target=\"_blank\">21 CFR Part 820.198<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1233\" target=\"_blank\">42 CFR Part 493.1233<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.10.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.2<\/b> The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123<\/a> 21 CFR Part 123.10]<br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.3<\/b> The system shall allow training sessions and reviews to be scheduled for personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.4<\/b> The system should provide access to relevant training materials to personnel attending training sessions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2\u2013AT-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.5<\/b> The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.6<\/b> The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.7<\/b> The system should be able to produce a training matrix of personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (various parts)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.8<\/b> The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"9._Compliance_management\">9. Compliance management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.1<\/b> The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-2 and AU-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.2<\/b> The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3 and AU-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.3<\/b> The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.4<\/b> The system's audit trail shall document the previous and current value of a modified field.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.5<\/b> The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>9.6<\/b> The system shall prevent a user from copying and pasting the electronic signature of another user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6 and AU-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.7<\/b> The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"10._Instrument_and_equipment_management\">10. Instrument and equipment management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.1<\/b> The system should provide a means for tracking usage of laboratory equipment and instruments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.2<\/b> The system shall provide a means for planning the use of and reserving equipment and instruments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.3<\/b> The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.4<\/b> The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.5<\/b> The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.6<\/b> The system shall be able to group instruments together in specific ways, including by type and laboratory location.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.60\" target=\"_blank\">21 CFR Part 606.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (b-3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2 and MA-2(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.7<\/b> The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.8<\/b> The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.9<\/b> The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.10<\/b> The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.6.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.11<\/b> The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.12<\/b> The system shall support the use of predefined intervals when calculating instrument event dates.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.4 and 5.5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.13<\/b> The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-13<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.14<\/b> The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.63\" target=\"_blank\">21 CFR Part 58.63<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.182\" target=\"_blank\">21 CFR Part 211.182<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1254\" target=\"_blank\">42 CFR Part 493.1254<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20 and -23<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. F-1 and I-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.46<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.15<\/b> The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"11._Batch_and_lot_management\">11. Batch and lot management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.1<\/b> The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.2<\/b> The system shall maintain the links between component parts of a batch and track the batch throughout the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.65\" target=\"_blank\">21 CFR Part 820.65<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.3<\/b> The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>11.4<\/b> The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-15<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>11.5<\/b> The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"12._Scheduled_event_management\">12. Scheduled event management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.6\u20137<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.1<\/b> The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.2<\/b> The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.3<\/b> The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.4<\/b> The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.5<\/b> The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"13._Instrument_data_capture_and_control\">13. Instrument data capture and control<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.1<\/b> The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.2<\/b> The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.3<\/b> The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.4<\/b> The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.5<\/b> The system should be able to accept the results uploaded from an interfaced instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.6<\/b> The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.7<\/b> The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.8<\/b> The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"14._Standard_and_reagent_management\">14. Standard and reagent management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.83\" target=\"_blank\">21 CFR Part 58.83<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>14.1<\/b> The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.3\" target=\"_blank\">7 CFR Part 331.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.3\" target=\"_blank\">9 CFR Part 121.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.3\" target=\"_blank\">42 CFR Part 73.3\u20134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.20<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>14.2<\/b> The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.3<\/b> The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.4<\/b> The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.5<\/b> The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"15._Inventory_management\">15. Inventory management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>15.1<\/b> The system should be capable of accurately tracking the specific quantities of received and consumed test samples and specimens.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.2<\/b> The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (f-6) and (f-10)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.206\" target=\"_blank\">40 CFR Part 262.206<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.10\u201312<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.3<\/b> The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.50\" target=\"_blank\">21 CFR Part 820.50<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.4<\/b> The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.196\" target=\"_blank\">21 CFR Part 211.196<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.90\" target=\"_blank\">21 CFR Part 212.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 Appendix A (I)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.5<\/b> The system should provide a means for accurately recording the receipt, approval, distribution, and disposal of materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.82\" target=\"_blank\">21 CFR Part 211.82 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.142\" target=\"_blank\">21 CFR Part 211.142 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.6<\/b> The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.7<\/b> The system should allow authorized personnel to retire faulty or poor quality materials from use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.8<\/b> The system shall clearly designate a standard or reagent as being disposed or consumed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"16._Investigation_and_quality_management\">16. Investigation and quality management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.1<\/b> The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-2) and (b-2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.2<\/b> The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.81\" target=\"_blank\">21 CFR Part 58.81 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.171\" target=\"_blank\">21 CFR Part 606.171<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1253\" target=\"_blank\">42 CFR Part 493.1253 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual F-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual J-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.3<\/b> The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.4<\/b> The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.5<\/b> The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.147<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.100\" target=\"_blank\">21 CFR Part 820.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.9 and 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 11.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.6<\/b> The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1289\" target=\"_blank\">42 CFR Part 493.1289<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.8 and 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-4(1) and IR-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2 and SI-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.7<\/b> The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.8<\/b> The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.9<\/b> The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173541\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.104 seconds\nReal time usage: 0.111 seconds\nPreprocessor visited node count: 1035\/1000000\nPost\u2010expand include size: 141529\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 20.237 1 -total\n 11.99% 2.426 1 Template:LIMSpec\/Document_management\n 10.55% 2.135 1 Template:LIMSpec\/Resource_management\n 9.87% 1.998 1 Template:LIMSpec\/Instrument_and_equipment_management\n 9.68% 1.958 1 Template:LIMSpec\/Compliance_management\n 9.13% 1.848 1 Template:LIMSpec\/Batch_and_lot_management\n 9.07% 1.836 1 Template:LIMSpec\/Investigation_and_quality_management\n 8.97% 1.815 1 Template:LIMSpec\/Inventory_management\n 8.81% 1.782 1 Template:LIMSpec\/Scheduled_event_management\n 8.72% 1.764 1 Template:LIMSpec\/Instrument_data_capture_and_control\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11181-0!canonical and timestamp 20221202173541 and revision id 47569. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#12._Scheduled_event_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#12._Scheduled_event_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","e65f4869b4cef313b97d330551ce3dde_images":[],"e65f4869b4cef313b97d330551ce3dde_timestamp":1670002542,"294df292ed93e358a9df3501bb3de637_type":"article","294df292ed93e358a9df3501bb3de637_title":"11. Batch and lot management","294df292ed93e358a9df3501bb3de637_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#11._Batch_and_lot_management","294df292ed93e358a9df3501bb3de637_plaintext":"\n\nLII:LIMSpec\/Maintaining Laboratory Workflow and OperationsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.\n\n7. Document and records management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n7 CFR Part 331 (throughout)\r\n\n9 CFR Part 121 (throughout)\r\n\n10 CFR Part 20 (throughout)\r\n\n21 CFR Part 7 (throughout)\r\n\n21 CFR Part 117 (throughout)\r\n\n21 CFR Part 58 (throughout)\r\n\n21 CFR Part 211 (throughout)\r\n\n21 CFR Part 212 (throughout)\r\n\n21 CFR Part 225 (throughout)\r\n\n21 CFR Part 226 (throughout)\r\n\n21 CFR Part 312 (throughout)\r\n\n21 CFR Part 606 (throughout)\r\n\n21 CFR Part 810 (throughout)\r\n\n21 CFR Part 812 (throughout)\r\n\n21 CFR Part 820 (throughout)\r\n\n29 CFR Part 1910.134 (throughout)\r\n\n29 CFR Part 1910.1030 (throughout)\r\n\n29 CFR Part 1910.1200 (throughout)\r\n\n29 CFR Part 1910.1450 (throughout)\r\n\n40 CFR Part 262.213\u201314\r\n\n42 CFR Part 73 (throughout)\r\n\n42 CFR Part 493.1200\r\n\n42 CFR Part 493.1232\r\n\n42 CFR Part 493.1239\r\n\n42 CFR Part 493.1251\r\n\n42 CFR Part 493.1291 (j)\r\n\n45 CFR Part 164 (throughout)\r\n\n61 FR 38806 (throughout)\r\n\nA2LA C211 4.3\r\n\nA2LA C223 4.13\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\nAAVLD Requirements for an AVMDL (throughout)\r\n\nABFT Accreditation Manual (throughout)\r\n\nASTM E1188-11 3.5.2\r\n\nASTM E1492-11 4.3.3.3 and 4.4.4\r\n\nASTM E1578-18 D-1-1\r\n\nBRC GSFS, Issue 8, 3.1.1\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nBRC GSFS, Issue 8, 5.6.1.1\r\n\nBRC GSFS, Issue 8, 5.6.2.2\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual (throughout)\r\n\nCJIS Security Policy (throughout)\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)\r\n\nEPA 815-R-05-004 (throughout)\r\n\nEPA ERLN Laboratory Requirements (throughout)\r\n\nEPA QA\/G-5 (throughout)\r\n\nE.U. Commission Directive 2003\/94\/EC (throughout)\r\n\nFDA Hazard Analysis Critical Control Point (throughout)\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\nIFS Food 7, Part 2 (throughout)\r\n\nIFS PACsecure 2, Part 2 (throughout)\r\n\nISO 15189:2012 4.3\r\n\nISO 15189:2012 5.5.3\r\n\nISO 15189:2012 5.9.3\r\n\nISO\/IEC 17025:2017 5.3\r\n\nISO\/IEC 17025:2017 5.5\r\n\nISO\/IEC 17025:2017 8.3.2\r\n\nISO\/TS 22002-1:2009 (throughout)\r\n\nISO\/TS 22002-4:2013 (throughout)\r\n\nISO\/TS 22002-6:2016 (throughout)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5 (throughout)\r\n\nOECD GLP Principles 8\r\n\nOSHA 1910.1200(b)(3)\r\n\nOSHA 1910.1450(e) and (h)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\nSQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nUSDA Data and Instrumentation for PDP (throughout)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\nWHO Technical Report Series, #961, Annex 13 (throughout)\r\n\nWHO Technical Report Series, #986, Annex 2 (throughout)\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\n\n\n\n7 CFR Part 331 (throughout)\r\n\n9 CFR Part 121 (throughout)\r\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 7 (throughout)\r\n\n21 CFR Part 58 (throughout)\r\n\n21 CFR Part 117 (throughout)\r\n\n21 CFR Part 211 (throughout)\r\n\n21 CFR Part 212 (throughout)\r\n\n21 CFR Part 225 (throughout)\r\n\n21 CFR Part 226 (throughout)\r\n\n21 CFR Part 312 (throughout)\r\n\n21 CFR Part 606 (throughout)\r\n\n21 CFR Part 810 (throughout)\r\n\n21 CFR Part 812 (throughout)\r\n\n21 CFR Part 820 (throughout)\r\n\n29 CFR Part 1910.134 (c)\r\n\n29 CFR Part 1910.1030 (throughout)\r\n\n29 CFR Part 1910.1200 (e)\r\n\n29 CFR Part 1910.1450 (throughout)\r\n\n40 CFR Part 262.214\r\n\n42 CFR Part 73 (throughout)\r\n\n42 CFR Part 93.300\u20135\r\n\n42 CFR Part 493.1200\r\n\n42 CFR Part 493.1232\r\n\n42 CFR Part 493.1239\r\n\n42 CFR Part 493.1251\r\n\n42 CFR Part 493.1291 (j)\r\n\n42 CFR Part 493.1773 (c\u2013d)\r\n\n45 CFR Part 160.310\r\n\n45 CFR Part 164 (throughout)\r\n\n61 FR 38806 (throughout)\r\n\nA2LA C211 (throughout)\r\n\nA2LA C223 (throughout)\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\nAAVLD Requirements for an AVMDL (throughout)\r\n\nACMG Technical Standards for Clinical Genetics Laboratories (throughout)\r\n\nAIHA-LAP Policies 2022 Appendix H5.8\r\n\nASTM E1188-11 3.5.2\r\n\nASTM E1492-11 4.3.3.3 and 4.4.4\r\n\nASTM E1578-18 D-1-2\r\n\nBRC GSFS, Issue 8, 3.1.2\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nBRC GSFS, Issue 8, 5.6.2.2\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual (throughout)\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)\r\n\nCJIS Security Policy (throughout)\r\n\nCLSI QMS22 (throughout)\r\n\nEPA 815-R-05-004 (throughout)\r\n\nEPA ERLN Laboratory Requirements (throughout)\r\n\nEPA QA\/G-5 (throughout)\r\n\nE.U. Commission Directive 2003\/94\/EC (throughout)\r\n\nFDA Hazard Analysis Critical Control Point (throughout)\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\nIFS Food 7, Part 2 (throughout)\r\n\nIFS PACsecure 2, Part 2 (throughout)\r\n\nISO 15189:2012 (throughout)\r\n\nISO\/IEC 17025:2017 (throughout)\r\n\nISO\/TS 22002-1:2009 (throughout)\r\n\nISO\/TS 22002-4:2013 (throughout)\r\n\nISO\/TS 22002-6:2016 (throughout)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5 (throughout)\r\n\nOECD GLP Principles 8\r\n\nOSHA 1910.1020 (throughout)\r\n\nOSHA 1910.1200(b)(3)\r\n\nOSHA 1910.1450(h)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\nSQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nUSDA Data and Instrumentation for PDP (throughout)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines (throughout)\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3\r\n\nUSDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\nWADA International Standard for Laboratories (ISL) (throughout)\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\r\n\nWHO Technical Report Series, #961, Annex 13 (throughout)\r\n\nWHO Technical Report Series, #986, Annex 2 (throughout)\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.2 The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\n\n\n\n21 CFR Part 1.1154 (c)\r\n\n21 CFR Part 820.40 (a)\r\n\n42 CFR Part 493.1251 (e)\r\n\nA2LA C211 4.3\r\n\nAAVLD Requirements for an AVMDL Sec. 4.3\r\n\nASTM E1578-18 D-1-3\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nEPA 815-R-05-004 Chap. III, Sec. 11\r\n\nEPA ERLN Laboratory Requirements 4.2.4.2\r\n\nEPA QA\/G-5 2.1.9\r\n\nISO 15189:2012 4.3\r\n\nISO 15189:2012 5.5.3\r\n\nISO 15189:2012 5.9.3\r\n\nISO\/IEC 17025:2017 7.5.2\r\n\nISO\/IEC 17025:2017 8.3.2\r\n\nUSDA Administrative Procedures for the PDP 5.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.5\n\n\n7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.\n\n\nASTM E1578-18 D-1-4\n\n7.4 The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1151\r\n\n21 CFR Part 1.1152 (e)\r\n\n21 CFR Part 106.91 (c)\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.315\r\n\n21 CFR Part 111.320\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.160\r\n\n21 CFR Part 212.20 (c)\r\n\n21 CFR Part 212.60 (c)\r\n\n21 CFR Part 226.58 (e)\r\n\n21 CFR Part 820.250 (b)\r\n\n42 CFR Part 493.43 (c)\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nASTM E1578-18 D-1-5\r\n\nBRC GSFS, Issue 8, 5.6.1.1\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.3\r\n\nCodex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\nCodex Alimentarius CXS 234-1999 (throughout)\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 5\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\nIFS Food 7, Part 2, 5.5.2\r\n\nIFS Food 7, Part 2, 5.6.2\r\n\nIFS PACsecure 2, Part 2, 5.5.2\r\n\nIFS PACsecure 2, Part 2, 5.6.2\r\n\nISO\/IEC 17025:2017 6.5\r\n\nISO\/IEC 17025:2017 7.2.1.3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)\r\n\nUSDA Administrative Procedures for the PDP 8.4\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1\r\n\nWHO Technical Report Series, #986, Annex 2, 15.14\n\n\n7.5 The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1151\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.320\r\n\n21 CFR Part 212.20 (c)\r\n\n21 CFR Part 212.70 (b)\r\n\nA2LA C211 5.4.5\r\n\nA2LA C223 5.4\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.4\r\n\nABFT Accreditation Manual Sec. G-12, -14, and -15\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C10\r\n\nACMG Technical Standards for Clinical Genetics Laboratories F7.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4\r\n\nCodex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\nCodex Alimentarius CXS 234-1999 (throughout)\r\n\nEPA QA\/G-5 2.2.4\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\nISO\/IEC 17025:2017 7.2.2.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\nUSDA Administrative Procedures for the PDP 8.4\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6\r\n\nWHO Technical Report Series, #961, Annex 13, 10.1\r\n\nWHO Technical Report Series, #986, Annex 2, 4.11\r\n\nWHO Technical Report Series, #986, Annex 2, 15.13\n\n\n7.6 The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\n\n\n\n7 CFR Part 331.10\r\n\n7 CFR Part 331.15\r\n\n9 CFR Part 2.32\r\n\n9 CFR Part 121.10 \r\n\n9 CFR Part 121.15 \r\n\n10 CFR Part 30.34 (j-3)\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 11.10 (i)\r\n\n21 CFR Part 58.29\r\n\n21 CFR Part 211.25\r\n\n21 CFR Part 225.10\r\n\n21 CFR Part 226.10\r\n\n21 CFR Part 226.40\r\n\n21 CFR Part 820.25\r\n\n29 CFR Part 1910.134 (c)\r\n\n29 CFR Part 1910.1030 (g-2)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n29 CFR Part 1910.1200 (h)\r\n\n29 CFR Part 1910.1450 (f)\r\n\n40 CFR Part 262.207\r\n\n40 CFR Part 262.210\u201312\r\n\n42 CFR Part 73.10\r\n\n42 CFR Part 73.15\r\n\n42 CFR Part 493.43 (c)\r\n\n42 CFR Part 493.1235\r\n\n42 CFR Part 493.1251\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 417.5\r\n\nA2LA C211 5.2\r\n\nA2LA C223 5.2\r\n\nA2LA C223 5.7\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\nAAVLD Requirements for an AVMDL Appendix 1\r\n\nABFT Accreditation Manual Sec. B\r\n\nACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.4\r\n\nAIHA-LAP Policies 2022 (throughout)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASTM E1578-18 C-3-5\r\n\nASTM E1578-18 D-1-6\r\n\nASTM E1578-18 E-1-6\r\n\nBRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nCAP Laboratory Accreditation Manual\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCLSI QMS22 (throughout)\r\n\nE.U. Annex 11-2\r\n\nE.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\nEPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 1\r\n\nEPA QA\/G-5 2.1.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.1\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.1\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nISO 15189:2012 4.1.2.1\r\n\nISO 15189:2012 5.1.6\r\n\nISO 15189:2012 5.1.9\r\n\nISO\/IEC 17025:2017 6.2.2\r\n\nISO\/IEC 17025:2017 6.2.3\r\n\nISO\/IEC 17025:2017 6.2.5\r\n\nISO\/IEC 17025:2017 6.2.6\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nOECD GLP Principles 1.1.2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\n\n\n7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n\n\nASTM E1578-18 D-1-7\n\n7.8 The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\n\n\nAAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5\r\nEPA ERLN Laboratory Requirements 4.10.6\n\n7.9 The system shall support the addition of accurate cross-references and page numbers to new documents.\n\n\nAAVLD Requirements for an AVMDL Sec. 4.3.4\n\n7.10 The system shall be capable of uniquely identifying documents created in and added to the system.\n\n\nAPHL 2019 LIS Project Management Guidebook\r\n\n\n7.11 The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\n\n\n\n8. Resource management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n9 CFR Part 2.32\r\n\n10 CFR Part 20.2103\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 110.10 (c)\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.10\r\n\n29 CFR Part 1910.120\r\n\n29 CFR Part 1910.134 (m)\r\n\n29 CFR Part 1910.1030 (h-1)\r\n\n29 CFR Part 1910.1450 (j)\r\n\n40 CFR Part 262.207\r\n\nA2LA C211 4.13.2.3\r\n\nA2LA C223 5.2\r\n\nA2LA C223 5.7\r\n\nACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nBRC GSFS, Issue 8, 7.3.1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.2.3\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nEPA QA\/G-5 2.1.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.1\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.1\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nNIST 800-53, Rev. 5, AT-3 and -4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOSHA 1910.1020 (throughout)\r\n\nOSHA 1910.1200(b)(3) and (h)\r\n\nOSHA 1910.1450 (throughout)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nUSDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\r\n\nWHO Technical Report Series, #996, Annex 5, 8.1\n\n\n8.1 The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\n\n\n\n21 CFR Part 820.198\r\n\n42 CFR Part 493.1233\r\n\nBRC GSFS, Issue 8, 3.10.1\u20132\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21\r\n\nIFS Food 7, Part 2, 5.8\r\n\nIFS PACsecure 2, Part 2, 5.8\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)\r\n\nWADA International Standard for Laboratories (ISL) 5.3.10\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\n\n\n8.2 The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.\n\n\n\n5 CFR Part 930.301\r\n\n7 CFR Part 331.15\r\n\n9 CFR Part 121.15\r\n\n21 CFR Part 120.12\r\n\nhttps:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123 21 CFR Part 123.10]\r\n\n21 CFR Part 211.25\r\n\n29 CFR Part 1910.1450 (f)\r\n\n42 CFR Part 73.15\r\n\nA2LA C223 5.2\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3\r\n\nASTM E1578-18 E-1-1\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nCJIS Security Policy 5.2.1\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nNIST 800-53, Rev. 5, AT-2 and AT-3\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Sampling Procedures for PDP 6.1.2\u20133\r\n\nWHO Technical Report Series, #986, Annex 2, 10\n\n\n8.3 The system shall allow training sessions and reviews to be scheduled for personnel.\n\n\n\n5 CFR Part 930.301\r\n\n29 CFR Part 1910.1450 (f)\r\n\nABFT Accreditation Manual Sec. B\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7\r\n\nASTM E1578-18 E-1-2\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.4 The system should provide access to relevant training materials to personnel attending training sessions.\n\n\n\n5 CFR Part 930.301\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 110.10 (c)\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.10\r\n\n29 CFR Part 1910.1450 (f)\r\n\n40 CFR Part 262.207\r\n\nA2LA C223 5.2\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5\r\n\nASTM E1578-18 E-1-3\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.2.3\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nEPA QA\/G-5 2.1.8\r\n\nE.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nISO 15189:2012 5.1.9\r\n\nNIST 800-53, Rev. 5, AT-2\u2013AT-4\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e\r\n\nUSDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (e)\r\n\nWHO Technical Report Series, #986, Annex 2, 9.4\r\n\nWHO Technical Report Series, #986, Annex 2, 10\n\n\n8.5 The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\n\n\n\nABFT Accreditation Manual Sec. B\r\n\nASTM E1578-18 E-1-4\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\n\n\n8.6 The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\n\n\n\nASTM E1578-18 E-1-5\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nNIST 800-53, Rev. 5, AT-2 and AT-3\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.7 The system should be able to produce a training matrix of personnel.\n\n\n\n7 CFR Part 331.15\r\n\n9 CFR Part 121.10 \r\n\n9 CFR Part 121.15 \r\n\n21 CFR Part 11.10 (i)\r\n\n21 CFR Part 58.29\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 211.25\r\n\n21 CFR Part 225.10\r\n\n21 CFR Part 226.10\r\n\n21 CFR Part 226.40\r\n\n21 CFR Part 820.25\r\n\n29 CFR Part 1910.1030 (g-2)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n29 CFR Part 1910.1200 (h)\r\n\n29 CFR Part 1910.1450 (e)\r\n\n42 CFR Part 73.10\r\n\n42 CFR Part 73.15\r\n\n42 CFR Part 493.43 (c)\r\n\n42 CFR Part 493.1235\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nA2LA C223 5.2\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\nAAVLD Requirements for an AVMDL Appendix 1\r\n\nABFT Accreditation Manual Sec. B\r\n\nAIHA-LAP Policies 2022 (various parts)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASTM E1578-18 C-3-5\r\n\nASTM E1578-18 D-1-6\r\n\nASTM E1578-18 E-1-6\r\n\nBRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nE.U. Annex 11-2\r\n\nEPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 1\r\n\nEPA QA\/G-5 2.1.8\r\n\nISO 15189:2012 4.1.2.1\r\n\nISO 15189:2012 5.1.6\r\n\nISO 15189:2012 5.1.9\r\n\nISO\/IEC 17025:2017 6.2.2\r\n\nISO\/IEC 17025:2017 6.2.3\r\n\nISO\/IEC 17025:2017 6.2.5\r\n\nISO\/IEC 17025:2017 6.2.6\r\n\nOECD GLP Principles 1.1.2\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\n\n\n8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n\n\n\n9. Compliance management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17 \r\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1251 (d)\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nASTM E1578-18 C-4-7\r\n\nASTM E1578-18 E-2-1\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Annex 11-9\r\n\nE.U. Annex 11-14\r\n\nOECD GLP Principles 8.3.5\r\n\nUSDA Data and Instrumentation for PDP 8.1.3\n\n\n9.1 The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-2\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCJIS Security Policy Appendix G.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Annex 11-9\r\n\nE.U. Annex 11-12.4\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nNIST 800-53, Rev. 5, AC-2(4) and AC-6(9)\r\n\nNIST 800-53, Rev. 5, AU-2 and AU-3\r\n\nNIST 800-53, Rev. 5, CM-5(1)\r\n\nOECD GLP Principles 8.3.5\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n9.2 The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1274\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-3\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCLSI QMS22 2.2.3.2\r\n\nCLSI QMS22 2.4.3\r\n\nE.U. Annex 11-12.4\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nNIST 800-53, Rev. 5, AU-3 and AU-8\r\n\nOECD GLP Principles 8.3.5\r\n\nUSDA Data and Instrumentation for PDP 8.1.4\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.3 The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-4\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nICH GCP 4.9.0 and 4.9.3\r\n\nNIST 800-53, Rev. 5, AU-3\r\n\nOECD GLP Principles 8.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.4 The system's audit trail shall document the previous and current value of a modified field.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1251 (d)\r\n\n45 CFR Part 164.310\r\n\nASTM E1578-18 E-2-5\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nE.U. Annex 11-14\r\n\nOECD GLP Principles 8.3.5\n\n\n9.5 The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\n\n\n21 CFR Part 11.70\r\nE.U. Annex 11-14\n\n9.6 The system shall prevent a user from copying and pasting the electronic signature of another user.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 58.130 (e)\r\n\n42 CFR Part 493.1274 (d)\r\n\nE.U. Annex 11-9\r\n\nNIST 800-53, Rev. 5, AU-6 and AU-12\r\n\nOECD GLP Principles 8.3.5\n\n\n9.7 The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\n\n\n\n10. Instrument and equipment management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-3-1\n\n10.1 The system should provide a means for tracking usage of laboratory equipment and instruments.\n\n\nASTM E1578-18 E-3-2\n\n10.2 The system shall provide a means for planning the use of and reserving equipment and instruments.\n\n\nASTM E1578-18 E-3-3\n\n10.3 The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\n\n\nASTM E1578-18 E-3-4\n\n10.4 The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\n\n\nASTM E1578-18 E-3-5\n\n10.5 The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\n\n\nASTM E1578-18 E-3-6\n\n10.6 The system shall be able to group instruments together in specific ways, including by type and laboratory location.\n\n\n\n21 CFR Part 110.40 (f)\r\n\n21 CFR Part 211.67\u201368\r\n\n21 CFR Part 211.160 (b-4)\r\n\n21 CFR Part 212.30 (b)\r\n\n21 CFR Part 212.60 (e)\r\n\n21 CFR Part 225.30 (b-4)\r\n\n21 CFR Part 606.60\r\n\n21 CFR Part 820.70 (g)\r\n\n21 CFR Part 820.72\r\n\n42 CFR Part 493.1252 (b-3)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.5.2\r\n\nA2LA C223 5.5\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5\r\n\nABFT Accreditation Manual Sec. E-20\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1\r\n\nAIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\nASTM E1578-18 E-3-7\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.6.1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nISO 15189:2012 5.3.1.4\r\n\nISO\/IEC 17025:2017 6.4.7\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nISO\/TS 22002-4:2013, 4.7.1\r\n\nISO\/TS 22002-6:2016, 4.7\r\n\nNIST 800-53, Rev. 5, MA-2 and MA-2(2)\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Data and Instrumentation for PDP 5.2\r\n\nUSDA Data and Instrumentation for PDP 6\r\n\nWADA International Standard for Laboratories (ISL) 5.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 13.5\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\n\n\n\n21 CFR Part 225.30 (b-4)\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5.9\r\n\nASTM E1578-18 E-3-8\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.8 The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\n\n\n\n21 CFR Part 211.160 (b-4)\r\n\nA2LA C211 5.5.7\r\n\nA2LA C223 5.6\r\n\nABFT Accreditation Manual Sec. E-21\r\n\nASTM E1578-18 E-3-9\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nCLSI QMS22 2.1.2.1\r\n\nIFS Food 7, Part 2, 5.4.3\r\n\nIFS PACsecure 2, Part 2, 5.4.3\r\n\nISO 15189:2012 5.3.1.5\r\n\nISO\/IEC 17025:2017 6.4.9\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)\r\n\nWHO Technical Report Series, #986, Annex 2, 13.10\n\n\n10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.\n\n\n\n21 CFR Part 111.117\r\n\n21 CFR Part 820.72 (b-2)\r\n\nASTM E1578-18 E-3-10\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nNIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\n\n\n\n21 CFR Part 820.72 (b-1)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.6.2.1\r\n\nA2LA C223 5.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.6.1\u20132\r\n\nAIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nISO\/IEC 17025:2017 6.5\r\n\nISO\/TS 22002-4:2013, 4.7.1\r\n\nISO\/TS 22002-6:2016, 4.7\r\n\nOECD GLP Principles 4.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.2\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)\r\n\nUSDA Data and Instrumentation for PDP 6.1\n\n\n10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\n\n\nASTM E1578-18 E-3-11\n\n10.12 The system shall support the use of predefined intervals when calculating instrument event dates.\n\n\n\n21 CFR Part 110.40 (f)\r\n\n21 CFR Part 211.105 (b)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.5.4 and 5.5.5\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5.4\u20135\r\n\nASTM E1578-18 E-3-12\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1\r\n\nIFS Food 7, Part 2, 5.4.1\r\n\nIFS PACsecure 2, Part 2, 5.4.1\r\n\nISO 15189:2012 5.3.1.7\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nISO\/IEC 17025:2017 6.4.13\r\n\nNIST 800-53, Rev. 5, CM-8\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\nUSDA Administrative Procedures for the PDP 7.2\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4\r\n\nWHO Technical Report Series, #961, Annex 13, 6.1\n\n\n10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\n\n\nASTM E1578-18 E-3-13\n\n10.14 The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\n\n\n\n10 CFR Part 20.2103\r\n\n21 CFR Part 58.63\r\n\n21 CFR Part 111.117\r\n\n21 CFR Part 211.67\u201368\r\n\n21 CFR Part 211.160 (b-4)\r\n\n21 CFR Part 211.182\r\n\n21 CFR Part 211.194 (d)\r\n\n21 CFR Part 212.30 (b)\r\n\n21 CFR Part 212.60 (e)\r\n\n21 CFR Part 820.70 (g)\r\n\n21 CFR Part 820.72\r\n\n42 CFR Part 493.1254\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 4.13.2.1\r\n\nA2LA C211 5.5.2\r\n\nA2LA C211 5.10.4\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5\r\n\nABFT Accreditation Manual Sec. E-20 and -23\r\n\nABFT Accreditation Manual Sec. F-1 and I-1\r\n\nAIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\nASTM E1578-18 E-3-14\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.2.1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nISO 15189:2012 5.3.1.4\r\n\nISO\/IEC 17025:2017 6.4.4\r\n\nNIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 4.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Data and Instrumentation for PDP 5.4\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c\r\n\nWADA International Standard for Laboratories (ISL) 5.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 15.46\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.15 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\n\n\n\n11. Batch and lot management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 58.105 (a)\r\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nASTM E1578-18 E-4-1\r\n\nEPA ERLN Laboratory Requirements 3.3\r\n\nEPA ERLN Laboratory Requirements 4.10.1\r\n\nOECD GLP Principles 6.2\n\n\n11.1 The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\n\n\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nASTM E1578-18 E-4-2\r\n\nEPA ERLN Laboratory Requirements 4.10.1\n\n\n11.2 The system shall maintain the links between component parts of a batch and track the batch throughout the system.\n\n\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 820.65\r\n\nASTM E1578-18 E-4-3\n\n\n11.3 The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\n\n\nASTM E1578-18 E-4-4\n\n11.4 The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\n\n\nE.U. Annex 11-15\n\n11.5 The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\n\n\n\n12. Scheduled event management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 129.80 (g)\r\nASTM E1578-18 E-5-1\r\nUSDA Sampling Procedures for PDP 5.6\u20137\n\n12.1 The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.\n\n\n21 CFR Part 212.61 (a)\r\n21 CFR Part 211.166 (b)\r\nASTM E1578-18 E-5-2\n\n12.2 The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.\n\n\nASTM E1578-18 E-5-3\n\n12.3 The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\n\n\nASTM E1578-18 E-5-4\n\n12.4 The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).\n\n\nASTM E1578-18 E-5-5\n\n12.5 The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\n\n\n\n13. Instrument data capture and control \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-6-1\n\n13.1 The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\n\n\nASTM E1578-18 E-6-2\n\n13.2 The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\n\n\nASTM E1578-18 E-6-3\n\n13.3 The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\n\n\nASTM E1578-18 E-6-4\n\n13.4 The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\n\n\nASTM E1578-18 E-6-5\n\n13.5 The system should be able to accept the results uploaded from an interfaced instrument.\n\n\nASTM E1578-18 E-6-6\n\n13.6 The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\n\n\nASTM E1578-18 E-6-7\n\n13.7 The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\n\n\nASTM E1578-18 E-6-8\n\n13.8 The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\n\n\n\n14. Standard and reagent management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 58.83\r\n\n29 CFR Part 1910.1200 (g)\r\n\n29 CFR Part 1910.1450 (h)\r\n\n42 CFR Part 493.1252 (c)\r\n\nABFT Accreditation Manual Sec. E-17\r\n\nASTM E1578-18 E-7-1\r\n\nISO 15189:2012 5.3.2.4\u20135\r\n\nOECD GLP Principles 4.4\n\n\n14.1 The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\n\n\n\n7 CFR Part 331.3\r\n\n9 CFR Part 121.3\r\n\n21 CFR Part 312.58 (b)\r\n\n42 CFR Part 73.3\u20134 (c)\r\n\nASTM E1578-18 E-7-2\r\n\nEPA ERLN Laboratory Requirements 4.1.12\r\n\nISO 15189:2012 5.3.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 12.20\n\n\n14.2 The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\n\n\nASTM E1578-18 E-7-3\r\nISO 15189:2012 5.3.2.4\n\n14.3 The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\n\n\nASTM E1578-18 E-7-4\r\nISO 15189:2012 5.3.2.4\n\n14.4 The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\n\n\nASTM E1578-18 E-7-5\r\nISO 15189:2012 5.3.2.4\n\n14.5 The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\n\n\n\n15. Inventory management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-8-1\r\nCAP Laboratory Accreditation Manual\r\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples and specimens.\n\n\n\n21 CFR Part 212.60 (d)\r\n\nASTM E1578-18 E-8-2\r\n\nCLSI QMS22 2.1.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.2 The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\n\n\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.101\r\n\n21 CFR Part 212.60 (d)\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 606.120 (b)\r\n\n29 CFR Part 1910.1030 (g)\r\n\n29 CFR Part 1910.1096 (e-6)\r\n\n29 CFR Part 1910.1200 (f-6) and (f-10)\r\n\n40 CFR Part 262.206\r\n\nASTM E1578-18 E-8-3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOSHA 1910.1200(b)(3) and (f)\r\n\nOSHA 1910.1450(h)\r\n\nWHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41\r\n\nWHO Technical Report Series, #986, Annex 2, 15.10\u201312\n\n\n15.3 The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\n\n\n\n21 CFR Part 117.420\r\n\n21 CFR Part 212.40 (c)\r\n\n21 CFR Part 820.50\r\n\nA2LA C211 4.6\r\n\nASTM E1578-18 E-8-4\r\n\nBRC GSFS, Issue 8, 3.5.1.4\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5\r\n\nIFS Food 7, Part 2, 4.4.1\r\n\nIFS PACsecure 2, Part 2, 4.4.1\r\n\nISO\/TS 22002-1:2009, 9.2\r\n\nISO\/TS 22002-4:2013, 4.6.2\r\n\nISO\/TS 22002-6:2016, 4.6.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.4.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)\r\n\nUSDA Administrative Procedures for the PDP 7.1\r\n\nWHO Technical Report Series, #961, Annex 13, 7.1 and 7.3\r\n\nWHO Technical Report Series, #986, Annex 2, 14.8\n\n\n15.4 The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\n\n\n\n21 CFR Part 211.196\r\n\n21 CFR Part 212.90\r\n\n21 CFR Part 225.110\r\n\n21 CFR Part 606.165\r\n\n29 CFR Part 1910.1450 Appendix A (I)\r\n\nA2LA C211 4.6\r\n\nASTM E1578-18 E-8-5\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5\n\n\n15.5 The system should provide a means for accurately recording the receipt, approval, distribution, and disposal of materials.\n\n\n\n21 CFR Part 211.82 (b)\r\n\n21 CFR Part 211.84 (a)\r\n\n21 CFR Part 211.89\r\n\n21 CFR Part 211.110 (d)\r\n\n21 CFR Part 211.142 (a)\r\n\n21 CFR Part 212.40 (c)\r\n\nASTM E1578-18 E-8-6\r\n\nWHO Technical Report Series, #986, Annex 2, 12.18\n\n\n15.6 The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\n\n\n\n21 CFR Part 211.89\r\n\n21 CFR Part 211.110 (d)\r\n\n42 CFR Part 493.1252 (d)\r\n\nASTM E1578-18 E-8-7\n\n\n15.7 The system should allow authorized personnel to retire faulty or poor quality materials from use.\n\n\n\n21 CFR Part 211.89\r\nASTM E1578-18 E-8-8\n\n\n15.8 The system shall clearly designate a standard or reagent as being disposed or consumed.\n\n\n\n16. Investigation and quality management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 312.62 (b)\r\n21 CFR Part 812.140 (a-3)\n\n16.1 The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\n\n\n\n21 CFR Part 312.57 (a)\r\n\n21 CFR Part 312.62 (a)\r\n\n21 CFR Part 606.165\r\n\n21 CFR Part 812.140 (a-2) and (b-2)\n\n\n16.2 The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\n\n\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 58.81 (a)\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.111\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 211.194\r\n\n21 CFR Part 606.171\r\n\n42 CFR Part 493.1253 (b-2)\r\n\nA2LA C211 5.4\r\n\nABFT Accreditation Manual C-16\r\n\nABFT Accreditation Manual F-2\r\n\nABFT Accreditation Manual J-3\r\n\nASTM E1578-18 E-9-1\r\n\nBRC GSFS, Issue 8, 5.6.2.3\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nCLSI QMS22 2.2.2.2\r\n\nEPA ERLN Laboratory Requirements 3.3\r\n\nEPA QA\/G-5 2.2.4\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\nISO\/IEC 17025:2017 7.2.1.7\r\n\nISO\/IEC 17025:2017 7.2.2.1\r\n\nISO\/IEC 17025:2017 7.10.2\r\n\nISO\/IEC 17025:2017 8.7.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 7.3\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)\r\n\nUSDA Administrative Procedures for the PDP 8.2.2\r\n\nWADA International Standard for Laboratories (ISL) 5.3.6\r\n\nWHO Technical Report Series, #986, Annex 2, 16.3\n\n\n16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\n\n\n42 CFR Part 493.1282\r\nASTM E1578-18 E-9-2\r\nE.U. Commission Reg. No. 2073\/2005 Article 9\n\n16.4 The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\n\n\n\n21 CFR Part 606.100 (c)\r\n\n42 CFR Part 493.1282\r\n\nASTM E1578-18 E-9-3\r\n\nCLSI QMS22 2.1.2.1\r\n\nCLSI QMS22 2.2.2.3\r\n\nEPA QA\/G-5 2.2.10\r\n\nWHO Technical Report Series, #986, Annex 2, 17.12\r\n\nWHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.5 The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\n\n\n\n10 CFR Part 30.34 (g)\r\n\n21 CFR Part 112.147\r\n\n21 CFR Part 225.58 (d)\r\n\n21 CFR Part 225.158\r\n\n21 CFR Part 606.100 (c)\r\n\n21 CFR Part 820.100\r\n\n42 CFR Part 493.1282\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nA2LA C211 4.9 and 4.11\r\n\nASTM E1578-18 E-9-4\r\n\nBRC GSFS, Issue 8, 3.4.3\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCLSI QMS22 2.6.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nFDA Hazard Analysis Critical Control Point Principle 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5, IR-5\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\nWADA International Standard for Laboratories (ISL) 5.3.9\r\n\nWHO Technical Report Series, #961, Annex 13, 11.1\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\r\n\nWHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\n\n\n\n21 CFR Part 225.58 (d)\r\n\n21 CFR Part 225.158\r\n\n42 CFR Part 493.1282\r\n\n42 CFR Part 493.1289\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nA2LA C211 4.8 and 4.11\r\n\nASTM E1578-18 E-9-5\r\n\nBRC GSFS, Issue 8, 3.4.3\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.3.4\r\n\nCJIS Security Policy Appendix G.7\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nFDA Hazard Analysis Critical Control Point Principle 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5, AU-6(1)\r\n\nNIST 800-53, Rev. 5, IR-4(1) and IR-5\r\n\nNIST 800-53, Rev. 5, SI-2 and SI-4\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\n\n\n16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\n\n\nASTM E1578-18 E-9-6\n\n16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\n\n\n9 CFR Part 2.35\n\n16.9 The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#11._Batch_and_lot_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#11._Batch_and_lot_management<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 2 May 2022, at 22:08.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2,552 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","294df292ed93e358a9df3501bb3de637_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Maintaining_Laboratory_Workflow_and_Operations rootpage-LII_LIMSpec_Maintaining_Laboratory_Workflow_and_Operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Maintaining Laboratory Workflow and Operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"7._Document_and_records_management\">7. Document and records management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/part-20\" target=\"_blank\">10 CFR Part 20 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.213\u201314<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(e) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.1<\/b> The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.214<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.300\" target=\"_blank\">42 CFR Part 93.300\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1773\" target=\"_blank\">42 CFR Part 493.1773 (c\u2013d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/160.310\" target=\"_blank\">45 CFR Part 160.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 Appendix H5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.2<\/b> The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.3<\/b> The system shall be able to clearly provide the most current version of a document and archive prior versions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.4<\/b> The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.91 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.14<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.5<\/b> The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-12, -14, and -15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.13<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.6<\/b> The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.10\" target=\"_blank\">7 CFR Part 331.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (j-3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.210\" target=\"_blank\">40 CFR Part 262.210\u201312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.7<\/b> The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.8<\/b> The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.9<\/b> The system shall support the addition of accurate cross-references and page numbers to new documents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.10<\/b> The system shall be capable of uniquely identifying documents created in and added to the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>7.11<\/b> The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"8._Resource_management\">8. Resource management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (m)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-3 and -4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.1<\/b> The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.198\" target=\"_blank\">21 CFR Part 820.198<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1233\" target=\"_blank\">42 CFR Part 493.1233<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.10.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.2<\/b> The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123<\/a> 21 CFR Part 123.10]<br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.3<\/b> The system shall allow training sessions and reviews to be scheduled for personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.4<\/b> The system should provide access to relevant training materials to personnel attending training sessions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2\u2013AT-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.5<\/b> The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.6<\/b> The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.7<\/b> The system should be able to produce a training matrix of personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (various parts)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.8<\/b> The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"9._Compliance_management\">9. Compliance management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.1<\/b> The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-2 and AU-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.2<\/b> The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3 and AU-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.3<\/b> The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.4<\/b> The system's audit trail shall document the previous and current value of a modified field.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.5<\/b> The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>9.6<\/b> The system shall prevent a user from copying and pasting the electronic signature of another user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6 and AU-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.7<\/b> The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"10._Instrument_and_equipment_management\">10. Instrument and equipment management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.1<\/b> The system should provide a means for tracking usage of laboratory equipment and instruments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.2<\/b> The system shall provide a means for planning the use of and reserving equipment and instruments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.3<\/b> The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.4<\/b> The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.5<\/b> The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.6<\/b> The system shall be able to group instruments together in specific ways, including by type and laboratory location.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.60\" target=\"_blank\">21 CFR Part 606.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (b-3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2 and MA-2(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.7<\/b> The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.8<\/b> The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.9<\/b> The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.10<\/b> The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.6.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.11<\/b> The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.12<\/b> The system shall support the use of predefined intervals when calculating instrument event dates.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.4 and 5.5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.13<\/b> The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-13<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.14<\/b> The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.63\" target=\"_blank\">21 CFR Part 58.63<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.182\" target=\"_blank\">21 CFR Part 211.182<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1254\" target=\"_blank\">42 CFR Part 493.1254<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20 and -23<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. F-1 and I-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.46<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.15<\/b> The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"11._Batch_and_lot_management\">11. Batch and lot management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.1<\/b> The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.2<\/b> The system shall maintain the links between component parts of a batch and track the batch throughout the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.65\" target=\"_blank\">21 CFR Part 820.65<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.3<\/b> The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>11.4<\/b> The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-15<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>11.5<\/b> The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"12._Scheduled_event_management\">12. Scheduled event management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.6\u20137<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.1<\/b> The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.2<\/b> The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.3<\/b> The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.4<\/b> The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.5<\/b> The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"13._Instrument_data_capture_and_control\">13. Instrument data capture and control<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.1<\/b> The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.2<\/b> The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.3<\/b> The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.4<\/b> The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.5<\/b> The system should be able to accept the results uploaded from an interfaced instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.6<\/b> The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.7<\/b> The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.8<\/b> The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"14._Standard_and_reagent_management\">14. Standard and reagent management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.83\" target=\"_blank\">21 CFR Part 58.83<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>14.1<\/b> The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.3\" target=\"_blank\">7 CFR Part 331.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.3\" target=\"_blank\">9 CFR Part 121.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.3\" target=\"_blank\">42 CFR Part 73.3\u20134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.20<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>14.2<\/b> The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.3<\/b> The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.4<\/b> The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.5<\/b> The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"15._Inventory_management\">15. Inventory management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>15.1<\/b> The system should be capable of accurately tracking the specific quantities of received and consumed test samples and specimens.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.2<\/b> The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (f-6) and (f-10)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.206\" target=\"_blank\">40 CFR Part 262.206<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.10\u201312<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.3<\/b> The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.50\" target=\"_blank\">21 CFR Part 820.50<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.4<\/b> The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.196\" target=\"_blank\">21 CFR Part 211.196<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.90\" target=\"_blank\">21 CFR Part 212.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 Appendix A (I)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.5<\/b> The system should provide a means for accurately recording the receipt, approval, distribution, and disposal of materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.82\" target=\"_blank\">21 CFR Part 211.82 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.142\" target=\"_blank\">21 CFR Part 211.142 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.6<\/b> The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.7<\/b> The system should allow authorized personnel to retire faulty or poor quality materials from use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.8<\/b> The system shall clearly designate a standard or reagent as being disposed or consumed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"16._Investigation_and_quality_management\">16. Investigation and quality management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.1<\/b> The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-2) and (b-2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.2<\/b> The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.81\" target=\"_blank\">21 CFR Part 58.81 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.171\" target=\"_blank\">21 CFR Part 606.171<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1253\" target=\"_blank\">42 CFR Part 493.1253 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual F-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual J-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.3<\/b> The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.4<\/b> The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.5<\/b> The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.147<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.100\" target=\"_blank\">21 CFR Part 820.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.9 and 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 11.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.6<\/b> The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1289\" target=\"_blank\">42 CFR Part 493.1289<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.8 and 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-4(1) and IR-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2 and SI-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.7<\/b> The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.8<\/b> The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.9<\/b> The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173541\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.104 seconds\nReal time usage: 0.111 seconds\nPreprocessor visited node count: 1035\/1000000\nPost\u2010expand include size: 141529\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 20.237 1 -total\n 11.99% 2.426 1 Template:LIMSpec\/Document_management\n 10.55% 2.135 1 Template:LIMSpec\/Resource_management\n 9.87% 1.998 1 Template:LIMSpec\/Instrument_and_equipment_management\n 9.68% 1.958 1 Template:LIMSpec\/Compliance_management\n 9.13% 1.848 1 Template:LIMSpec\/Batch_and_lot_management\n 9.07% 1.836 1 Template:LIMSpec\/Investigation_and_quality_management\n 8.97% 1.815 1 Template:LIMSpec\/Inventory_management\n 8.81% 1.782 1 Template:LIMSpec\/Scheduled_event_management\n 8.72% 1.764 1 Template:LIMSpec\/Instrument_data_capture_and_control\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11181-0!canonical and timestamp 20221202173541 and revision id 47569. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#11._Batch_and_lot_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#11._Batch_and_lot_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","294df292ed93e358a9df3501bb3de637_images":[],"294df292ed93e358a9df3501bb3de637_timestamp":1670002542,"bff44fcebcd26459117e31bbd8c99ea1_type":"article","bff44fcebcd26459117e31bbd8c99ea1_title":"10. Instrument and equipment management","bff44fcebcd26459117e31bbd8c99ea1_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#10._Instrument_and_equipment_management","bff44fcebcd26459117e31bbd8c99ea1_plaintext":"\n\nLII:LIMSpec\/Maintaining Laboratory Workflow and OperationsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.\n\n7. Document and records management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n7 CFR Part 331 (throughout)\r\n\n9 CFR Part 121 (throughout)\r\n\n10 CFR Part 20 (throughout)\r\n\n21 CFR Part 7 (throughout)\r\n\n21 CFR Part 117 (throughout)\r\n\n21 CFR Part 58 (throughout)\r\n\n21 CFR Part 211 (throughout)\r\n\n21 CFR Part 212 (throughout)\r\n\n21 CFR Part 225 (throughout)\r\n\n21 CFR Part 226 (throughout)\r\n\n21 CFR Part 312 (throughout)\r\n\n21 CFR Part 606 (throughout)\r\n\n21 CFR Part 810 (throughout)\r\n\n21 CFR Part 812 (throughout)\r\n\n21 CFR Part 820 (throughout)\r\n\n29 CFR Part 1910.134 (throughout)\r\n\n29 CFR Part 1910.1030 (throughout)\r\n\n29 CFR Part 1910.1200 (throughout)\r\n\n29 CFR Part 1910.1450 (throughout)\r\n\n40 CFR Part 262.213\u201314\r\n\n42 CFR Part 73 (throughout)\r\n\n42 CFR Part 493.1200\r\n\n42 CFR Part 493.1232\r\n\n42 CFR Part 493.1239\r\n\n42 CFR Part 493.1251\r\n\n42 CFR Part 493.1291 (j)\r\n\n45 CFR Part 164 (throughout)\r\n\n61 FR 38806 (throughout)\r\n\nA2LA C211 4.3\r\n\nA2LA C223 4.13\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\nAAVLD Requirements for an AVMDL (throughout)\r\n\nABFT Accreditation Manual (throughout)\r\n\nASTM E1188-11 3.5.2\r\n\nASTM E1492-11 4.3.3.3 and 4.4.4\r\n\nASTM E1578-18 D-1-1\r\n\nBRC GSFS, Issue 8, 3.1.1\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nBRC GSFS, Issue 8, 5.6.1.1\r\n\nBRC GSFS, Issue 8, 5.6.2.2\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual (throughout)\r\n\nCJIS Security Policy (throughout)\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)\r\n\nEPA 815-R-05-004 (throughout)\r\n\nEPA ERLN Laboratory Requirements (throughout)\r\n\nEPA QA\/G-5 (throughout)\r\n\nE.U. Commission Directive 2003\/94\/EC (throughout)\r\n\nFDA Hazard Analysis Critical Control Point (throughout)\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\nIFS Food 7, Part 2 (throughout)\r\n\nIFS PACsecure 2, Part 2 (throughout)\r\n\nISO 15189:2012 4.3\r\n\nISO 15189:2012 5.5.3\r\n\nISO 15189:2012 5.9.3\r\n\nISO\/IEC 17025:2017 5.3\r\n\nISO\/IEC 17025:2017 5.5\r\n\nISO\/IEC 17025:2017 8.3.2\r\n\nISO\/TS 22002-1:2009 (throughout)\r\n\nISO\/TS 22002-4:2013 (throughout)\r\n\nISO\/TS 22002-6:2016 (throughout)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5 (throughout)\r\n\nOECD GLP Principles 8\r\n\nOSHA 1910.1200(b)(3)\r\n\nOSHA 1910.1450(e) and (h)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\nSQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nUSDA Data and Instrumentation for PDP (throughout)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\nWHO Technical Report Series, #961, Annex 13 (throughout)\r\n\nWHO Technical Report Series, #986, Annex 2 (throughout)\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\n\n\n\n7 CFR Part 331 (throughout)\r\n\n9 CFR Part 121 (throughout)\r\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 7 (throughout)\r\n\n21 CFR Part 58 (throughout)\r\n\n21 CFR Part 117 (throughout)\r\n\n21 CFR Part 211 (throughout)\r\n\n21 CFR Part 212 (throughout)\r\n\n21 CFR Part 225 (throughout)\r\n\n21 CFR Part 226 (throughout)\r\n\n21 CFR Part 312 (throughout)\r\n\n21 CFR Part 606 (throughout)\r\n\n21 CFR Part 810 (throughout)\r\n\n21 CFR Part 812 (throughout)\r\n\n21 CFR Part 820 (throughout)\r\n\n29 CFR Part 1910.134 (c)\r\n\n29 CFR Part 1910.1030 (throughout)\r\n\n29 CFR Part 1910.1200 (e)\r\n\n29 CFR Part 1910.1450 (throughout)\r\n\n40 CFR Part 262.214\r\n\n42 CFR Part 73 (throughout)\r\n\n42 CFR Part 93.300\u20135\r\n\n42 CFR Part 493.1200\r\n\n42 CFR Part 493.1232\r\n\n42 CFR Part 493.1239\r\n\n42 CFR Part 493.1251\r\n\n42 CFR Part 493.1291 (j)\r\n\n42 CFR Part 493.1773 (c\u2013d)\r\n\n45 CFR Part 160.310\r\n\n45 CFR Part 164 (throughout)\r\n\n61 FR 38806 (throughout)\r\n\nA2LA C211 (throughout)\r\n\nA2LA C223 (throughout)\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\nAAVLD Requirements for an AVMDL (throughout)\r\n\nACMG Technical Standards for Clinical Genetics Laboratories (throughout)\r\n\nAIHA-LAP Policies 2022 Appendix H5.8\r\n\nASTM E1188-11 3.5.2\r\n\nASTM E1492-11 4.3.3.3 and 4.4.4\r\n\nASTM E1578-18 D-1-2\r\n\nBRC GSFS, Issue 8, 3.1.2\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nBRC GSFS, Issue 8, 5.6.2.2\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual (throughout)\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)\r\n\nCJIS Security Policy (throughout)\r\n\nCLSI QMS22 (throughout)\r\n\nEPA 815-R-05-004 (throughout)\r\n\nEPA ERLN Laboratory Requirements (throughout)\r\n\nEPA QA\/G-5 (throughout)\r\n\nE.U. Commission Directive 2003\/94\/EC (throughout)\r\n\nFDA Hazard Analysis Critical Control Point (throughout)\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\nIFS Food 7, Part 2 (throughout)\r\n\nIFS PACsecure 2, Part 2 (throughout)\r\n\nISO 15189:2012 (throughout)\r\n\nISO\/IEC 17025:2017 (throughout)\r\n\nISO\/TS 22002-1:2009 (throughout)\r\n\nISO\/TS 22002-4:2013 (throughout)\r\n\nISO\/TS 22002-6:2016 (throughout)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5 (throughout)\r\n\nOECD GLP Principles 8\r\n\nOSHA 1910.1020 (throughout)\r\n\nOSHA 1910.1200(b)(3)\r\n\nOSHA 1910.1450(h)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\nSQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nUSDA Data and Instrumentation for PDP (throughout)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines (throughout)\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3\r\n\nUSDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\nWADA International Standard for Laboratories (ISL) (throughout)\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\r\n\nWHO Technical Report Series, #961, Annex 13 (throughout)\r\n\nWHO Technical Report Series, #986, Annex 2 (throughout)\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.2 The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\n\n\n\n21 CFR Part 1.1154 (c)\r\n\n21 CFR Part 820.40 (a)\r\n\n42 CFR Part 493.1251 (e)\r\n\nA2LA C211 4.3\r\n\nAAVLD Requirements for an AVMDL Sec. 4.3\r\n\nASTM E1578-18 D-1-3\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nEPA 815-R-05-004 Chap. III, Sec. 11\r\n\nEPA ERLN Laboratory Requirements 4.2.4.2\r\n\nEPA QA\/G-5 2.1.9\r\n\nISO 15189:2012 4.3\r\n\nISO 15189:2012 5.5.3\r\n\nISO 15189:2012 5.9.3\r\n\nISO\/IEC 17025:2017 7.5.2\r\n\nISO\/IEC 17025:2017 8.3.2\r\n\nUSDA Administrative Procedures for the PDP 5.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.5\n\n\n7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.\n\n\nASTM E1578-18 D-1-4\n\n7.4 The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1151\r\n\n21 CFR Part 1.1152 (e)\r\n\n21 CFR Part 106.91 (c)\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.315\r\n\n21 CFR Part 111.320\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.160\r\n\n21 CFR Part 212.20 (c)\r\n\n21 CFR Part 212.60 (c)\r\n\n21 CFR Part 226.58 (e)\r\n\n21 CFR Part 820.250 (b)\r\n\n42 CFR Part 493.43 (c)\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nASTM E1578-18 D-1-5\r\n\nBRC GSFS, Issue 8, 5.6.1.1\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.3\r\n\nCodex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\nCodex Alimentarius CXS 234-1999 (throughout)\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 5\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\nIFS Food 7, Part 2, 5.5.2\r\n\nIFS Food 7, Part 2, 5.6.2\r\n\nIFS PACsecure 2, Part 2, 5.5.2\r\n\nIFS PACsecure 2, Part 2, 5.6.2\r\n\nISO\/IEC 17025:2017 6.5\r\n\nISO\/IEC 17025:2017 7.2.1.3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)\r\n\nUSDA Administrative Procedures for the PDP 8.4\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1\r\n\nWHO Technical Report Series, #986, Annex 2, 15.14\n\n\n7.5 The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1151\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.320\r\n\n21 CFR Part 212.20 (c)\r\n\n21 CFR Part 212.70 (b)\r\n\nA2LA C211 5.4.5\r\n\nA2LA C223 5.4\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.4\r\n\nABFT Accreditation Manual Sec. G-12, -14, and -15\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C10\r\n\nACMG Technical Standards for Clinical Genetics Laboratories F7.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4\r\n\nCodex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\nCodex Alimentarius CXS 234-1999 (throughout)\r\n\nEPA QA\/G-5 2.2.4\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\nISO\/IEC 17025:2017 7.2.2.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\nUSDA Administrative Procedures for the PDP 8.4\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6\r\n\nWHO Technical Report Series, #961, Annex 13, 10.1\r\n\nWHO Technical Report Series, #986, Annex 2, 4.11\r\n\nWHO Technical Report Series, #986, Annex 2, 15.13\n\n\n7.6 The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\n\n\n\n7 CFR Part 331.10\r\n\n7 CFR Part 331.15\r\n\n9 CFR Part 2.32\r\n\n9 CFR Part 121.10 \r\n\n9 CFR Part 121.15 \r\n\n10 CFR Part 30.34 (j-3)\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 11.10 (i)\r\n\n21 CFR Part 58.29\r\n\n21 CFR Part 211.25\r\n\n21 CFR Part 225.10\r\n\n21 CFR Part 226.10\r\n\n21 CFR Part 226.40\r\n\n21 CFR Part 820.25\r\n\n29 CFR Part 1910.134 (c)\r\n\n29 CFR Part 1910.1030 (g-2)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n29 CFR Part 1910.1200 (h)\r\n\n29 CFR Part 1910.1450 (f)\r\n\n40 CFR Part 262.207\r\n\n40 CFR Part 262.210\u201312\r\n\n42 CFR Part 73.10\r\n\n42 CFR Part 73.15\r\n\n42 CFR Part 493.43 (c)\r\n\n42 CFR Part 493.1235\r\n\n42 CFR Part 493.1251\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 417.5\r\n\nA2LA C211 5.2\r\n\nA2LA C223 5.2\r\n\nA2LA C223 5.7\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\nAAVLD Requirements for an AVMDL Appendix 1\r\n\nABFT Accreditation Manual Sec. B\r\n\nACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.4\r\n\nAIHA-LAP Policies 2022 (throughout)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASTM E1578-18 C-3-5\r\n\nASTM E1578-18 D-1-6\r\n\nASTM E1578-18 E-1-6\r\n\nBRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nCAP Laboratory Accreditation Manual\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCLSI QMS22 (throughout)\r\n\nE.U. Annex 11-2\r\n\nE.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\nEPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 1\r\n\nEPA QA\/G-5 2.1.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.1\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.1\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nISO 15189:2012 4.1.2.1\r\n\nISO 15189:2012 5.1.6\r\n\nISO 15189:2012 5.1.9\r\n\nISO\/IEC 17025:2017 6.2.2\r\n\nISO\/IEC 17025:2017 6.2.3\r\n\nISO\/IEC 17025:2017 6.2.5\r\n\nISO\/IEC 17025:2017 6.2.6\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nOECD GLP Principles 1.1.2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\n\n\n7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n\n\nASTM E1578-18 D-1-7\n\n7.8 The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\n\n\nAAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5\r\nEPA ERLN Laboratory Requirements 4.10.6\n\n7.9 The system shall support the addition of accurate cross-references and page numbers to new documents.\n\n\nAAVLD Requirements for an AVMDL Sec. 4.3.4\n\n7.10 The system shall be capable of uniquely identifying documents created in and added to the system.\n\n\nAPHL 2019 LIS Project Management Guidebook\r\n\n\n7.11 The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\n\n\n\n8. Resource management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n9 CFR Part 2.32\r\n\n10 CFR Part 20.2103\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 110.10 (c)\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.10\r\n\n29 CFR Part 1910.120\r\n\n29 CFR Part 1910.134 (m)\r\n\n29 CFR Part 1910.1030 (h-1)\r\n\n29 CFR Part 1910.1450 (j)\r\n\n40 CFR Part 262.207\r\n\nA2LA C211 4.13.2.3\r\n\nA2LA C223 5.2\r\n\nA2LA C223 5.7\r\n\nACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nBRC GSFS, Issue 8, 7.3.1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.2.3\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nEPA QA\/G-5 2.1.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.1\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.1\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nNIST 800-53, Rev. 5, AT-3 and -4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOSHA 1910.1020 (throughout)\r\n\nOSHA 1910.1200(b)(3) and (h)\r\n\nOSHA 1910.1450 (throughout)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nUSDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\r\n\nWHO Technical Report Series, #996, Annex 5, 8.1\n\n\n8.1 The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\n\n\n\n21 CFR Part 820.198\r\n\n42 CFR Part 493.1233\r\n\nBRC GSFS, Issue 8, 3.10.1\u20132\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21\r\n\nIFS Food 7, Part 2, 5.8\r\n\nIFS PACsecure 2, Part 2, 5.8\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)\r\n\nWADA International Standard for Laboratories (ISL) 5.3.10\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\n\n\n8.2 The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.\n\n\n\n5 CFR Part 930.301\r\n\n7 CFR Part 331.15\r\n\n9 CFR Part 121.15\r\n\n21 CFR Part 120.12\r\n\nhttps:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123 21 CFR Part 123.10]\r\n\n21 CFR Part 211.25\r\n\n29 CFR Part 1910.1450 (f)\r\n\n42 CFR Part 73.15\r\n\nA2LA C223 5.2\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3\r\n\nASTM E1578-18 E-1-1\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nCJIS Security Policy 5.2.1\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nNIST 800-53, Rev. 5, AT-2 and AT-3\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Sampling Procedures for PDP 6.1.2\u20133\r\n\nWHO Technical Report Series, #986, Annex 2, 10\n\n\n8.3 The system shall allow training sessions and reviews to be scheduled for personnel.\n\n\n\n5 CFR Part 930.301\r\n\n29 CFR Part 1910.1450 (f)\r\n\nABFT Accreditation Manual Sec. B\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7\r\n\nASTM E1578-18 E-1-2\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.4 The system should provide access to relevant training materials to personnel attending training sessions.\n\n\n\n5 CFR Part 930.301\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 110.10 (c)\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.10\r\n\n29 CFR Part 1910.1450 (f)\r\n\n40 CFR Part 262.207\r\n\nA2LA C223 5.2\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5\r\n\nASTM E1578-18 E-1-3\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.2.3\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nEPA QA\/G-5 2.1.8\r\n\nE.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nISO 15189:2012 5.1.9\r\n\nNIST 800-53, Rev. 5, AT-2\u2013AT-4\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e\r\n\nUSDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (e)\r\n\nWHO Technical Report Series, #986, Annex 2, 9.4\r\n\nWHO Technical Report Series, #986, Annex 2, 10\n\n\n8.5 The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\n\n\n\nABFT Accreditation Manual Sec. B\r\n\nASTM E1578-18 E-1-4\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\n\n\n8.6 The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\n\n\n\nASTM E1578-18 E-1-5\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nNIST 800-53, Rev. 5, AT-2 and AT-3\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.7 The system should be able to produce a training matrix of personnel.\n\n\n\n7 CFR Part 331.15\r\n\n9 CFR Part 121.10 \r\n\n9 CFR Part 121.15 \r\n\n21 CFR Part 11.10 (i)\r\n\n21 CFR Part 58.29\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 211.25\r\n\n21 CFR Part 225.10\r\n\n21 CFR Part 226.10\r\n\n21 CFR Part 226.40\r\n\n21 CFR Part 820.25\r\n\n29 CFR Part 1910.1030 (g-2)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n29 CFR Part 1910.1200 (h)\r\n\n29 CFR Part 1910.1450 (e)\r\n\n42 CFR Part 73.10\r\n\n42 CFR Part 73.15\r\n\n42 CFR Part 493.43 (c)\r\n\n42 CFR Part 493.1235\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nA2LA C223 5.2\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\nAAVLD Requirements for an AVMDL Appendix 1\r\n\nABFT Accreditation Manual Sec. B\r\n\nAIHA-LAP Policies 2022 (various parts)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASTM E1578-18 C-3-5\r\n\nASTM E1578-18 D-1-6\r\n\nASTM E1578-18 E-1-6\r\n\nBRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nE.U. Annex 11-2\r\n\nEPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 1\r\n\nEPA QA\/G-5 2.1.8\r\n\nISO 15189:2012 4.1.2.1\r\n\nISO 15189:2012 5.1.6\r\n\nISO 15189:2012 5.1.9\r\n\nISO\/IEC 17025:2017 6.2.2\r\n\nISO\/IEC 17025:2017 6.2.3\r\n\nISO\/IEC 17025:2017 6.2.5\r\n\nISO\/IEC 17025:2017 6.2.6\r\n\nOECD GLP Principles 1.1.2\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\n\n\n8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n\n\n\n9. Compliance management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17 \r\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1251 (d)\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nASTM E1578-18 C-4-7\r\n\nASTM E1578-18 E-2-1\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Annex 11-9\r\n\nE.U. Annex 11-14\r\n\nOECD GLP Principles 8.3.5\r\n\nUSDA Data and Instrumentation for PDP 8.1.3\n\n\n9.1 The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-2\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCJIS Security Policy Appendix G.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Annex 11-9\r\n\nE.U. Annex 11-12.4\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nNIST 800-53, Rev. 5, AC-2(4) and AC-6(9)\r\n\nNIST 800-53, Rev. 5, AU-2 and AU-3\r\n\nNIST 800-53, Rev. 5, CM-5(1)\r\n\nOECD GLP Principles 8.3.5\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n9.2 The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1274\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-3\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCLSI QMS22 2.2.3.2\r\n\nCLSI QMS22 2.4.3\r\n\nE.U. Annex 11-12.4\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nNIST 800-53, Rev. 5, AU-3 and AU-8\r\n\nOECD GLP Principles 8.3.5\r\n\nUSDA Data and Instrumentation for PDP 8.1.4\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.3 The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-4\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nICH GCP 4.9.0 and 4.9.3\r\n\nNIST 800-53, Rev. 5, AU-3\r\n\nOECD GLP Principles 8.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.4 The system's audit trail shall document the previous and current value of a modified field.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1251 (d)\r\n\n45 CFR Part 164.310\r\n\nASTM E1578-18 E-2-5\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nE.U. Annex 11-14\r\n\nOECD GLP Principles 8.3.5\n\n\n9.5 The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\n\n\n21 CFR Part 11.70\r\nE.U. Annex 11-14\n\n9.6 The system shall prevent a user from copying and pasting the electronic signature of another user.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 58.130 (e)\r\n\n42 CFR Part 493.1274 (d)\r\n\nE.U. Annex 11-9\r\n\nNIST 800-53, Rev. 5, AU-6 and AU-12\r\n\nOECD GLP Principles 8.3.5\n\n\n9.7 The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\n\n\n\n10. Instrument and equipment management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-3-1\n\n10.1 The system should provide a means for tracking usage of laboratory equipment and instruments.\n\n\nASTM E1578-18 E-3-2\n\n10.2 The system shall provide a means for planning the use of and reserving equipment and instruments.\n\n\nASTM E1578-18 E-3-3\n\n10.3 The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\n\n\nASTM E1578-18 E-3-4\n\n10.4 The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\n\n\nASTM E1578-18 E-3-5\n\n10.5 The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\n\n\nASTM E1578-18 E-3-6\n\n10.6 The system shall be able to group instruments together in specific ways, including by type and laboratory location.\n\n\n\n21 CFR Part 110.40 (f)\r\n\n21 CFR Part 211.67\u201368\r\n\n21 CFR Part 211.160 (b-4)\r\n\n21 CFR Part 212.30 (b)\r\n\n21 CFR Part 212.60 (e)\r\n\n21 CFR Part 225.30 (b-4)\r\n\n21 CFR Part 606.60\r\n\n21 CFR Part 820.70 (g)\r\n\n21 CFR Part 820.72\r\n\n42 CFR Part 493.1252 (b-3)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.5.2\r\n\nA2LA C223 5.5\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5\r\n\nABFT Accreditation Manual Sec. E-20\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1\r\n\nAIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\nASTM E1578-18 E-3-7\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.6.1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nISO 15189:2012 5.3.1.4\r\n\nISO\/IEC 17025:2017 6.4.7\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nISO\/TS 22002-4:2013, 4.7.1\r\n\nISO\/TS 22002-6:2016, 4.7\r\n\nNIST 800-53, Rev. 5, MA-2 and MA-2(2)\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Data and Instrumentation for PDP 5.2\r\n\nUSDA Data and Instrumentation for PDP 6\r\n\nWADA International Standard for Laboratories (ISL) 5.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 13.5\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\n\n\n\n21 CFR Part 225.30 (b-4)\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5.9\r\n\nASTM E1578-18 E-3-8\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.8 The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\n\n\n\n21 CFR Part 211.160 (b-4)\r\n\nA2LA C211 5.5.7\r\n\nA2LA C223 5.6\r\n\nABFT Accreditation Manual Sec. E-21\r\n\nASTM E1578-18 E-3-9\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nCLSI QMS22 2.1.2.1\r\n\nIFS Food 7, Part 2, 5.4.3\r\n\nIFS PACsecure 2, Part 2, 5.4.3\r\n\nISO 15189:2012 5.3.1.5\r\n\nISO\/IEC 17025:2017 6.4.9\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)\r\n\nWHO Technical Report Series, #986, Annex 2, 13.10\n\n\n10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.\n\n\n\n21 CFR Part 111.117\r\n\n21 CFR Part 820.72 (b-2)\r\n\nASTM E1578-18 E-3-10\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nNIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\n\n\n\n21 CFR Part 820.72 (b-1)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.6.2.1\r\n\nA2LA C223 5.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.6.1\u20132\r\n\nAIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nISO\/IEC 17025:2017 6.5\r\n\nISO\/TS 22002-4:2013, 4.7.1\r\n\nISO\/TS 22002-6:2016, 4.7\r\n\nOECD GLP Principles 4.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.2\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)\r\n\nUSDA Data and Instrumentation for PDP 6.1\n\n\n10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\n\n\nASTM E1578-18 E-3-11\n\n10.12 The system shall support the use of predefined intervals when calculating instrument event dates.\n\n\n\n21 CFR Part 110.40 (f)\r\n\n21 CFR Part 211.105 (b)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.5.4 and 5.5.5\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5.4\u20135\r\n\nASTM E1578-18 E-3-12\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1\r\n\nIFS Food 7, Part 2, 5.4.1\r\n\nIFS PACsecure 2, Part 2, 5.4.1\r\n\nISO 15189:2012 5.3.1.7\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nISO\/IEC 17025:2017 6.4.13\r\n\nNIST 800-53, Rev. 5, CM-8\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\nUSDA Administrative Procedures for the PDP 7.2\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4\r\n\nWHO Technical Report Series, #961, Annex 13, 6.1\n\n\n10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\n\n\nASTM E1578-18 E-3-13\n\n10.14 The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\n\n\n\n10 CFR Part 20.2103\r\n\n21 CFR Part 58.63\r\n\n21 CFR Part 111.117\r\n\n21 CFR Part 211.67\u201368\r\n\n21 CFR Part 211.160 (b-4)\r\n\n21 CFR Part 211.182\r\n\n21 CFR Part 211.194 (d)\r\n\n21 CFR Part 212.30 (b)\r\n\n21 CFR Part 212.60 (e)\r\n\n21 CFR Part 820.70 (g)\r\n\n21 CFR Part 820.72\r\n\n42 CFR Part 493.1254\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 4.13.2.1\r\n\nA2LA C211 5.5.2\r\n\nA2LA C211 5.10.4\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5\r\n\nABFT Accreditation Manual Sec. E-20 and -23\r\n\nABFT Accreditation Manual Sec. F-1 and I-1\r\n\nAIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\nASTM E1578-18 E-3-14\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.2.1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nISO 15189:2012 5.3.1.4\r\n\nISO\/IEC 17025:2017 6.4.4\r\n\nNIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 4.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Data and Instrumentation for PDP 5.4\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c\r\n\nWADA International Standard for Laboratories (ISL) 5.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 15.46\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.15 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\n\n\n\n11. Batch and lot management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 58.105 (a)\r\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nASTM E1578-18 E-4-1\r\n\nEPA ERLN Laboratory Requirements 3.3\r\n\nEPA ERLN Laboratory Requirements 4.10.1\r\n\nOECD GLP Principles 6.2\n\n\n11.1 The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\n\n\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nASTM E1578-18 E-4-2\r\n\nEPA ERLN Laboratory Requirements 4.10.1\n\n\n11.2 The system shall maintain the links between component parts of a batch and track the batch throughout the system.\n\n\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 820.65\r\n\nASTM E1578-18 E-4-3\n\n\n11.3 The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\n\n\nASTM E1578-18 E-4-4\n\n11.4 The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\n\n\nE.U. Annex 11-15\n\n11.5 The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\n\n\n\n12. Scheduled event management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 129.80 (g)\r\nASTM E1578-18 E-5-1\r\nUSDA Sampling Procedures for PDP 5.6\u20137\n\n12.1 The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.\n\n\n21 CFR Part 212.61 (a)\r\n21 CFR Part 211.166 (b)\r\nASTM E1578-18 E-5-2\n\n12.2 The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.\n\n\nASTM E1578-18 E-5-3\n\n12.3 The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\n\n\nASTM E1578-18 E-5-4\n\n12.4 The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).\n\n\nASTM E1578-18 E-5-5\n\n12.5 The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\n\n\n\n13. Instrument data capture and control \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-6-1\n\n13.1 The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\n\n\nASTM E1578-18 E-6-2\n\n13.2 The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\n\n\nASTM E1578-18 E-6-3\n\n13.3 The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\n\n\nASTM E1578-18 E-6-4\n\n13.4 The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\n\n\nASTM E1578-18 E-6-5\n\n13.5 The system should be able to accept the results uploaded from an interfaced instrument.\n\n\nASTM E1578-18 E-6-6\n\n13.6 The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\n\n\nASTM E1578-18 E-6-7\n\n13.7 The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\n\n\nASTM E1578-18 E-6-8\n\n13.8 The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\n\n\n\n14. Standard and reagent management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 58.83\r\n\n29 CFR Part 1910.1200 (g)\r\n\n29 CFR Part 1910.1450 (h)\r\n\n42 CFR Part 493.1252 (c)\r\n\nABFT Accreditation Manual Sec. E-17\r\n\nASTM E1578-18 E-7-1\r\n\nISO 15189:2012 5.3.2.4\u20135\r\n\nOECD GLP Principles 4.4\n\n\n14.1 The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\n\n\n\n7 CFR Part 331.3\r\n\n9 CFR Part 121.3\r\n\n21 CFR Part 312.58 (b)\r\n\n42 CFR Part 73.3\u20134 (c)\r\n\nASTM E1578-18 E-7-2\r\n\nEPA ERLN Laboratory Requirements 4.1.12\r\n\nISO 15189:2012 5.3.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 12.20\n\n\n14.2 The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\n\n\nASTM E1578-18 E-7-3\r\nISO 15189:2012 5.3.2.4\n\n14.3 The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\n\n\nASTM E1578-18 E-7-4\r\nISO 15189:2012 5.3.2.4\n\n14.4 The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\n\n\nASTM E1578-18 E-7-5\r\nISO 15189:2012 5.3.2.4\n\n14.5 The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\n\n\n\n15. Inventory management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-8-1\r\nCAP Laboratory Accreditation Manual\r\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples and specimens.\n\n\n\n21 CFR Part 212.60 (d)\r\n\nASTM E1578-18 E-8-2\r\n\nCLSI QMS22 2.1.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.2 The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\n\n\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.101\r\n\n21 CFR Part 212.60 (d)\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 606.120 (b)\r\n\n29 CFR Part 1910.1030 (g)\r\n\n29 CFR Part 1910.1096 (e-6)\r\n\n29 CFR Part 1910.1200 (f-6) and (f-10)\r\n\n40 CFR Part 262.206\r\n\nASTM E1578-18 E-8-3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOSHA 1910.1200(b)(3) and (f)\r\n\nOSHA 1910.1450(h)\r\n\nWHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41\r\n\nWHO Technical Report Series, #986, Annex 2, 15.10\u201312\n\n\n15.3 The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\n\n\n\n21 CFR Part 117.420\r\n\n21 CFR Part 212.40 (c)\r\n\n21 CFR Part 820.50\r\n\nA2LA C211 4.6\r\n\nASTM E1578-18 E-8-4\r\n\nBRC GSFS, Issue 8, 3.5.1.4\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5\r\n\nIFS Food 7, Part 2, 4.4.1\r\n\nIFS PACsecure 2, Part 2, 4.4.1\r\n\nISO\/TS 22002-1:2009, 9.2\r\n\nISO\/TS 22002-4:2013, 4.6.2\r\n\nISO\/TS 22002-6:2016, 4.6.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.4.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)\r\n\nUSDA Administrative Procedures for the PDP 7.1\r\n\nWHO Technical Report Series, #961, Annex 13, 7.1 and 7.3\r\n\nWHO Technical Report Series, #986, Annex 2, 14.8\n\n\n15.4 The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\n\n\n\n21 CFR Part 211.196\r\n\n21 CFR Part 212.90\r\n\n21 CFR Part 225.110\r\n\n21 CFR Part 606.165\r\n\n29 CFR Part 1910.1450 Appendix A (I)\r\n\nA2LA C211 4.6\r\n\nASTM E1578-18 E-8-5\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5\n\n\n15.5 The system should provide a means for accurately recording the receipt, approval, distribution, and disposal of materials.\n\n\n\n21 CFR Part 211.82 (b)\r\n\n21 CFR Part 211.84 (a)\r\n\n21 CFR Part 211.89\r\n\n21 CFR Part 211.110 (d)\r\n\n21 CFR Part 211.142 (a)\r\n\n21 CFR Part 212.40 (c)\r\n\nASTM E1578-18 E-8-6\r\n\nWHO Technical Report Series, #986, Annex 2, 12.18\n\n\n15.6 The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\n\n\n\n21 CFR Part 211.89\r\n\n21 CFR Part 211.110 (d)\r\n\n42 CFR Part 493.1252 (d)\r\n\nASTM E1578-18 E-8-7\n\n\n15.7 The system should allow authorized personnel to retire faulty or poor quality materials from use.\n\n\n\n21 CFR Part 211.89\r\nASTM E1578-18 E-8-8\n\n\n15.8 The system shall clearly designate a standard or reagent as being disposed or consumed.\n\n\n\n16. Investigation and quality management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 312.62 (b)\r\n21 CFR Part 812.140 (a-3)\n\n16.1 The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\n\n\n\n21 CFR Part 312.57 (a)\r\n\n21 CFR Part 312.62 (a)\r\n\n21 CFR Part 606.165\r\n\n21 CFR Part 812.140 (a-2) and (b-2)\n\n\n16.2 The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\n\n\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 58.81 (a)\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.111\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 211.194\r\n\n21 CFR Part 606.171\r\n\n42 CFR Part 493.1253 (b-2)\r\n\nA2LA C211 5.4\r\n\nABFT Accreditation Manual C-16\r\n\nABFT Accreditation Manual F-2\r\n\nABFT Accreditation Manual J-3\r\n\nASTM E1578-18 E-9-1\r\n\nBRC GSFS, Issue 8, 5.6.2.3\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nCLSI QMS22 2.2.2.2\r\n\nEPA ERLN Laboratory Requirements 3.3\r\n\nEPA QA\/G-5 2.2.4\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\nISO\/IEC 17025:2017 7.2.1.7\r\n\nISO\/IEC 17025:2017 7.2.2.1\r\n\nISO\/IEC 17025:2017 7.10.2\r\n\nISO\/IEC 17025:2017 8.7.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 7.3\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)\r\n\nUSDA Administrative Procedures for the PDP 8.2.2\r\n\nWADA International Standard for Laboratories (ISL) 5.3.6\r\n\nWHO Technical Report Series, #986, Annex 2, 16.3\n\n\n16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\n\n\n42 CFR Part 493.1282\r\nASTM E1578-18 E-9-2\r\nE.U. Commission Reg. No. 2073\/2005 Article 9\n\n16.4 The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\n\n\n\n21 CFR Part 606.100 (c)\r\n\n42 CFR Part 493.1282\r\n\nASTM E1578-18 E-9-3\r\n\nCLSI QMS22 2.1.2.1\r\n\nCLSI QMS22 2.2.2.3\r\n\nEPA QA\/G-5 2.2.10\r\n\nWHO Technical Report Series, #986, Annex 2, 17.12\r\n\nWHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.5 The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\n\n\n\n10 CFR Part 30.34 (g)\r\n\n21 CFR Part 112.147\r\n\n21 CFR Part 225.58 (d)\r\n\n21 CFR Part 225.158\r\n\n21 CFR Part 606.100 (c)\r\n\n21 CFR Part 820.100\r\n\n42 CFR Part 493.1282\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nA2LA C211 4.9 and 4.11\r\n\nASTM E1578-18 E-9-4\r\n\nBRC GSFS, Issue 8, 3.4.3\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCLSI QMS22 2.6.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nFDA Hazard Analysis Critical Control Point Principle 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5, IR-5\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\nWADA International Standard for Laboratories (ISL) 5.3.9\r\n\nWHO Technical Report Series, #961, Annex 13, 11.1\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\r\n\nWHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\n\n\n\n21 CFR Part 225.58 (d)\r\n\n21 CFR Part 225.158\r\n\n42 CFR Part 493.1282\r\n\n42 CFR Part 493.1289\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nA2LA C211 4.8 and 4.11\r\n\nASTM E1578-18 E-9-5\r\n\nBRC GSFS, Issue 8, 3.4.3\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.3.4\r\n\nCJIS Security Policy Appendix G.7\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nFDA Hazard Analysis Critical Control Point Principle 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5, AU-6(1)\r\n\nNIST 800-53, Rev. 5, IR-4(1) and IR-5\r\n\nNIST 800-53, Rev. 5, SI-2 and SI-4\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\n\n\n16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\n\n\nASTM E1578-18 E-9-6\n\n16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\n\n\n9 CFR Part 2.35\n\n16.9 The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#10._Instrument_and_equipment_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#10._Instrument_and_equipment_management<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 2 May 2022, at 22:08.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2,552 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","bff44fcebcd26459117e31bbd8c99ea1_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Maintaining_Laboratory_Workflow_and_Operations rootpage-LII_LIMSpec_Maintaining_Laboratory_Workflow_and_Operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Maintaining Laboratory Workflow and Operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"7._Document_and_records_management\">7. Document and records management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/part-20\" target=\"_blank\">10 CFR Part 20 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.213\u201314<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(e) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.1<\/b> The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.214<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.300\" target=\"_blank\">42 CFR Part 93.300\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1773\" target=\"_blank\">42 CFR Part 493.1773 (c\u2013d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/160.310\" target=\"_blank\">45 CFR Part 160.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 Appendix H5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.2<\/b> The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.3<\/b> The system shall be able to clearly provide the most current version of a document and archive prior versions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.4<\/b> The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.91 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.14<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.5<\/b> The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-12, -14, and -15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.13<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.6<\/b> The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.10\" target=\"_blank\">7 CFR Part 331.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (j-3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.210\" target=\"_blank\">40 CFR Part 262.210\u201312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.7<\/b> The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.8<\/b> The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.9<\/b> The system shall support the addition of accurate cross-references and page numbers to new documents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.10<\/b> The system shall be capable of uniquely identifying documents created in and added to the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>7.11<\/b> The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"8._Resource_management\">8. Resource management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (m)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-3 and -4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.1<\/b> The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.198\" target=\"_blank\">21 CFR Part 820.198<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1233\" target=\"_blank\">42 CFR Part 493.1233<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.10.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.2<\/b> The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123<\/a> 21 CFR Part 123.10]<br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.3<\/b> The system shall allow training sessions and reviews to be scheduled for personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.4<\/b> The system should provide access to relevant training materials to personnel attending training sessions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2\u2013AT-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.5<\/b> The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.6<\/b> The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.7<\/b> The system should be able to produce a training matrix of personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (various parts)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.8<\/b> The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"9._Compliance_management\">9. Compliance management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.1<\/b> The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-2 and AU-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.2<\/b> The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3 and AU-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.3<\/b> The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.4<\/b> The system's audit trail shall document the previous and current value of a modified field.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.5<\/b> The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>9.6<\/b> The system shall prevent a user from copying and pasting the electronic signature of another user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6 and AU-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.7<\/b> The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"10._Instrument_and_equipment_management\">10. Instrument and equipment management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.1<\/b> The system should provide a means for tracking usage of laboratory equipment and instruments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.2<\/b> The system shall provide a means for planning the use of and reserving equipment and instruments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.3<\/b> The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.4<\/b> The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.5<\/b> The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.6<\/b> The system shall be able to group instruments together in specific ways, including by type and laboratory location.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.60\" target=\"_blank\">21 CFR Part 606.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (b-3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2 and MA-2(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.7<\/b> The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.8<\/b> The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.9<\/b> The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.10<\/b> The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.6.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.11<\/b> The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.12<\/b> The system shall support the use of predefined intervals when calculating instrument event dates.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.4 and 5.5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.13<\/b> The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-13<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.14<\/b> The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.63\" target=\"_blank\">21 CFR Part 58.63<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.182\" target=\"_blank\">21 CFR Part 211.182<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1254\" target=\"_blank\">42 CFR Part 493.1254<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20 and -23<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. F-1 and I-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.46<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.15<\/b> The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"11._Batch_and_lot_management\">11. Batch and lot management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.1<\/b> The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.2<\/b> The system shall maintain the links between component parts of a batch and track the batch throughout the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.65\" target=\"_blank\">21 CFR Part 820.65<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.3<\/b> The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>11.4<\/b> The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-15<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>11.5<\/b> The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"12._Scheduled_event_management\">12. Scheduled event management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.6\u20137<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.1<\/b> The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.2<\/b> The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.3<\/b> The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.4<\/b> The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.5<\/b> The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"13._Instrument_data_capture_and_control\">13. Instrument data capture and control<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.1<\/b> The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.2<\/b> The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.3<\/b> The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.4<\/b> The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.5<\/b> The system should be able to accept the results uploaded from an interfaced instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.6<\/b> The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.7<\/b> The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.8<\/b> The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"14._Standard_and_reagent_management\">14. Standard and reagent management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.83\" target=\"_blank\">21 CFR Part 58.83<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>14.1<\/b> The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.3\" target=\"_blank\">7 CFR Part 331.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.3\" target=\"_blank\">9 CFR Part 121.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.3\" target=\"_blank\">42 CFR Part 73.3\u20134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.20<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>14.2<\/b> The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.3<\/b> The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.4<\/b> The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.5<\/b> The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"15._Inventory_management\">15. Inventory management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>15.1<\/b> The system should be capable of accurately tracking the specific quantities of received and consumed test samples and specimens.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.2<\/b> The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (f-6) and (f-10)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.206\" target=\"_blank\">40 CFR Part 262.206<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.10\u201312<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.3<\/b> The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.50\" target=\"_blank\">21 CFR Part 820.50<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.4<\/b> The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.196\" target=\"_blank\">21 CFR Part 211.196<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.90\" target=\"_blank\">21 CFR Part 212.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 Appendix A (I)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.5<\/b> The system should provide a means for accurately recording the receipt, approval, distribution, and disposal of materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.82\" target=\"_blank\">21 CFR Part 211.82 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.142\" target=\"_blank\">21 CFR Part 211.142 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.6<\/b> The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.7<\/b> The system should allow authorized personnel to retire faulty or poor quality materials from use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.8<\/b> The system shall clearly designate a standard or reagent as being disposed or consumed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"16._Investigation_and_quality_management\">16. Investigation and quality management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.1<\/b> The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-2) and (b-2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.2<\/b> The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.81\" target=\"_blank\">21 CFR Part 58.81 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.171\" target=\"_blank\">21 CFR Part 606.171<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1253\" target=\"_blank\">42 CFR Part 493.1253 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual F-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual J-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.3<\/b> The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.4<\/b> The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.5<\/b> The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.147<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.100\" target=\"_blank\">21 CFR Part 820.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.9 and 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 11.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.6<\/b> The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1289\" target=\"_blank\">42 CFR Part 493.1289<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.8 and 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-4(1) and IR-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2 and SI-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.7<\/b> The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.8<\/b> The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.9<\/b> The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173541\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.104 seconds\nReal time usage: 0.111 seconds\nPreprocessor visited node count: 1035\/1000000\nPost\u2010expand include size: 141529\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 20.237 1 -total\n 11.99% 2.426 1 Template:LIMSpec\/Document_management\n 10.55% 2.135 1 Template:LIMSpec\/Resource_management\n 9.87% 1.998 1 Template:LIMSpec\/Instrument_and_equipment_management\n 9.68% 1.958 1 Template:LIMSpec\/Compliance_management\n 9.13% 1.848 1 Template:LIMSpec\/Batch_and_lot_management\n 9.07% 1.836 1 Template:LIMSpec\/Investigation_and_quality_management\n 8.97% 1.815 1 Template:LIMSpec\/Inventory_management\n 8.81% 1.782 1 Template:LIMSpec\/Scheduled_event_management\n 8.72% 1.764 1 Template:LIMSpec\/Instrument_data_capture_and_control\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11181-0!canonical and timestamp 20221202173541 and revision id 47569. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#10._Instrument_and_equipment_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#10._Instrument_and_equipment_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","bff44fcebcd26459117e31bbd8c99ea1_images":[],"bff44fcebcd26459117e31bbd8c99ea1_timestamp":1670002542,"c4fcb640c65b0c1a19ddb8ac2a708071_type":"article","c4fcb640c65b0c1a19ddb8ac2a708071_title":"9. Compliance management","c4fcb640c65b0c1a19ddb8ac2a708071_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#9._Compliance_management","c4fcb640c65b0c1a19ddb8ac2a708071_plaintext":"\n\nLII:LIMSpec\/Maintaining Laboratory Workflow and OperationsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.\n\n7. Document and records management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n7 CFR Part 331 (throughout)\r\n\n9 CFR Part 121 (throughout)\r\n\n10 CFR Part 20 (throughout)\r\n\n21 CFR Part 7 (throughout)\r\n\n21 CFR Part 117 (throughout)\r\n\n21 CFR Part 58 (throughout)\r\n\n21 CFR Part 211 (throughout)\r\n\n21 CFR Part 212 (throughout)\r\n\n21 CFR Part 225 (throughout)\r\n\n21 CFR Part 226 (throughout)\r\n\n21 CFR Part 312 (throughout)\r\n\n21 CFR Part 606 (throughout)\r\n\n21 CFR Part 810 (throughout)\r\n\n21 CFR Part 812 (throughout)\r\n\n21 CFR Part 820 (throughout)\r\n\n29 CFR Part 1910.134 (throughout)\r\n\n29 CFR Part 1910.1030 (throughout)\r\n\n29 CFR Part 1910.1200 (throughout)\r\n\n29 CFR Part 1910.1450 (throughout)\r\n\n40 CFR Part 262.213\u201314\r\n\n42 CFR Part 73 (throughout)\r\n\n42 CFR Part 493.1200\r\n\n42 CFR Part 493.1232\r\n\n42 CFR Part 493.1239\r\n\n42 CFR Part 493.1251\r\n\n42 CFR Part 493.1291 (j)\r\n\n45 CFR Part 164 (throughout)\r\n\n61 FR 38806 (throughout)\r\n\nA2LA C211 4.3\r\n\nA2LA C223 4.13\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\nAAVLD Requirements for an AVMDL (throughout)\r\n\nABFT Accreditation Manual (throughout)\r\n\nASTM E1188-11 3.5.2\r\n\nASTM E1492-11 4.3.3.3 and 4.4.4\r\n\nASTM E1578-18 D-1-1\r\n\nBRC GSFS, Issue 8, 3.1.1\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nBRC GSFS, Issue 8, 5.6.1.1\r\n\nBRC GSFS, Issue 8, 5.6.2.2\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual (throughout)\r\n\nCJIS Security Policy (throughout)\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)\r\n\nEPA 815-R-05-004 (throughout)\r\n\nEPA ERLN Laboratory Requirements (throughout)\r\n\nEPA QA\/G-5 (throughout)\r\n\nE.U. Commission Directive 2003\/94\/EC (throughout)\r\n\nFDA Hazard Analysis Critical Control Point (throughout)\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\nIFS Food 7, Part 2 (throughout)\r\n\nIFS PACsecure 2, Part 2 (throughout)\r\n\nISO 15189:2012 4.3\r\n\nISO 15189:2012 5.5.3\r\n\nISO 15189:2012 5.9.3\r\n\nISO\/IEC 17025:2017 5.3\r\n\nISO\/IEC 17025:2017 5.5\r\n\nISO\/IEC 17025:2017 8.3.2\r\n\nISO\/TS 22002-1:2009 (throughout)\r\n\nISO\/TS 22002-4:2013 (throughout)\r\n\nISO\/TS 22002-6:2016 (throughout)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5 (throughout)\r\n\nOECD GLP Principles 8\r\n\nOSHA 1910.1200(b)(3)\r\n\nOSHA 1910.1450(e) and (h)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\nSQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nUSDA Data and Instrumentation for PDP (throughout)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\nWHO Technical Report Series, #961, Annex 13 (throughout)\r\n\nWHO Technical Report Series, #986, Annex 2 (throughout)\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\n\n\n\n7 CFR Part 331 (throughout)\r\n\n9 CFR Part 121 (throughout)\r\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 7 (throughout)\r\n\n21 CFR Part 58 (throughout)\r\n\n21 CFR Part 117 (throughout)\r\n\n21 CFR Part 211 (throughout)\r\n\n21 CFR Part 212 (throughout)\r\n\n21 CFR Part 225 (throughout)\r\n\n21 CFR Part 226 (throughout)\r\n\n21 CFR Part 312 (throughout)\r\n\n21 CFR Part 606 (throughout)\r\n\n21 CFR Part 810 (throughout)\r\n\n21 CFR Part 812 (throughout)\r\n\n21 CFR Part 820 (throughout)\r\n\n29 CFR Part 1910.134 (c)\r\n\n29 CFR Part 1910.1030 (throughout)\r\n\n29 CFR Part 1910.1200 (e)\r\n\n29 CFR Part 1910.1450 (throughout)\r\n\n40 CFR Part 262.214\r\n\n42 CFR Part 73 (throughout)\r\n\n42 CFR Part 93.300\u20135\r\n\n42 CFR Part 493.1200\r\n\n42 CFR Part 493.1232\r\n\n42 CFR Part 493.1239\r\n\n42 CFR Part 493.1251\r\n\n42 CFR Part 493.1291 (j)\r\n\n42 CFR Part 493.1773 (c\u2013d)\r\n\n45 CFR Part 160.310\r\n\n45 CFR Part 164 (throughout)\r\n\n61 FR 38806 (throughout)\r\n\nA2LA C211 (throughout)\r\n\nA2LA C223 (throughout)\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\nAAVLD Requirements for an AVMDL (throughout)\r\n\nACMG Technical Standards for Clinical Genetics Laboratories (throughout)\r\n\nAIHA-LAP Policies 2022 Appendix H5.8\r\n\nASTM E1188-11 3.5.2\r\n\nASTM E1492-11 4.3.3.3 and 4.4.4\r\n\nASTM E1578-18 D-1-2\r\n\nBRC GSFS, Issue 8, 3.1.2\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nBRC GSFS, Issue 8, 5.6.2.2\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual (throughout)\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)\r\n\nCJIS Security Policy (throughout)\r\n\nCLSI QMS22 (throughout)\r\n\nEPA 815-R-05-004 (throughout)\r\n\nEPA ERLN Laboratory Requirements (throughout)\r\n\nEPA QA\/G-5 (throughout)\r\n\nE.U. Commission Directive 2003\/94\/EC (throughout)\r\n\nFDA Hazard Analysis Critical Control Point (throughout)\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\nIFS Food 7, Part 2 (throughout)\r\n\nIFS PACsecure 2, Part 2 (throughout)\r\n\nISO 15189:2012 (throughout)\r\n\nISO\/IEC 17025:2017 (throughout)\r\n\nISO\/TS 22002-1:2009 (throughout)\r\n\nISO\/TS 22002-4:2013 (throughout)\r\n\nISO\/TS 22002-6:2016 (throughout)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5 (throughout)\r\n\nOECD GLP Principles 8\r\n\nOSHA 1910.1020 (throughout)\r\n\nOSHA 1910.1200(b)(3)\r\n\nOSHA 1910.1450(h)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\nSQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nUSDA Data and Instrumentation for PDP (throughout)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines (throughout)\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3\r\n\nUSDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\nWADA International Standard for Laboratories (ISL) (throughout)\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\r\n\nWHO Technical Report Series, #961, Annex 13 (throughout)\r\n\nWHO Technical Report Series, #986, Annex 2 (throughout)\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.2 The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\n\n\n\n21 CFR Part 1.1154 (c)\r\n\n21 CFR Part 820.40 (a)\r\n\n42 CFR Part 493.1251 (e)\r\n\nA2LA C211 4.3\r\n\nAAVLD Requirements for an AVMDL Sec. 4.3\r\n\nASTM E1578-18 D-1-3\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nEPA 815-R-05-004 Chap. III, Sec. 11\r\n\nEPA ERLN Laboratory Requirements 4.2.4.2\r\n\nEPA QA\/G-5 2.1.9\r\n\nISO 15189:2012 4.3\r\n\nISO 15189:2012 5.5.3\r\n\nISO 15189:2012 5.9.3\r\n\nISO\/IEC 17025:2017 7.5.2\r\n\nISO\/IEC 17025:2017 8.3.2\r\n\nUSDA Administrative Procedures for the PDP 5.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.5\n\n\n7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.\n\n\nASTM E1578-18 D-1-4\n\n7.4 The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1151\r\n\n21 CFR Part 1.1152 (e)\r\n\n21 CFR Part 106.91 (c)\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.315\r\n\n21 CFR Part 111.320\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.160\r\n\n21 CFR Part 212.20 (c)\r\n\n21 CFR Part 212.60 (c)\r\n\n21 CFR Part 226.58 (e)\r\n\n21 CFR Part 820.250 (b)\r\n\n42 CFR Part 493.43 (c)\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nASTM E1578-18 D-1-5\r\n\nBRC GSFS, Issue 8, 5.6.1.1\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.3\r\n\nCodex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\nCodex Alimentarius CXS 234-1999 (throughout)\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 5\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\nIFS Food 7, Part 2, 5.5.2\r\n\nIFS Food 7, Part 2, 5.6.2\r\n\nIFS PACsecure 2, Part 2, 5.5.2\r\n\nIFS PACsecure 2, Part 2, 5.6.2\r\n\nISO\/IEC 17025:2017 6.5\r\n\nISO\/IEC 17025:2017 7.2.1.3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)\r\n\nUSDA Administrative Procedures for the PDP 8.4\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1\r\n\nWHO Technical Report Series, #986, Annex 2, 15.14\n\n\n7.5 The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1151\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.320\r\n\n21 CFR Part 212.20 (c)\r\n\n21 CFR Part 212.70 (b)\r\n\nA2LA C211 5.4.5\r\n\nA2LA C223 5.4\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.4\r\n\nABFT Accreditation Manual Sec. G-12, -14, and -15\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C10\r\n\nACMG Technical Standards for Clinical Genetics Laboratories F7.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4\r\n\nCodex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\nCodex Alimentarius CXS 234-1999 (throughout)\r\n\nEPA QA\/G-5 2.2.4\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\nISO\/IEC 17025:2017 7.2.2.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\nUSDA Administrative Procedures for the PDP 8.4\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6\r\n\nWHO Technical Report Series, #961, Annex 13, 10.1\r\n\nWHO Technical Report Series, #986, Annex 2, 4.11\r\n\nWHO Technical Report Series, #986, Annex 2, 15.13\n\n\n7.6 The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\n\n\n\n7 CFR Part 331.10\r\n\n7 CFR Part 331.15\r\n\n9 CFR Part 2.32\r\n\n9 CFR Part 121.10 \r\n\n9 CFR Part 121.15 \r\n\n10 CFR Part 30.34 (j-3)\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 11.10 (i)\r\n\n21 CFR Part 58.29\r\n\n21 CFR Part 211.25\r\n\n21 CFR Part 225.10\r\n\n21 CFR Part 226.10\r\n\n21 CFR Part 226.40\r\n\n21 CFR Part 820.25\r\n\n29 CFR Part 1910.134 (c)\r\n\n29 CFR Part 1910.1030 (g-2)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n29 CFR Part 1910.1200 (h)\r\n\n29 CFR Part 1910.1450 (f)\r\n\n40 CFR Part 262.207\r\n\n40 CFR Part 262.210\u201312\r\n\n42 CFR Part 73.10\r\n\n42 CFR Part 73.15\r\n\n42 CFR Part 493.43 (c)\r\n\n42 CFR Part 493.1235\r\n\n42 CFR Part 493.1251\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 417.5\r\n\nA2LA C211 5.2\r\n\nA2LA C223 5.2\r\n\nA2LA C223 5.7\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\nAAVLD Requirements for an AVMDL Appendix 1\r\n\nABFT Accreditation Manual Sec. B\r\n\nACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.4\r\n\nAIHA-LAP Policies 2022 (throughout)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASTM E1578-18 C-3-5\r\n\nASTM E1578-18 D-1-6\r\n\nASTM E1578-18 E-1-6\r\n\nBRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nCAP Laboratory Accreditation Manual\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCLSI QMS22 (throughout)\r\n\nE.U. Annex 11-2\r\n\nE.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\nEPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 1\r\n\nEPA QA\/G-5 2.1.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.1\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.1\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nISO 15189:2012 4.1.2.1\r\n\nISO 15189:2012 5.1.6\r\n\nISO 15189:2012 5.1.9\r\n\nISO\/IEC 17025:2017 6.2.2\r\n\nISO\/IEC 17025:2017 6.2.3\r\n\nISO\/IEC 17025:2017 6.2.5\r\n\nISO\/IEC 17025:2017 6.2.6\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nOECD GLP Principles 1.1.2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\n\n\n7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n\n\nASTM E1578-18 D-1-7\n\n7.8 The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\n\n\nAAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5\r\nEPA ERLN Laboratory Requirements 4.10.6\n\n7.9 The system shall support the addition of accurate cross-references and page numbers to new documents.\n\n\nAAVLD Requirements for an AVMDL Sec. 4.3.4\n\n7.10 The system shall be capable of uniquely identifying documents created in and added to the system.\n\n\nAPHL 2019 LIS Project Management Guidebook\r\n\n\n7.11 The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\n\n\n\n8. Resource management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n9 CFR Part 2.32\r\n\n10 CFR Part 20.2103\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 110.10 (c)\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.10\r\n\n29 CFR Part 1910.120\r\n\n29 CFR Part 1910.134 (m)\r\n\n29 CFR Part 1910.1030 (h-1)\r\n\n29 CFR Part 1910.1450 (j)\r\n\n40 CFR Part 262.207\r\n\nA2LA C211 4.13.2.3\r\n\nA2LA C223 5.2\r\n\nA2LA C223 5.7\r\n\nACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nBRC GSFS, Issue 8, 7.3.1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.2.3\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nEPA QA\/G-5 2.1.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.1\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.1\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nNIST 800-53, Rev. 5, AT-3 and -4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOSHA 1910.1020 (throughout)\r\n\nOSHA 1910.1200(b)(3) and (h)\r\n\nOSHA 1910.1450 (throughout)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nUSDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\r\n\nWHO Technical Report Series, #996, Annex 5, 8.1\n\n\n8.1 The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\n\n\n\n21 CFR Part 820.198\r\n\n42 CFR Part 493.1233\r\n\nBRC GSFS, Issue 8, 3.10.1\u20132\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21\r\n\nIFS Food 7, Part 2, 5.8\r\n\nIFS PACsecure 2, Part 2, 5.8\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)\r\n\nWADA International Standard for Laboratories (ISL) 5.3.10\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\n\n\n8.2 The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.\n\n\n\n5 CFR Part 930.301\r\n\n7 CFR Part 331.15\r\n\n9 CFR Part 121.15\r\n\n21 CFR Part 120.12\r\n\nhttps:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123 21 CFR Part 123.10]\r\n\n21 CFR Part 211.25\r\n\n29 CFR Part 1910.1450 (f)\r\n\n42 CFR Part 73.15\r\n\nA2LA C223 5.2\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3\r\n\nASTM E1578-18 E-1-1\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nCJIS Security Policy 5.2.1\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nNIST 800-53, Rev. 5, AT-2 and AT-3\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Sampling Procedures for PDP 6.1.2\u20133\r\n\nWHO Technical Report Series, #986, Annex 2, 10\n\n\n8.3 The system shall allow training sessions and reviews to be scheduled for personnel.\n\n\n\n5 CFR Part 930.301\r\n\n29 CFR Part 1910.1450 (f)\r\n\nABFT Accreditation Manual Sec. B\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7\r\n\nASTM E1578-18 E-1-2\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.4 The system should provide access to relevant training materials to personnel attending training sessions.\n\n\n\n5 CFR Part 930.301\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 110.10 (c)\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.10\r\n\n29 CFR Part 1910.1450 (f)\r\n\n40 CFR Part 262.207\r\n\nA2LA C223 5.2\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5\r\n\nASTM E1578-18 E-1-3\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.2.3\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nEPA QA\/G-5 2.1.8\r\n\nE.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nISO 15189:2012 5.1.9\r\n\nNIST 800-53, Rev. 5, AT-2\u2013AT-4\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e\r\n\nUSDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (e)\r\n\nWHO Technical Report Series, #986, Annex 2, 9.4\r\n\nWHO Technical Report Series, #986, Annex 2, 10\n\n\n8.5 The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\n\n\n\nABFT Accreditation Manual Sec. B\r\n\nASTM E1578-18 E-1-4\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\n\n\n8.6 The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\n\n\n\nASTM E1578-18 E-1-5\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nNIST 800-53, Rev. 5, AT-2 and AT-3\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.7 The system should be able to produce a training matrix of personnel.\n\n\n\n7 CFR Part 331.15\r\n\n9 CFR Part 121.10 \r\n\n9 CFR Part 121.15 \r\n\n21 CFR Part 11.10 (i)\r\n\n21 CFR Part 58.29\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 211.25\r\n\n21 CFR Part 225.10\r\n\n21 CFR Part 226.10\r\n\n21 CFR Part 226.40\r\n\n21 CFR Part 820.25\r\n\n29 CFR Part 1910.1030 (g-2)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n29 CFR Part 1910.1200 (h)\r\n\n29 CFR Part 1910.1450 (e)\r\n\n42 CFR Part 73.10\r\n\n42 CFR Part 73.15\r\n\n42 CFR Part 493.43 (c)\r\n\n42 CFR Part 493.1235\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nA2LA C223 5.2\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\nAAVLD Requirements for an AVMDL Appendix 1\r\n\nABFT Accreditation Manual Sec. B\r\n\nAIHA-LAP Policies 2022 (various parts)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASTM E1578-18 C-3-5\r\n\nASTM E1578-18 D-1-6\r\n\nASTM E1578-18 E-1-6\r\n\nBRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nE.U. Annex 11-2\r\n\nEPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 1\r\n\nEPA QA\/G-5 2.1.8\r\n\nISO 15189:2012 4.1.2.1\r\n\nISO 15189:2012 5.1.6\r\n\nISO 15189:2012 5.1.9\r\n\nISO\/IEC 17025:2017 6.2.2\r\n\nISO\/IEC 17025:2017 6.2.3\r\n\nISO\/IEC 17025:2017 6.2.5\r\n\nISO\/IEC 17025:2017 6.2.6\r\n\nOECD GLP Principles 1.1.2\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\n\n\n8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n\n\n\n9. Compliance management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17 \r\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1251 (d)\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nASTM E1578-18 C-4-7\r\n\nASTM E1578-18 E-2-1\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Annex 11-9\r\n\nE.U. Annex 11-14\r\n\nOECD GLP Principles 8.3.5\r\n\nUSDA Data and Instrumentation for PDP 8.1.3\n\n\n9.1 The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-2\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCJIS Security Policy Appendix G.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Annex 11-9\r\n\nE.U. Annex 11-12.4\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nNIST 800-53, Rev. 5, AC-2(4) and AC-6(9)\r\n\nNIST 800-53, Rev. 5, AU-2 and AU-3\r\n\nNIST 800-53, Rev. 5, CM-5(1)\r\n\nOECD GLP Principles 8.3.5\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n9.2 The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1274\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-3\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCLSI QMS22 2.2.3.2\r\n\nCLSI QMS22 2.4.3\r\n\nE.U. Annex 11-12.4\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nNIST 800-53, Rev. 5, AU-3 and AU-8\r\n\nOECD GLP Principles 8.3.5\r\n\nUSDA Data and Instrumentation for PDP 8.1.4\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.3 The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-4\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nICH GCP 4.9.0 and 4.9.3\r\n\nNIST 800-53, Rev. 5, AU-3\r\n\nOECD GLP Principles 8.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.4 The system's audit trail shall document the previous and current value of a modified field.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1251 (d)\r\n\n45 CFR Part 164.310\r\n\nASTM E1578-18 E-2-5\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nE.U. Annex 11-14\r\n\nOECD GLP Principles 8.3.5\n\n\n9.5 The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\n\n\n21 CFR Part 11.70\r\nE.U. Annex 11-14\n\n9.6 The system shall prevent a user from copying and pasting the electronic signature of another user.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 58.130 (e)\r\n\n42 CFR Part 493.1274 (d)\r\n\nE.U. Annex 11-9\r\n\nNIST 800-53, Rev. 5, AU-6 and AU-12\r\n\nOECD GLP Principles 8.3.5\n\n\n9.7 The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\n\n\n\n10. Instrument and equipment management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-3-1\n\n10.1 The system should provide a means for tracking usage of laboratory equipment and instruments.\n\n\nASTM E1578-18 E-3-2\n\n10.2 The system shall provide a means for planning the use of and reserving equipment and instruments.\n\n\nASTM E1578-18 E-3-3\n\n10.3 The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\n\n\nASTM E1578-18 E-3-4\n\n10.4 The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\n\n\nASTM E1578-18 E-3-5\n\n10.5 The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\n\n\nASTM E1578-18 E-3-6\n\n10.6 The system shall be able to group instruments together in specific ways, including by type and laboratory location.\n\n\n\n21 CFR Part 110.40 (f)\r\n\n21 CFR Part 211.67\u201368\r\n\n21 CFR Part 211.160 (b-4)\r\n\n21 CFR Part 212.30 (b)\r\n\n21 CFR Part 212.60 (e)\r\n\n21 CFR Part 225.30 (b-4)\r\n\n21 CFR Part 606.60\r\n\n21 CFR Part 820.70 (g)\r\n\n21 CFR Part 820.72\r\n\n42 CFR Part 493.1252 (b-3)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.5.2\r\n\nA2LA C223 5.5\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5\r\n\nABFT Accreditation Manual Sec. E-20\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1\r\n\nAIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\nASTM E1578-18 E-3-7\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.6.1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nISO 15189:2012 5.3.1.4\r\n\nISO\/IEC 17025:2017 6.4.7\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nISO\/TS 22002-4:2013, 4.7.1\r\n\nISO\/TS 22002-6:2016, 4.7\r\n\nNIST 800-53, Rev. 5, MA-2 and MA-2(2)\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Data and Instrumentation for PDP 5.2\r\n\nUSDA Data and Instrumentation for PDP 6\r\n\nWADA International Standard for Laboratories (ISL) 5.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 13.5\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\n\n\n\n21 CFR Part 225.30 (b-4)\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5.9\r\n\nASTM E1578-18 E-3-8\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.8 The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\n\n\n\n21 CFR Part 211.160 (b-4)\r\n\nA2LA C211 5.5.7\r\n\nA2LA C223 5.6\r\n\nABFT Accreditation Manual Sec. E-21\r\n\nASTM E1578-18 E-3-9\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nCLSI QMS22 2.1.2.1\r\n\nIFS Food 7, Part 2, 5.4.3\r\n\nIFS PACsecure 2, Part 2, 5.4.3\r\n\nISO 15189:2012 5.3.1.5\r\n\nISO\/IEC 17025:2017 6.4.9\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)\r\n\nWHO Technical Report Series, #986, Annex 2, 13.10\n\n\n10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.\n\n\n\n21 CFR Part 111.117\r\n\n21 CFR Part 820.72 (b-2)\r\n\nASTM E1578-18 E-3-10\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nNIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\n\n\n\n21 CFR Part 820.72 (b-1)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.6.2.1\r\n\nA2LA C223 5.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.6.1\u20132\r\n\nAIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nISO\/IEC 17025:2017 6.5\r\n\nISO\/TS 22002-4:2013, 4.7.1\r\n\nISO\/TS 22002-6:2016, 4.7\r\n\nOECD GLP Principles 4.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.2\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)\r\n\nUSDA Data and Instrumentation for PDP 6.1\n\n\n10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\n\n\nASTM E1578-18 E-3-11\n\n10.12 The system shall support the use of predefined intervals when calculating instrument event dates.\n\n\n\n21 CFR Part 110.40 (f)\r\n\n21 CFR Part 211.105 (b)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.5.4 and 5.5.5\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5.4\u20135\r\n\nASTM E1578-18 E-3-12\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1\r\n\nIFS Food 7, Part 2, 5.4.1\r\n\nIFS PACsecure 2, Part 2, 5.4.1\r\n\nISO 15189:2012 5.3.1.7\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nISO\/IEC 17025:2017 6.4.13\r\n\nNIST 800-53, Rev. 5, CM-8\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\nUSDA Administrative Procedures for the PDP 7.2\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4\r\n\nWHO Technical Report Series, #961, Annex 13, 6.1\n\n\n10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\n\n\nASTM E1578-18 E-3-13\n\n10.14 The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\n\n\n\n10 CFR Part 20.2103\r\n\n21 CFR Part 58.63\r\n\n21 CFR Part 111.117\r\n\n21 CFR Part 211.67\u201368\r\n\n21 CFR Part 211.160 (b-4)\r\n\n21 CFR Part 211.182\r\n\n21 CFR Part 211.194 (d)\r\n\n21 CFR Part 212.30 (b)\r\n\n21 CFR Part 212.60 (e)\r\n\n21 CFR Part 820.70 (g)\r\n\n21 CFR Part 820.72\r\n\n42 CFR Part 493.1254\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 4.13.2.1\r\n\nA2LA C211 5.5.2\r\n\nA2LA C211 5.10.4\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5\r\n\nABFT Accreditation Manual Sec. E-20 and -23\r\n\nABFT Accreditation Manual Sec. F-1 and I-1\r\n\nAIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\nASTM E1578-18 E-3-14\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.2.1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nISO 15189:2012 5.3.1.4\r\n\nISO\/IEC 17025:2017 6.4.4\r\n\nNIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 4.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Data and Instrumentation for PDP 5.4\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c\r\n\nWADA International Standard for Laboratories (ISL) 5.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 15.46\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.15 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\n\n\n\n11. Batch and lot management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 58.105 (a)\r\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nASTM E1578-18 E-4-1\r\n\nEPA ERLN Laboratory Requirements 3.3\r\n\nEPA ERLN Laboratory Requirements 4.10.1\r\n\nOECD GLP Principles 6.2\n\n\n11.1 The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\n\n\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nASTM E1578-18 E-4-2\r\n\nEPA ERLN Laboratory Requirements 4.10.1\n\n\n11.2 The system shall maintain the links between component parts of a batch and track the batch throughout the system.\n\n\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 820.65\r\n\nASTM E1578-18 E-4-3\n\n\n11.3 The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\n\n\nASTM E1578-18 E-4-4\n\n11.4 The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\n\n\nE.U. Annex 11-15\n\n11.5 The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\n\n\n\n12. Scheduled event management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 129.80 (g)\r\nASTM E1578-18 E-5-1\r\nUSDA Sampling Procedures for PDP 5.6\u20137\n\n12.1 The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.\n\n\n21 CFR Part 212.61 (a)\r\n21 CFR Part 211.166 (b)\r\nASTM E1578-18 E-5-2\n\n12.2 The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.\n\n\nASTM E1578-18 E-5-3\n\n12.3 The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\n\n\nASTM E1578-18 E-5-4\n\n12.4 The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).\n\n\nASTM E1578-18 E-5-5\n\n12.5 The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\n\n\n\n13. Instrument data capture and control \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-6-1\n\n13.1 The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\n\n\nASTM E1578-18 E-6-2\n\n13.2 The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\n\n\nASTM E1578-18 E-6-3\n\n13.3 The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\n\n\nASTM E1578-18 E-6-4\n\n13.4 The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\n\n\nASTM E1578-18 E-6-5\n\n13.5 The system should be able to accept the results uploaded from an interfaced instrument.\n\n\nASTM E1578-18 E-6-6\n\n13.6 The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\n\n\nASTM E1578-18 E-6-7\n\n13.7 The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\n\n\nASTM E1578-18 E-6-8\n\n13.8 The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\n\n\n\n14. Standard and reagent management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 58.83\r\n\n29 CFR Part 1910.1200 (g)\r\n\n29 CFR Part 1910.1450 (h)\r\n\n42 CFR Part 493.1252 (c)\r\n\nABFT Accreditation Manual Sec. E-17\r\n\nASTM E1578-18 E-7-1\r\n\nISO 15189:2012 5.3.2.4\u20135\r\n\nOECD GLP Principles 4.4\n\n\n14.1 The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\n\n\n\n7 CFR Part 331.3\r\n\n9 CFR Part 121.3\r\n\n21 CFR Part 312.58 (b)\r\n\n42 CFR Part 73.3\u20134 (c)\r\n\nASTM E1578-18 E-7-2\r\n\nEPA ERLN Laboratory Requirements 4.1.12\r\n\nISO 15189:2012 5.3.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 12.20\n\n\n14.2 The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\n\n\nASTM E1578-18 E-7-3\r\nISO 15189:2012 5.3.2.4\n\n14.3 The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\n\n\nASTM E1578-18 E-7-4\r\nISO 15189:2012 5.3.2.4\n\n14.4 The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\n\n\nASTM E1578-18 E-7-5\r\nISO 15189:2012 5.3.2.4\n\n14.5 The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\n\n\n\n15. Inventory management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-8-1\r\nCAP Laboratory Accreditation Manual\r\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples and specimens.\n\n\n\n21 CFR Part 212.60 (d)\r\n\nASTM E1578-18 E-8-2\r\n\nCLSI QMS22 2.1.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.2 The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\n\n\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.101\r\n\n21 CFR Part 212.60 (d)\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 606.120 (b)\r\n\n29 CFR Part 1910.1030 (g)\r\n\n29 CFR Part 1910.1096 (e-6)\r\n\n29 CFR Part 1910.1200 (f-6) and (f-10)\r\n\n40 CFR Part 262.206\r\n\nASTM E1578-18 E-8-3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOSHA 1910.1200(b)(3) and (f)\r\n\nOSHA 1910.1450(h)\r\n\nWHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41\r\n\nWHO Technical Report Series, #986, Annex 2, 15.10\u201312\n\n\n15.3 The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\n\n\n\n21 CFR Part 117.420\r\n\n21 CFR Part 212.40 (c)\r\n\n21 CFR Part 820.50\r\n\nA2LA C211 4.6\r\n\nASTM E1578-18 E-8-4\r\n\nBRC GSFS, Issue 8, 3.5.1.4\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5\r\n\nIFS Food 7, Part 2, 4.4.1\r\n\nIFS PACsecure 2, Part 2, 4.4.1\r\n\nISO\/TS 22002-1:2009, 9.2\r\n\nISO\/TS 22002-4:2013, 4.6.2\r\n\nISO\/TS 22002-6:2016, 4.6.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.4.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)\r\n\nUSDA Administrative Procedures for the PDP 7.1\r\n\nWHO Technical Report Series, #961, Annex 13, 7.1 and 7.3\r\n\nWHO Technical Report Series, #986, Annex 2, 14.8\n\n\n15.4 The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\n\n\n\n21 CFR Part 211.196\r\n\n21 CFR Part 212.90\r\n\n21 CFR Part 225.110\r\n\n21 CFR Part 606.165\r\n\n29 CFR Part 1910.1450 Appendix A (I)\r\n\nA2LA C211 4.6\r\n\nASTM E1578-18 E-8-5\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5\n\n\n15.5 The system should provide a means for accurately recording the receipt, approval, distribution, and disposal of materials.\n\n\n\n21 CFR Part 211.82 (b)\r\n\n21 CFR Part 211.84 (a)\r\n\n21 CFR Part 211.89\r\n\n21 CFR Part 211.110 (d)\r\n\n21 CFR Part 211.142 (a)\r\n\n21 CFR Part 212.40 (c)\r\n\nASTM E1578-18 E-8-6\r\n\nWHO Technical Report Series, #986, Annex 2, 12.18\n\n\n15.6 The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\n\n\n\n21 CFR Part 211.89\r\n\n21 CFR Part 211.110 (d)\r\n\n42 CFR Part 493.1252 (d)\r\n\nASTM E1578-18 E-8-7\n\n\n15.7 The system should allow authorized personnel to retire faulty or poor quality materials from use.\n\n\n\n21 CFR Part 211.89\r\nASTM E1578-18 E-8-8\n\n\n15.8 The system shall clearly designate a standard or reagent as being disposed or consumed.\n\n\n\n16. Investigation and quality management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 312.62 (b)\r\n21 CFR Part 812.140 (a-3)\n\n16.1 The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\n\n\n\n21 CFR Part 312.57 (a)\r\n\n21 CFR Part 312.62 (a)\r\n\n21 CFR Part 606.165\r\n\n21 CFR Part 812.140 (a-2) and (b-2)\n\n\n16.2 The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\n\n\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 58.81 (a)\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.111\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 211.194\r\n\n21 CFR Part 606.171\r\n\n42 CFR Part 493.1253 (b-2)\r\n\nA2LA C211 5.4\r\n\nABFT Accreditation Manual C-16\r\n\nABFT Accreditation Manual F-2\r\n\nABFT Accreditation Manual J-3\r\n\nASTM E1578-18 E-9-1\r\n\nBRC GSFS, Issue 8, 5.6.2.3\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nCLSI QMS22 2.2.2.2\r\n\nEPA ERLN Laboratory Requirements 3.3\r\n\nEPA QA\/G-5 2.2.4\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\nISO\/IEC 17025:2017 7.2.1.7\r\n\nISO\/IEC 17025:2017 7.2.2.1\r\n\nISO\/IEC 17025:2017 7.10.2\r\n\nISO\/IEC 17025:2017 8.7.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 7.3\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)\r\n\nUSDA Administrative Procedures for the PDP 8.2.2\r\n\nWADA International Standard for Laboratories (ISL) 5.3.6\r\n\nWHO Technical Report Series, #986, Annex 2, 16.3\n\n\n16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\n\n\n42 CFR Part 493.1282\r\nASTM E1578-18 E-9-2\r\nE.U. Commission Reg. No. 2073\/2005 Article 9\n\n16.4 The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\n\n\n\n21 CFR Part 606.100 (c)\r\n\n42 CFR Part 493.1282\r\n\nASTM E1578-18 E-9-3\r\n\nCLSI QMS22 2.1.2.1\r\n\nCLSI QMS22 2.2.2.3\r\n\nEPA QA\/G-5 2.2.10\r\n\nWHO Technical Report Series, #986, Annex 2, 17.12\r\n\nWHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.5 The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\n\n\n\n10 CFR Part 30.34 (g)\r\n\n21 CFR Part 112.147\r\n\n21 CFR Part 225.58 (d)\r\n\n21 CFR Part 225.158\r\n\n21 CFR Part 606.100 (c)\r\n\n21 CFR Part 820.100\r\n\n42 CFR Part 493.1282\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nA2LA C211 4.9 and 4.11\r\n\nASTM E1578-18 E-9-4\r\n\nBRC GSFS, Issue 8, 3.4.3\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCLSI QMS22 2.6.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nFDA Hazard Analysis Critical Control Point Principle 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5, IR-5\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\nWADA International Standard for Laboratories (ISL) 5.3.9\r\n\nWHO Technical Report Series, #961, Annex 13, 11.1\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\r\n\nWHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\n\n\n\n21 CFR Part 225.58 (d)\r\n\n21 CFR Part 225.158\r\n\n42 CFR Part 493.1282\r\n\n42 CFR Part 493.1289\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nA2LA C211 4.8 and 4.11\r\n\nASTM E1578-18 E-9-5\r\n\nBRC GSFS, Issue 8, 3.4.3\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.3.4\r\n\nCJIS Security Policy Appendix G.7\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nFDA Hazard Analysis Critical Control Point Principle 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5, AU-6(1)\r\n\nNIST 800-53, Rev. 5, IR-4(1) and IR-5\r\n\nNIST 800-53, Rev. 5, SI-2 and SI-4\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\n\n\n16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\n\n\nASTM E1578-18 E-9-6\n\n16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\n\n\n9 CFR Part 2.35\n\n16.9 The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#9._Compliance_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#9._Compliance_management<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 2 May 2022, at 22:08.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2,552 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","c4fcb640c65b0c1a19ddb8ac2a708071_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Maintaining_Laboratory_Workflow_and_Operations rootpage-LII_LIMSpec_Maintaining_Laboratory_Workflow_and_Operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Maintaining Laboratory Workflow and Operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"7._Document_and_records_management\">7. Document and records management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/part-20\" target=\"_blank\">10 CFR Part 20 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.213\u201314<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(e) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.1<\/b> The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.214<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.300\" target=\"_blank\">42 CFR Part 93.300\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1773\" target=\"_blank\">42 CFR Part 493.1773 (c\u2013d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/160.310\" target=\"_blank\">45 CFR Part 160.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 Appendix H5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.2<\/b> The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.3<\/b> The system shall be able to clearly provide the most current version of a document and archive prior versions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.4<\/b> The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.91 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.14<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.5<\/b> The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-12, -14, and -15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.13<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.6<\/b> The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.10\" target=\"_blank\">7 CFR Part 331.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (j-3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.210\" target=\"_blank\">40 CFR Part 262.210\u201312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.7<\/b> The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.8<\/b> The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.9<\/b> The system shall support the addition of accurate cross-references and page numbers to new documents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.10<\/b> The system shall be capable of uniquely identifying documents created in and added to the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>7.11<\/b> The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"8._Resource_management\">8. Resource management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (m)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-3 and -4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.1<\/b> The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.198\" target=\"_blank\">21 CFR Part 820.198<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1233\" target=\"_blank\">42 CFR Part 493.1233<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.10.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.2<\/b> The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123<\/a> 21 CFR Part 123.10]<br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.3<\/b> The system shall allow training sessions and reviews to be scheduled for personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.4<\/b> The system should provide access to relevant training materials to personnel attending training sessions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2\u2013AT-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.5<\/b> The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.6<\/b> The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.7<\/b> The system should be able to produce a training matrix of personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (various parts)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.8<\/b> The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"9._Compliance_management\">9. Compliance management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.1<\/b> The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-2 and AU-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.2<\/b> The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3 and AU-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.3<\/b> The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.4<\/b> The system's audit trail shall document the previous and current value of a modified field.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.5<\/b> The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>9.6<\/b> The system shall prevent a user from copying and pasting the electronic signature of another user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6 and AU-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.7<\/b> The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"10._Instrument_and_equipment_management\">10. Instrument and equipment management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.1<\/b> The system should provide a means for tracking usage of laboratory equipment and instruments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.2<\/b> The system shall provide a means for planning the use of and reserving equipment and instruments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.3<\/b> The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.4<\/b> The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.5<\/b> The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.6<\/b> The system shall be able to group instruments together in specific ways, including by type and laboratory location.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.60\" target=\"_blank\">21 CFR Part 606.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (b-3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2 and MA-2(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.7<\/b> The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.8<\/b> The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.9<\/b> The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.10<\/b> The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.6.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.11<\/b> The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.12<\/b> The system shall support the use of predefined intervals when calculating instrument event dates.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.4 and 5.5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.13<\/b> The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-13<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.14<\/b> The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.63\" target=\"_blank\">21 CFR Part 58.63<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.182\" target=\"_blank\">21 CFR Part 211.182<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1254\" target=\"_blank\">42 CFR Part 493.1254<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20 and -23<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. F-1 and I-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.46<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.15<\/b> The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"11._Batch_and_lot_management\">11. Batch and lot management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.1<\/b> The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.2<\/b> The system shall maintain the links between component parts of a batch and track the batch throughout the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.65\" target=\"_blank\">21 CFR Part 820.65<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.3<\/b> The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>11.4<\/b> The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-15<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>11.5<\/b> The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"12._Scheduled_event_management\">12. Scheduled event management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.6\u20137<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.1<\/b> The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.2<\/b> The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.3<\/b> The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.4<\/b> The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.5<\/b> The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"13._Instrument_data_capture_and_control\">13. Instrument data capture and control<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.1<\/b> The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.2<\/b> The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.3<\/b> The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.4<\/b> The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.5<\/b> The system should be able to accept the results uploaded from an interfaced instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.6<\/b> The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.7<\/b> The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.8<\/b> The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"14._Standard_and_reagent_management\">14. Standard and reagent management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.83\" target=\"_blank\">21 CFR Part 58.83<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>14.1<\/b> The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.3\" target=\"_blank\">7 CFR Part 331.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.3\" target=\"_blank\">9 CFR Part 121.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.3\" target=\"_blank\">42 CFR Part 73.3\u20134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.20<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>14.2<\/b> The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.3<\/b> The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.4<\/b> The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.5<\/b> The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"15._Inventory_management\">15. Inventory management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>15.1<\/b> The system should be capable of accurately tracking the specific quantities of received and consumed test samples and specimens.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.2<\/b> The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (f-6) and (f-10)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.206\" target=\"_blank\">40 CFR Part 262.206<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.10\u201312<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.3<\/b> The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.50\" target=\"_blank\">21 CFR Part 820.50<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.4<\/b> The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.196\" target=\"_blank\">21 CFR Part 211.196<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.90\" target=\"_blank\">21 CFR Part 212.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 Appendix A (I)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.5<\/b> The system should provide a means for accurately recording the receipt, approval, distribution, and disposal of materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.82\" target=\"_blank\">21 CFR Part 211.82 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.142\" target=\"_blank\">21 CFR Part 211.142 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.6<\/b> The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.7<\/b> The system should allow authorized personnel to retire faulty or poor quality materials from use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.8<\/b> The system shall clearly designate a standard or reagent as being disposed or consumed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"16._Investigation_and_quality_management\">16. Investigation and quality management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.1<\/b> The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-2) and (b-2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.2<\/b> The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.81\" target=\"_blank\">21 CFR Part 58.81 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.171\" target=\"_blank\">21 CFR Part 606.171<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1253\" target=\"_blank\">42 CFR Part 493.1253 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual F-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual J-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.3<\/b> The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.4<\/b> The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.5<\/b> The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.147<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.100\" target=\"_blank\">21 CFR Part 820.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.9 and 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 11.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.6<\/b> The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1289\" target=\"_blank\">42 CFR Part 493.1289<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.8 and 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-4(1) and IR-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2 and SI-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.7<\/b> The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.8<\/b> The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.9<\/b> The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173541\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.104 seconds\nReal time usage: 0.111 seconds\nPreprocessor visited node count: 1035\/1000000\nPost\u2010expand include size: 141529\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 20.237 1 -total\n 11.99% 2.426 1 Template:LIMSpec\/Document_management\n 10.55% 2.135 1 Template:LIMSpec\/Resource_management\n 9.87% 1.998 1 Template:LIMSpec\/Instrument_and_equipment_management\n 9.68% 1.958 1 Template:LIMSpec\/Compliance_management\n 9.13% 1.848 1 Template:LIMSpec\/Batch_and_lot_management\n 9.07% 1.836 1 Template:LIMSpec\/Investigation_and_quality_management\n 8.97% 1.815 1 Template:LIMSpec\/Inventory_management\n 8.81% 1.782 1 Template:LIMSpec\/Scheduled_event_management\n 8.72% 1.764 1 Template:LIMSpec\/Instrument_data_capture_and_control\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11181-0!canonical and timestamp 20221202173541 and revision id 47569. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#9._Compliance_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#9._Compliance_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","c4fcb640c65b0c1a19ddb8ac2a708071_images":[],"c4fcb640c65b0c1a19ddb8ac2a708071_timestamp":1670002542,"fe6f7831accf9866e7094abebdb6a6a1_type":"article","fe6f7831accf9866e7094abebdb6a6a1_title":"8. Resource management","fe6f7831accf9866e7094abebdb6a6a1_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#8._Resource_management","fe6f7831accf9866e7094abebdb6a6a1_plaintext":"\n\nLII:LIMSpec\/Maintaining Laboratory Workflow and OperationsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.\n\n7. Document and records management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n7 CFR Part 331 (throughout)\r\n\n9 CFR Part 121 (throughout)\r\n\n10 CFR Part 20 (throughout)\r\n\n21 CFR Part 7 (throughout)\r\n\n21 CFR Part 117 (throughout)\r\n\n21 CFR Part 58 (throughout)\r\n\n21 CFR Part 211 (throughout)\r\n\n21 CFR Part 212 (throughout)\r\n\n21 CFR Part 225 (throughout)\r\n\n21 CFR Part 226 (throughout)\r\n\n21 CFR Part 312 (throughout)\r\n\n21 CFR Part 606 (throughout)\r\n\n21 CFR Part 810 (throughout)\r\n\n21 CFR Part 812 (throughout)\r\n\n21 CFR Part 820 (throughout)\r\n\n29 CFR Part 1910.134 (throughout)\r\n\n29 CFR Part 1910.1030 (throughout)\r\n\n29 CFR Part 1910.1200 (throughout)\r\n\n29 CFR Part 1910.1450 (throughout)\r\n\n40 CFR Part 262.213\u201314\r\n\n42 CFR Part 73 (throughout)\r\n\n42 CFR Part 493.1200\r\n\n42 CFR Part 493.1232\r\n\n42 CFR Part 493.1239\r\n\n42 CFR Part 493.1251\r\n\n42 CFR Part 493.1291 (j)\r\n\n45 CFR Part 164 (throughout)\r\n\n61 FR 38806 (throughout)\r\n\nA2LA C211 4.3\r\n\nA2LA C223 4.13\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\nAAVLD Requirements for an AVMDL (throughout)\r\n\nABFT Accreditation Manual (throughout)\r\n\nASTM E1188-11 3.5.2\r\n\nASTM E1492-11 4.3.3.3 and 4.4.4\r\n\nASTM E1578-18 D-1-1\r\n\nBRC GSFS, Issue 8, 3.1.1\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nBRC GSFS, Issue 8, 5.6.1.1\r\n\nBRC GSFS, Issue 8, 5.6.2.2\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual (throughout)\r\n\nCJIS Security Policy (throughout)\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)\r\n\nEPA 815-R-05-004 (throughout)\r\n\nEPA ERLN Laboratory Requirements (throughout)\r\n\nEPA QA\/G-5 (throughout)\r\n\nE.U. Commission Directive 2003\/94\/EC (throughout)\r\n\nFDA Hazard Analysis Critical Control Point (throughout)\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\nIFS Food 7, Part 2 (throughout)\r\n\nIFS PACsecure 2, Part 2 (throughout)\r\n\nISO 15189:2012 4.3\r\n\nISO 15189:2012 5.5.3\r\n\nISO 15189:2012 5.9.3\r\n\nISO\/IEC 17025:2017 5.3\r\n\nISO\/IEC 17025:2017 5.5\r\n\nISO\/IEC 17025:2017 8.3.2\r\n\nISO\/TS 22002-1:2009 (throughout)\r\n\nISO\/TS 22002-4:2013 (throughout)\r\n\nISO\/TS 22002-6:2016 (throughout)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5 (throughout)\r\n\nOECD GLP Principles 8\r\n\nOSHA 1910.1200(b)(3)\r\n\nOSHA 1910.1450(e) and (h)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\nSQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nUSDA Data and Instrumentation for PDP (throughout)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\nWHO Technical Report Series, #961, Annex 13 (throughout)\r\n\nWHO Technical Report Series, #986, Annex 2 (throughout)\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\n\n\n\n7 CFR Part 331 (throughout)\r\n\n9 CFR Part 121 (throughout)\r\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 7 (throughout)\r\n\n21 CFR Part 58 (throughout)\r\n\n21 CFR Part 117 (throughout)\r\n\n21 CFR Part 211 (throughout)\r\n\n21 CFR Part 212 (throughout)\r\n\n21 CFR Part 225 (throughout)\r\n\n21 CFR Part 226 (throughout)\r\n\n21 CFR Part 312 (throughout)\r\n\n21 CFR Part 606 (throughout)\r\n\n21 CFR Part 810 (throughout)\r\n\n21 CFR Part 812 (throughout)\r\n\n21 CFR Part 820 (throughout)\r\n\n29 CFR Part 1910.134 (c)\r\n\n29 CFR Part 1910.1030 (throughout)\r\n\n29 CFR Part 1910.1200 (e)\r\n\n29 CFR Part 1910.1450 (throughout)\r\n\n40 CFR Part 262.214\r\n\n42 CFR Part 73 (throughout)\r\n\n42 CFR Part 93.300\u20135\r\n\n42 CFR Part 493.1200\r\n\n42 CFR Part 493.1232\r\n\n42 CFR Part 493.1239\r\n\n42 CFR Part 493.1251\r\n\n42 CFR Part 493.1291 (j)\r\n\n42 CFR Part 493.1773 (c\u2013d)\r\n\n45 CFR Part 160.310\r\n\n45 CFR Part 164 (throughout)\r\n\n61 FR 38806 (throughout)\r\n\nA2LA C211 (throughout)\r\n\nA2LA C223 (throughout)\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\nAAVLD Requirements for an AVMDL (throughout)\r\n\nACMG Technical Standards for Clinical Genetics Laboratories (throughout)\r\n\nAIHA-LAP Policies 2022 Appendix H5.8\r\n\nASTM E1188-11 3.5.2\r\n\nASTM E1492-11 4.3.3.3 and 4.4.4\r\n\nASTM E1578-18 D-1-2\r\n\nBRC GSFS, Issue 8, 3.1.2\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nBRC GSFS, Issue 8, 5.6.2.2\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual (throughout)\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)\r\n\nCJIS Security Policy (throughout)\r\n\nCLSI QMS22 (throughout)\r\n\nEPA 815-R-05-004 (throughout)\r\n\nEPA ERLN Laboratory Requirements (throughout)\r\n\nEPA QA\/G-5 (throughout)\r\n\nE.U. Commission Directive 2003\/94\/EC (throughout)\r\n\nFDA Hazard Analysis Critical Control Point (throughout)\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\nIFS Food 7, Part 2 (throughout)\r\n\nIFS PACsecure 2, Part 2 (throughout)\r\n\nISO 15189:2012 (throughout)\r\n\nISO\/IEC 17025:2017 (throughout)\r\n\nISO\/TS 22002-1:2009 (throughout)\r\n\nISO\/TS 22002-4:2013 (throughout)\r\n\nISO\/TS 22002-6:2016 (throughout)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5 (throughout)\r\n\nOECD GLP Principles 8\r\n\nOSHA 1910.1020 (throughout)\r\n\nOSHA 1910.1200(b)(3)\r\n\nOSHA 1910.1450(h)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\nSQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nUSDA Data and Instrumentation for PDP (throughout)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines (throughout)\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3\r\n\nUSDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\nWADA International Standard for Laboratories (ISL) (throughout)\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\r\n\nWHO Technical Report Series, #961, Annex 13 (throughout)\r\n\nWHO Technical Report Series, #986, Annex 2 (throughout)\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.2 The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\n\n\n\n21 CFR Part 1.1154 (c)\r\n\n21 CFR Part 820.40 (a)\r\n\n42 CFR Part 493.1251 (e)\r\n\nA2LA C211 4.3\r\n\nAAVLD Requirements for an AVMDL Sec. 4.3\r\n\nASTM E1578-18 D-1-3\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nEPA 815-R-05-004 Chap. III, Sec. 11\r\n\nEPA ERLN Laboratory Requirements 4.2.4.2\r\n\nEPA QA\/G-5 2.1.9\r\n\nISO 15189:2012 4.3\r\n\nISO 15189:2012 5.5.3\r\n\nISO 15189:2012 5.9.3\r\n\nISO\/IEC 17025:2017 7.5.2\r\n\nISO\/IEC 17025:2017 8.3.2\r\n\nUSDA Administrative Procedures for the PDP 5.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.5\n\n\n7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.\n\n\nASTM E1578-18 D-1-4\n\n7.4 The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1151\r\n\n21 CFR Part 1.1152 (e)\r\n\n21 CFR Part 106.91 (c)\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.315\r\n\n21 CFR Part 111.320\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.160\r\n\n21 CFR Part 212.20 (c)\r\n\n21 CFR Part 212.60 (c)\r\n\n21 CFR Part 226.58 (e)\r\n\n21 CFR Part 820.250 (b)\r\n\n42 CFR Part 493.43 (c)\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nASTM E1578-18 D-1-5\r\n\nBRC GSFS, Issue 8, 5.6.1.1\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.3\r\n\nCodex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\nCodex Alimentarius CXS 234-1999 (throughout)\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 5\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\nIFS Food 7, Part 2, 5.5.2\r\n\nIFS Food 7, Part 2, 5.6.2\r\n\nIFS PACsecure 2, Part 2, 5.5.2\r\n\nIFS PACsecure 2, Part 2, 5.6.2\r\n\nISO\/IEC 17025:2017 6.5\r\n\nISO\/IEC 17025:2017 7.2.1.3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)\r\n\nUSDA Administrative Procedures for the PDP 8.4\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1\r\n\nWHO Technical Report Series, #986, Annex 2, 15.14\n\n\n7.5 The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1151\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.320\r\n\n21 CFR Part 212.20 (c)\r\n\n21 CFR Part 212.70 (b)\r\n\nA2LA C211 5.4.5\r\n\nA2LA C223 5.4\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.4\r\n\nABFT Accreditation Manual Sec. G-12, -14, and -15\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C10\r\n\nACMG Technical Standards for Clinical Genetics Laboratories F7.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4\r\n\nCodex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\nCodex Alimentarius CXS 234-1999 (throughout)\r\n\nEPA QA\/G-5 2.2.4\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\nISO\/IEC 17025:2017 7.2.2.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\nUSDA Administrative Procedures for the PDP 8.4\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6\r\n\nWHO Technical Report Series, #961, Annex 13, 10.1\r\n\nWHO Technical Report Series, #986, Annex 2, 4.11\r\n\nWHO Technical Report Series, #986, Annex 2, 15.13\n\n\n7.6 The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\n\n\n\n7 CFR Part 331.10\r\n\n7 CFR Part 331.15\r\n\n9 CFR Part 2.32\r\n\n9 CFR Part 121.10 \r\n\n9 CFR Part 121.15 \r\n\n10 CFR Part 30.34 (j-3)\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 11.10 (i)\r\n\n21 CFR Part 58.29\r\n\n21 CFR Part 211.25\r\n\n21 CFR Part 225.10\r\n\n21 CFR Part 226.10\r\n\n21 CFR Part 226.40\r\n\n21 CFR Part 820.25\r\n\n29 CFR Part 1910.134 (c)\r\n\n29 CFR Part 1910.1030 (g-2)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n29 CFR Part 1910.1200 (h)\r\n\n29 CFR Part 1910.1450 (f)\r\n\n40 CFR Part 262.207\r\n\n40 CFR Part 262.210\u201312\r\n\n42 CFR Part 73.10\r\n\n42 CFR Part 73.15\r\n\n42 CFR Part 493.43 (c)\r\n\n42 CFR Part 493.1235\r\n\n42 CFR Part 493.1251\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 417.5\r\n\nA2LA C211 5.2\r\n\nA2LA C223 5.2\r\n\nA2LA C223 5.7\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\nAAVLD Requirements for an AVMDL Appendix 1\r\n\nABFT Accreditation Manual Sec. B\r\n\nACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.4\r\n\nAIHA-LAP Policies 2022 (throughout)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASTM E1578-18 C-3-5\r\n\nASTM E1578-18 D-1-6\r\n\nASTM E1578-18 E-1-6\r\n\nBRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nCAP Laboratory Accreditation Manual\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCLSI QMS22 (throughout)\r\n\nE.U. Annex 11-2\r\n\nE.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\nEPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 1\r\n\nEPA QA\/G-5 2.1.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.1\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.1\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nISO 15189:2012 4.1.2.1\r\n\nISO 15189:2012 5.1.6\r\n\nISO 15189:2012 5.1.9\r\n\nISO\/IEC 17025:2017 6.2.2\r\n\nISO\/IEC 17025:2017 6.2.3\r\n\nISO\/IEC 17025:2017 6.2.5\r\n\nISO\/IEC 17025:2017 6.2.6\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nOECD GLP Principles 1.1.2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\n\n\n7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n\n\nASTM E1578-18 D-1-7\n\n7.8 The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\n\n\nAAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5\r\nEPA ERLN Laboratory Requirements 4.10.6\n\n7.9 The system shall support the addition of accurate cross-references and page numbers to new documents.\n\n\nAAVLD Requirements for an AVMDL Sec. 4.3.4\n\n7.10 The system shall be capable of uniquely identifying documents created in and added to the system.\n\n\nAPHL 2019 LIS Project Management Guidebook\r\n\n\n7.11 The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\n\n\n\n8. Resource management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n9 CFR Part 2.32\r\n\n10 CFR Part 20.2103\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 110.10 (c)\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.10\r\n\n29 CFR Part 1910.120\r\n\n29 CFR Part 1910.134 (m)\r\n\n29 CFR Part 1910.1030 (h-1)\r\n\n29 CFR Part 1910.1450 (j)\r\n\n40 CFR Part 262.207\r\n\nA2LA C211 4.13.2.3\r\n\nA2LA C223 5.2\r\n\nA2LA C223 5.7\r\n\nACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nBRC GSFS, Issue 8, 7.3.1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.2.3\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nEPA QA\/G-5 2.1.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.1\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.1\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nNIST 800-53, Rev. 5, AT-3 and -4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOSHA 1910.1020 (throughout)\r\n\nOSHA 1910.1200(b)(3) and (h)\r\n\nOSHA 1910.1450 (throughout)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nUSDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\r\n\nWHO Technical Report Series, #996, Annex 5, 8.1\n\n\n8.1 The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\n\n\n\n21 CFR Part 820.198\r\n\n42 CFR Part 493.1233\r\n\nBRC GSFS, Issue 8, 3.10.1\u20132\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21\r\n\nIFS Food 7, Part 2, 5.8\r\n\nIFS PACsecure 2, Part 2, 5.8\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)\r\n\nWADA International Standard for Laboratories (ISL) 5.3.10\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\n\n\n8.2 The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.\n\n\n\n5 CFR Part 930.301\r\n\n7 CFR Part 331.15\r\n\n9 CFR Part 121.15\r\n\n21 CFR Part 120.12\r\n\nhttps:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123 21 CFR Part 123.10]\r\n\n21 CFR Part 211.25\r\n\n29 CFR Part 1910.1450 (f)\r\n\n42 CFR Part 73.15\r\n\nA2LA C223 5.2\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3\r\n\nASTM E1578-18 E-1-1\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nCJIS Security Policy 5.2.1\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nNIST 800-53, Rev. 5, AT-2 and AT-3\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Sampling Procedures for PDP 6.1.2\u20133\r\n\nWHO Technical Report Series, #986, Annex 2, 10\n\n\n8.3 The system shall allow training sessions and reviews to be scheduled for personnel.\n\n\n\n5 CFR Part 930.301\r\n\n29 CFR Part 1910.1450 (f)\r\n\nABFT Accreditation Manual Sec. B\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7\r\n\nASTM E1578-18 E-1-2\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.4 The system should provide access to relevant training materials to personnel attending training sessions.\n\n\n\n5 CFR Part 930.301\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 110.10 (c)\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.10\r\n\n29 CFR Part 1910.1450 (f)\r\n\n40 CFR Part 262.207\r\n\nA2LA C223 5.2\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5\r\n\nASTM E1578-18 E-1-3\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.2.3\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nEPA QA\/G-5 2.1.8\r\n\nE.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nISO 15189:2012 5.1.9\r\n\nNIST 800-53, Rev. 5, AT-2\u2013AT-4\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e\r\n\nUSDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (e)\r\n\nWHO Technical Report Series, #986, Annex 2, 9.4\r\n\nWHO Technical Report Series, #986, Annex 2, 10\n\n\n8.5 The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\n\n\n\nABFT Accreditation Manual Sec. B\r\n\nASTM E1578-18 E-1-4\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\n\n\n8.6 The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\n\n\n\nASTM E1578-18 E-1-5\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nNIST 800-53, Rev. 5, AT-2 and AT-3\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.7 The system should be able to produce a training matrix of personnel.\n\n\n\n7 CFR Part 331.15\r\n\n9 CFR Part 121.10 \r\n\n9 CFR Part 121.15 \r\n\n21 CFR Part 11.10 (i)\r\n\n21 CFR Part 58.29\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 211.25\r\n\n21 CFR Part 225.10\r\n\n21 CFR Part 226.10\r\n\n21 CFR Part 226.40\r\n\n21 CFR Part 820.25\r\n\n29 CFR Part 1910.1030 (g-2)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n29 CFR Part 1910.1200 (h)\r\n\n29 CFR Part 1910.1450 (e)\r\n\n42 CFR Part 73.10\r\n\n42 CFR Part 73.15\r\n\n42 CFR Part 493.43 (c)\r\n\n42 CFR Part 493.1235\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nA2LA C223 5.2\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\nAAVLD Requirements for an AVMDL Appendix 1\r\n\nABFT Accreditation Manual Sec. B\r\n\nAIHA-LAP Policies 2022 (various parts)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASTM E1578-18 C-3-5\r\n\nASTM E1578-18 D-1-6\r\n\nASTM E1578-18 E-1-6\r\n\nBRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nE.U. Annex 11-2\r\n\nEPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 1\r\n\nEPA QA\/G-5 2.1.8\r\n\nISO 15189:2012 4.1.2.1\r\n\nISO 15189:2012 5.1.6\r\n\nISO 15189:2012 5.1.9\r\n\nISO\/IEC 17025:2017 6.2.2\r\n\nISO\/IEC 17025:2017 6.2.3\r\n\nISO\/IEC 17025:2017 6.2.5\r\n\nISO\/IEC 17025:2017 6.2.6\r\n\nOECD GLP Principles 1.1.2\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\n\n\n8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n\n\n\n9. Compliance management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17 \r\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1251 (d)\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nASTM E1578-18 C-4-7\r\n\nASTM E1578-18 E-2-1\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Annex 11-9\r\n\nE.U. Annex 11-14\r\n\nOECD GLP Principles 8.3.5\r\n\nUSDA Data and Instrumentation for PDP 8.1.3\n\n\n9.1 The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-2\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCJIS Security Policy Appendix G.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Annex 11-9\r\n\nE.U. Annex 11-12.4\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nNIST 800-53, Rev. 5, AC-2(4) and AC-6(9)\r\n\nNIST 800-53, Rev. 5, AU-2 and AU-3\r\n\nNIST 800-53, Rev. 5, CM-5(1)\r\n\nOECD GLP Principles 8.3.5\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n9.2 The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1274\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-3\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCLSI QMS22 2.2.3.2\r\n\nCLSI QMS22 2.4.3\r\n\nE.U. Annex 11-12.4\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nNIST 800-53, Rev. 5, AU-3 and AU-8\r\n\nOECD GLP Principles 8.3.5\r\n\nUSDA Data and Instrumentation for PDP 8.1.4\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.3 The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-4\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nICH GCP 4.9.0 and 4.9.3\r\n\nNIST 800-53, Rev. 5, AU-3\r\n\nOECD GLP Principles 8.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.4 The system's audit trail shall document the previous and current value of a modified field.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1251 (d)\r\n\n45 CFR Part 164.310\r\n\nASTM E1578-18 E-2-5\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nE.U. Annex 11-14\r\n\nOECD GLP Principles 8.3.5\n\n\n9.5 The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\n\n\n21 CFR Part 11.70\r\nE.U. Annex 11-14\n\n9.6 The system shall prevent a user from copying and pasting the electronic signature of another user.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 58.130 (e)\r\n\n42 CFR Part 493.1274 (d)\r\n\nE.U. Annex 11-9\r\n\nNIST 800-53, Rev. 5, AU-6 and AU-12\r\n\nOECD GLP Principles 8.3.5\n\n\n9.7 The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\n\n\n\n10. Instrument and equipment management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-3-1\n\n10.1 The system should provide a means for tracking usage of laboratory equipment and instruments.\n\n\nASTM E1578-18 E-3-2\n\n10.2 The system shall provide a means for planning the use of and reserving equipment and instruments.\n\n\nASTM E1578-18 E-3-3\n\n10.3 The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\n\n\nASTM E1578-18 E-3-4\n\n10.4 The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\n\n\nASTM E1578-18 E-3-5\n\n10.5 The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\n\n\nASTM E1578-18 E-3-6\n\n10.6 The system shall be able to group instruments together in specific ways, including by type and laboratory location.\n\n\n\n21 CFR Part 110.40 (f)\r\n\n21 CFR Part 211.67\u201368\r\n\n21 CFR Part 211.160 (b-4)\r\n\n21 CFR Part 212.30 (b)\r\n\n21 CFR Part 212.60 (e)\r\n\n21 CFR Part 225.30 (b-4)\r\n\n21 CFR Part 606.60\r\n\n21 CFR Part 820.70 (g)\r\n\n21 CFR Part 820.72\r\n\n42 CFR Part 493.1252 (b-3)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.5.2\r\n\nA2LA C223 5.5\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5\r\n\nABFT Accreditation Manual Sec. E-20\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1\r\n\nAIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\nASTM E1578-18 E-3-7\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.6.1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nISO 15189:2012 5.3.1.4\r\n\nISO\/IEC 17025:2017 6.4.7\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nISO\/TS 22002-4:2013, 4.7.1\r\n\nISO\/TS 22002-6:2016, 4.7\r\n\nNIST 800-53, Rev. 5, MA-2 and MA-2(2)\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Data and Instrumentation for PDP 5.2\r\n\nUSDA Data and Instrumentation for PDP 6\r\n\nWADA International Standard for Laboratories (ISL) 5.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 13.5\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\n\n\n\n21 CFR Part 225.30 (b-4)\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5.9\r\n\nASTM E1578-18 E-3-8\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.8 The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\n\n\n\n21 CFR Part 211.160 (b-4)\r\n\nA2LA C211 5.5.7\r\n\nA2LA C223 5.6\r\n\nABFT Accreditation Manual Sec. E-21\r\n\nASTM E1578-18 E-3-9\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nCLSI QMS22 2.1.2.1\r\n\nIFS Food 7, Part 2, 5.4.3\r\n\nIFS PACsecure 2, Part 2, 5.4.3\r\n\nISO 15189:2012 5.3.1.5\r\n\nISO\/IEC 17025:2017 6.4.9\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)\r\n\nWHO Technical Report Series, #986, Annex 2, 13.10\n\n\n10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.\n\n\n\n21 CFR Part 111.117\r\n\n21 CFR Part 820.72 (b-2)\r\n\nASTM E1578-18 E-3-10\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nNIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\n\n\n\n21 CFR Part 820.72 (b-1)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.6.2.1\r\n\nA2LA C223 5.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.6.1\u20132\r\n\nAIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nISO\/IEC 17025:2017 6.5\r\n\nISO\/TS 22002-4:2013, 4.7.1\r\n\nISO\/TS 22002-6:2016, 4.7\r\n\nOECD GLP Principles 4.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.2\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)\r\n\nUSDA Data and Instrumentation for PDP 6.1\n\n\n10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\n\n\nASTM E1578-18 E-3-11\n\n10.12 The system shall support the use of predefined intervals when calculating instrument event dates.\n\n\n\n21 CFR Part 110.40 (f)\r\n\n21 CFR Part 211.105 (b)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.5.4 and 5.5.5\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5.4\u20135\r\n\nASTM E1578-18 E-3-12\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1\r\n\nIFS Food 7, Part 2, 5.4.1\r\n\nIFS PACsecure 2, Part 2, 5.4.1\r\n\nISO 15189:2012 5.3.1.7\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nISO\/IEC 17025:2017 6.4.13\r\n\nNIST 800-53, Rev. 5, CM-8\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\nUSDA Administrative Procedures for the PDP 7.2\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4\r\n\nWHO Technical Report Series, #961, Annex 13, 6.1\n\n\n10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\n\n\nASTM E1578-18 E-3-13\n\n10.14 The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\n\n\n\n10 CFR Part 20.2103\r\n\n21 CFR Part 58.63\r\n\n21 CFR Part 111.117\r\n\n21 CFR Part 211.67\u201368\r\n\n21 CFR Part 211.160 (b-4)\r\n\n21 CFR Part 211.182\r\n\n21 CFR Part 211.194 (d)\r\n\n21 CFR Part 212.30 (b)\r\n\n21 CFR Part 212.60 (e)\r\n\n21 CFR Part 820.70 (g)\r\n\n21 CFR Part 820.72\r\n\n42 CFR Part 493.1254\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 4.13.2.1\r\n\nA2LA C211 5.5.2\r\n\nA2LA C211 5.10.4\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5\r\n\nABFT Accreditation Manual Sec. E-20 and -23\r\n\nABFT Accreditation Manual Sec. F-1 and I-1\r\n\nAIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\nASTM E1578-18 E-3-14\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.2.1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nISO 15189:2012 5.3.1.4\r\n\nISO\/IEC 17025:2017 6.4.4\r\n\nNIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 4.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Data and Instrumentation for PDP 5.4\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c\r\n\nWADA International Standard for Laboratories (ISL) 5.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 15.46\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.15 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\n\n\n\n11. Batch and lot management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 58.105 (a)\r\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nASTM E1578-18 E-4-1\r\n\nEPA ERLN Laboratory Requirements 3.3\r\n\nEPA ERLN Laboratory Requirements 4.10.1\r\n\nOECD GLP Principles 6.2\n\n\n11.1 The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\n\n\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nASTM E1578-18 E-4-2\r\n\nEPA ERLN Laboratory Requirements 4.10.1\n\n\n11.2 The system shall maintain the links between component parts of a batch and track the batch throughout the system.\n\n\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 820.65\r\n\nASTM E1578-18 E-4-3\n\n\n11.3 The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\n\n\nASTM E1578-18 E-4-4\n\n11.4 The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\n\n\nE.U. Annex 11-15\n\n11.5 The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\n\n\n\n12. Scheduled event management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 129.80 (g)\r\nASTM E1578-18 E-5-1\r\nUSDA Sampling Procedures for PDP 5.6\u20137\n\n12.1 The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.\n\n\n21 CFR Part 212.61 (a)\r\n21 CFR Part 211.166 (b)\r\nASTM E1578-18 E-5-2\n\n12.2 The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.\n\n\nASTM E1578-18 E-5-3\n\n12.3 The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\n\n\nASTM E1578-18 E-5-4\n\n12.4 The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).\n\n\nASTM E1578-18 E-5-5\n\n12.5 The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\n\n\n\n13. Instrument data capture and control \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-6-1\n\n13.1 The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\n\n\nASTM E1578-18 E-6-2\n\n13.2 The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\n\n\nASTM E1578-18 E-6-3\n\n13.3 The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\n\n\nASTM E1578-18 E-6-4\n\n13.4 The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\n\n\nASTM E1578-18 E-6-5\n\n13.5 The system should be able to accept the results uploaded from an interfaced instrument.\n\n\nASTM E1578-18 E-6-6\n\n13.6 The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\n\n\nASTM E1578-18 E-6-7\n\n13.7 The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\n\n\nASTM E1578-18 E-6-8\n\n13.8 The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\n\n\n\n14. Standard and reagent management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 58.83\r\n\n29 CFR Part 1910.1200 (g)\r\n\n29 CFR Part 1910.1450 (h)\r\n\n42 CFR Part 493.1252 (c)\r\n\nABFT Accreditation Manual Sec. E-17\r\n\nASTM E1578-18 E-7-1\r\n\nISO 15189:2012 5.3.2.4\u20135\r\n\nOECD GLP Principles 4.4\n\n\n14.1 The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\n\n\n\n7 CFR Part 331.3\r\n\n9 CFR Part 121.3\r\n\n21 CFR Part 312.58 (b)\r\n\n42 CFR Part 73.3\u20134 (c)\r\n\nASTM E1578-18 E-7-2\r\n\nEPA ERLN Laboratory Requirements 4.1.12\r\n\nISO 15189:2012 5.3.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 12.20\n\n\n14.2 The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\n\n\nASTM E1578-18 E-7-3\r\nISO 15189:2012 5.3.2.4\n\n14.3 The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\n\n\nASTM E1578-18 E-7-4\r\nISO 15189:2012 5.3.2.4\n\n14.4 The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\n\n\nASTM E1578-18 E-7-5\r\nISO 15189:2012 5.3.2.4\n\n14.5 The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\n\n\n\n15. Inventory management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-8-1\r\nCAP Laboratory Accreditation Manual\r\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples and specimens.\n\n\n\n21 CFR Part 212.60 (d)\r\n\nASTM E1578-18 E-8-2\r\n\nCLSI QMS22 2.1.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.2 The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\n\n\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.101\r\n\n21 CFR Part 212.60 (d)\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 606.120 (b)\r\n\n29 CFR Part 1910.1030 (g)\r\n\n29 CFR Part 1910.1096 (e-6)\r\n\n29 CFR Part 1910.1200 (f-6) and (f-10)\r\n\n40 CFR Part 262.206\r\n\nASTM E1578-18 E-8-3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOSHA 1910.1200(b)(3) and (f)\r\n\nOSHA 1910.1450(h)\r\n\nWHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41\r\n\nWHO Technical Report Series, #986, Annex 2, 15.10\u201312\n\n\n15.3 The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\n\n\n\n21 CFR Part 117.420\r\n\n21 CFR Part 212.40 (c)\r\n\n21 CFR Part 820.50\r\n\nA2LA C211 4.6\r\n\nASTM E1578-18 E-8-4\r\n\nBRC GSFS, Issue 8, 3.5.1.4\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5\r\n\nIFS Food 7, Part 2, 4.4.1\r\n\nIFS PACsecure 2, Part 2, 4.4.1\r\n\nISO\/TS 22002-1:2009, 9.2\r\n\nISO\/TS 22002-4:2013, 4.6.2\r\n\nISO\/TS 22002-6:2016, 4.6.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.4.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)\r\n\nUSDA Administrative Procedures for the PDP 7.1\r\n\nWHO Technical Report Series, #961, Annex 13, 7.1 and 7.3\r\n\nWHO Technical Report Series, #986, Annex 2, 14.8\n\n\n15.4 The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\n\n\n\n21 CFR Part 211.196\r\n\n21 CFR Part 212.90\r\n\n21 CFR Part 225.110\r\n\n21 CFR Part 606.165\r\n\n29 CFR Part 1910.1450 Appendix A (I)\r\n\nA2LA C211 4.6\r\n\nASTM E1578-18 E-8-5\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5\n\n\n15.5 The system should provide a means for accurately recording the receipt, approval, distribution, and disposal of materials.\n\n\n\n21 CFR Part 211.82 (b)\r\n\n21 CFR Part 211.84 (a)\r\n\n21 CFR Part 211.89\r\n\n21 CFR Part 211.110 (d)\r\n\n21 CFR Part 211.142 (a)\r\n\n21 CFR Part 212.40 (c)\r\n\nASTM E1578-18 E-8-6\r\n\nWHO Technical Report Series, #986, Annex 2, 12.18\n\n\n15.6 The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\n\n\n\n21 CFR Part 211.89\r\n\n21 CFR Part 211.110 (d)\r\n\n42 CFR Part 493.1252 (d)\r\n\nASTM E1578-18 E-8-7\n\n\n15.7 The system should allow authorized personnel to retire faulty or poor quality materials from use.\n\n\n\n21 CFR Part 211.89\r\nASTM E1578-18 E-8-8\n\n\n15.8 The system shall clearly designate a standard or reagent as being disposed or consumed.\n\n\n\n16. Investigation and quality management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 312.62 (b)\r\n21 CFR Part 812.140 (a-3)\n\n16.1 The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\n\n\n\n21 CFR Part 312.57 (a)\r\n\n21 CFR Part 312.62 (a)\r\n\n21 CFR Part 606.165\r\n\n21 CFR Part 812.140 (a-2) and (b-2)\n\n\n16.2 The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\n\n\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 58.81 (a)\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.111\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 211.194\r\n\n21 CFR Part 606.171\r\n\n42 CFR Part 493.1253 (b-2)\r\n\nA2LA C211 5.4\r\n\nABFT Accreditation Manual C-16\r\n\nABFT Accreditation Manual F-2\r\n\nABFT Accreditation Manual J-3\r\n\nASTM E1578-18 E-9-1\r\n\nBRC GSFS, Issue 8, 5.6.2.3\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nCLSI QMS22 2.2.2.2\r\n\nEPA ERLN Laboratory Requirements 3.3\r\n\nEPA QA\/G-5 2.2.4\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\nISO\/IEC 17025:2017 7.2.1.7\r\n\nISO\/IEC 17025:2017 7.2.2.1\r\n\nISO\/IEC 17025:2017 7.10.2\r\n\nISO\/IEC 17025:2017 8.7.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 7.3\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)\r\n\nUSDA Administrative Procedures for the PDP 8.2.2\r\n\nWADA International Standard for Laboratories (ISL) 5.3.6\r\n\nWHO Technical Report Series, #986, Annex 2, 16.3\n\n\n16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\n\n\n42 CFR Part 493.1282\r\nASTM E1578-18 E-9-2\r\nE.U. Commission Reg. No. 2073\/2005 Article 9\n\n16.4 The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\n\n\n\n21 CFR Part 606.100 (c)\r\n\n42 CFR Part 493.1282\r\n\nASTM E1578-18 E-9-3\r\n\nCLSI QMS22 2.1.2.1\r\n\nCLSI QMS22 2.2.2.3\r\n\nEPA QA\/G-5 2.2.10\r\n\nWHO Technical Report Series, #986, Annex 2, 17.12\r\n\nWHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.5 The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\n\n\n\n10 CFR Part 30.34 (g)\r\n\n21 CFR Part 112.147\r\n\n21 CFR Part 225.58 (d)\r\n\n21 CFR Part 225.158\r\n\n21 CFR Part 606.100 (c)\r\n\n21 CFR Part 820.100\r\n\n42 CFR Part 493.1282\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nA2LA C211 4.9 and 4.11\r\n\nASTM E1578-18 E-9-4\r\n\nBRC GSFS, Issue 8, 3.4.3\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCLSI QMS22 2.6.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nFDA Hazard Analysis Critical Control Point Principle 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5, IR-5\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\nWADA International Standard for Laboratories (ISL) 5.3.9\r\n\nWHO Technical Report Series, #961, Annex 13, 11.1\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\r\n\nWHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\n\n\n\n21 CFR Part 225.58 (d)\r\n\n21 CFR Part 225.158\r\n\n42 CFR Part 493.1282\r\n\n42 CFR Part 493.1289\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nA2LA C211 4.8 and 4.11\r\n\nASTM E1578-18 E-9-5\r\n\nBRC GSFS, Issue 8, 3.4.3\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.3.4\r\n\nCJIS Security Policy Appendix G.7\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nFDA Hazard Analysis Critical Control Point Principle 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5, AU-6(1)\r\n\nNIST 800-53, Rev. 5, IR-4(1) and IR-5\r\n\nNIST 800-53, Rev. 5, SI-2 and SI-4\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\n\n\n16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\n\n\nASTM E1578-18 E-9-6\n\n16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\n\n\n9 CFR Part 2.35\n\n16.9 The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#8._Resource_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#8._Resource_management<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 2 May 2022, at 22:08.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2,552 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","fe6f7831accf9866e7094abebdb6a6a1_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Maintaining_Laboratory_Workflow_and_Operations rootpage-LII_LIMSpec_Maintaining_Laboratory_Workflow_and_Operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Maintaining Laboratory Workflow and Operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"7._Document_and_records_management\">7. Document and records management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/part-20\" target=\"_blank\">10 CFR Part 20 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.213\u201314<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(e) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.1<\/b> The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.214<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.300\" target=\"_blank\">42 CFR Part 93.300\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1773\" target=\"_blank\">42 CFR Part 493.1773 (c\u2013d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/160.310\" target=\"_blank\">45 CFR Part 160.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 Appendix H5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.2<\/b> The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.3<\/b> The system shall be able to clearly provide the most current version of a document and archive prior versions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.4<\/b> The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.91 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.14<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.5<\/b> The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-12, -14, and -15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.13<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.6<\/b> The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.10\" target=\"_blank\">7 CFR Part 331.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (j-3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.210\" target=\"_blank\">40 CFR Part 262.210\u201312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.7<\/b> The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.8<\/b> The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.9<\/b> The system shall support the addition of accurate cross-references and page numbers to new documents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.10<\/b> The system shall be capable of uniquely identifying documents created in and added to the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>7.11<\/b> The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"8._Resource_management\">8. Resource management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (m)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-3 and -4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.1<\/b> The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.198\" target=\"_blank\">21 CFR Part 820.198<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1233\" target=\"_blank\">42 CFR Part 493.1233<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.10.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.2<\/b> The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123<\/a> 21 CFR Part 123.10]<br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.3<\/b> The system shall allow training sessions and reviews to be scheduled for personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.4<\/b> The system should provide access to relevant training materials to personnel attending training sessions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2\u2013AT-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.5<\/b> The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.6<\/b> The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.7<\/b> The system should be able to produce a training matrix of personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (various parts)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.8<\/b> The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"9._Compliance_management\">9. Compliance management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.1<\/b> The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-2 and AU-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.2<\/b> The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3 and AU-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.3<\/b> The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.4<\/b> The system's audit trail shall document the previous and current value of a modified field.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.5<\/b> The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>9.6<\/b> The system shall prevent a user from copying and pasting the electronic signature of another user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6 and AU-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.7<\/b> The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"10._Instrument_and_equipment_management\">10. Instrument and equipment management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.1<\/b> The system should provide a means for tracking usage of laboratory equipment and instruments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.2<\/b> The system shall provide a means for planning the use of and reserving equipment and instruments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.3<\/b> The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.4<\/b> The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.5<\/b> The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.6<\/b> The system shall be able to group instruments together in specific ways, including by type and laboratory location.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.60\" target=\"_blank\">21 CFR Part 606.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (b-3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2 and MA-2(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.7<\/b> The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.8<\/b> The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.9<\/b> The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.10<\/b> The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.6.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.11<\/b> The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.12<\/b> The system shall support the use of predefined intervals when calculating instrument event dates.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.4 and 5.5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.13<\/b> The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-13<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.14<\/b> The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.63\" target=\"_blank\">21 CFR Part 58.63<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.182\" target=\"_blank\">21 CFR Part 211.182<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1254\" target=\"_blank\">42 CFR Part 493.1254<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20 and -23<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. F-1 and I-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.46<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.15<\/b> The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"11._Batch_and_lot_management\">11. Batch and lot management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.1<\/b> The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.2<\/b> The system shall maintain the links between component parts of a batch and track the batch throughout the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.65\" target=\"_blank\">21 CFR Part 820.65<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.3<\/b> The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>11.4<\/b> The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-15<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>11.5<\/b> The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"12._Scheduled_event_management\">12. Scheduled event management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.6\u20137<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.1<\/b> The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.2<\/b> The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.3<\/b> The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.4<\/b> The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.5<\/b> The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"13._Instrument_data_capture_and_control\">13. Instrument data capture and control<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.1<\/b> The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.2<\/b> The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.3<\/b> The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.4<\/b> The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.5<\/b> The system should be able to accept the results uploaded from an interfaced instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.6<\/b> The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.7<\/b> The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.8<\/b> The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"14._Standard_and_reagent_management\">14. Standard and reagent management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.83\" target=\"_blank\">21 CFR Part 58.83<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>14.1<\/b> The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.3\" target=\"_blank\">7 CFR Part 331.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.3\" target=\"_blank\">9 CFR Part 121.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.3\" target=\"_blank\">42 CFR Part 73.3\u20134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.20<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>14.2<\/b> The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.3<\/b> The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.4<\/b> The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.5<\/b> The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"15._Inventory_management\">15. Inventory management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>15.1<\/b> The system should be capable of accurately tracking the specific quantities of received and consumed test samples and specimens.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.2<\/b> The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (f-6) and (f-10)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.206\" target=\"_blank\">40 CFR Part 262.206<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.10\u201312<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.3<\/b> The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.50\" target=\"_blank\">21 CFR Part 820.50<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.4<\/b> The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.196\" target=\"_blank\">21 CFR Part 211.196<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.90\" target=\"_blank\">21 CFR Part 212.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 Appendix A (I)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.5<\/b> The system should provide a means for accurately recording the receipt, approval, distribution, and disposal of materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.82\" target=\"_blank\">21 CFR Part 211.82 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.142\" target=\"_blank\">21 CFR Part 211.142 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.6<\/b> The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.7<\/b> The system should allow authorized personnel to retire faulty or poor quality materials from use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.8<\/b> The system shall clearly designate a standard or reagent as being disposed or consumed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"16._Investigation_and_quality_management\">16. Investigation and quality management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.1<\/b> The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-2) and (b-2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.2<\/b> The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.81\" target=\"_blank\">21 CFR Part 58.81 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.171\" target=\"_blank\">21 CFR Part 606.171<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1253\" target=\"_blank\">42 CFR Part 493.1253 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual F-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual J-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.3<\/b> The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.4<\/b> The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.5<\/b> The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.147<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.100\" target=\"_blank\">21 CFR Part 820.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.9 and 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 11.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.6<\/b> The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1289\" target=\"_blank\">42 CFR Part 493.1289<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.8 and 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-4(1) and IR-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2 and SI-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.7<\/b> The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.8<\/b> The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.9<\/b> The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173541\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.104 seconds\nReal time usage: 0.111 seconds\nPreprocessor visited node count: 1035\/1000000\nPost\u2010expand include size: 141529\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 20.237 1 -total\n 11.99% 2.426 1 Template:LIMSpec\/Document_management\n 10.55% 2.135 1 Template:LIMSpec\/Resource_management\n 9.87% 1.998 1 Template:LIMSpec\/Instrument_and_equipment_management\n 9.68% 1.958 1 Template:LIMSpec\/Compliance_management\n 9.13% 1.848 1 Template:LIMSpec\/Batch_and_lot_management\n 9.07% 1.836 1 Template:LIMSpec\/Investigation_and_quality_management\n 8.97% 1.815 1 Template:LIMSpec\/Inventory_management\n 8.81% 1.782 1 Template:LIMSpec\/Scheduled_event_management\n 8.72% 1.764 1 Template:LIMSpec\/Instrument_data_capture_and_control\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11181-0!canonical and timestamp 20221202173541 and revision id 47569. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#8._Resource_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#8._Resource_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","fe6f7831accf9866e7094abebdb6a6a1_images":[],"fe6f7831accf9866e7094abebdb6a6a1_timestamp":1670002541,"a764b39a539286107f8212ee654db87b_type":"article","a764b39a539286107f8212ee654db87b_title":"7. Document and records management","a764b39a539286107f8212ee654db87b_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#7._Document_and_records_management","a764b39a539286107f8212ee654db87b_plaintext":"\n\nLII:LIMSpec\/Maintaining Laboratory Workflow and OperationsFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.\n\n7. Document and records management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n7 CFR Part 331 (throughout)\r\n\n9 CFR Part 121 (throughout)\r\n\n10 CFR Part 20 (throughout)\r\n\n21 CFR Part 7 (throughout)\r\n\n21 CFR Part 117 (throughout)\r\n\n21 CFR Part 58 (throughout)\r\n\n21 CFR Part 211 (throughout)\r\n\n21 CFR Part 212 (throughout)\r\n\n21 CFR Part 225 (throughout)\r\n\n21 CFR Part 226 (throughout)\r\n\n21 CFR Part 312 (throughout)\r\n\n21 CFR Part 606 (throughout)\r\n\n21 CFR Part 810 (throughout)\r\n\n21 CFR Part 812 (throughout)\r\n\n21 CFR Part 820 (throughout)\r\n\n29 CFR Part 1910.134 (throughout)\r\n\n29 CFR Part 1910.1030 (throughout)\r\n\n29 CFR Part 1910.1200 (throughout)\r\n\n29 CFR Part 1910.1450 (throughout)\r\n\n40 CFR Part 262.213\u201314\r\n\n42 CFR Part 73 (throughout)\r\n\n42 CFR Part 493.1200\r\n\n42 CFR Part 493.1232\r\n\n42 CFR Part 493.1239\r\n\n42 CFR Part 493.1251\r\n\n42 CFR Part 493.1291 (j)\r\n\n45 CFR Part 164 (throughout)\r\n\n61 FR 38806 (throughout)\r\n\nA2LA C211 4.3\r\n\nA2LA C223 4.13\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\nAAVLD Requirements for an AVMDL (throughout)\r\n\nABFT Accreditation Manual (throughout)\r\n\nASTM E1188-11 3.5.2\r\n\nASTM E1492-11 4.3.3.3 and 4.4.4\r\n\nASTM E1578-18 D-1-1\r\n\nBRC GSFS, Issue 8, 3.1.1\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nBRC GSFS, Issue 8, 5.6.1.1\r\n\nBRC GSFS, Issue 8, 5.6.2.2\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual (throughout)\r\n\nCJIS Security Policy (throughout)\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)\r\n\nEPA 815-R-05-004 (throughout)\r\n\nEPA ERLN Laboratory Requirements (throughout)\r\n\nEPA QA\/G-5 (throughout)\r\n\nE.U. Commission Directive 2003\/94\/EC (throughout)\r\n\nFDA Hazard Analysis Critical Control Point (throughout)\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\nIFS Food 7, Part 2 (throughout)\r\n\nIFS PACsecure 2, Part 2 (throughout)\r\n\nISO 15189:2012 4.3\r\n\nISO 15189:2012 5.5.3\r\n\nISO 15189:2012 5.9.3\r\n\nISO\/IEC 17025:2017 5.3\r\n\nISO\/IEC 17025:2017 5.5\r\n\nISO\/IEC 17025:2017 8.3.2\r\n\nISO\/TS 22002-1:2009 (throughout)\r\n\nISO\/TS 22002-4:2013 (throughout)\r\n\nISO\/TS 22002-6:2016 (throughout)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5 (throughout)\r\n\nOECD GLP Principles 8\r\n\nOSHA 1910.1200(b)(3)\r\n\nOSHA 1910.1450(e) and (h)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\nSQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nUSDA Data and Instrumentation for PDP (throughout)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\nWHO Technical Report Series, #961, Annex 13 (throughout)\r\n\nWHO Technical Report Series, #986, Annex 2 (throughout)\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\n\n\n\n7 CFR Part 331 (throughout)\r\n\n9 CFR Part 121 (throughout)\r\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 7 (throughout)\r\n\n21 CFR Part 58 (throughout)\r\n\n21 CFR Part 117 (throughout)\r\n\n21 CFR Part 211 (throughout)\r\n\n21 CFR Part 212 (throughout)\r\n\n21 CFR Part 225 (throughout)\r\n\n21 CFR Part 226 (throughout)\r\n\n21 CFR Part 312 (throughout)\r\n\n21 CFR Part 606 (throughout)\r\n\n21 CFR Part 810 (throughout)\r\n\n21 CFR Part 812 (throughout)\r\n\n21 CFR Part 820 (throughout)\r\n\n29 CFR Part 1910.134 (c)\r\n\n29 CFR Part 1910.1030 (throughout)\r\n\n29 CFR Part 1910.1200 (e)\r\n\n29 CFR Part 1910.1450 (throughout)\r\n\n40 CFR Part 262.214\r\n\n42 CFR Part 73 (throughout)\r\n\n42 CFR Part 93.300\u20135\r\n\n42 CFR Part 493.1200\r\n\n42 CFR Part 493.1232\r\n\n42 CFR Part 493.1239\r\n\n42 CFR Part 493.1251\r\n\n42 CFR Part 493.1291 (j)\r\n\n42 CFR Part 493.1773 (c\u2013d)\r\n\n45 CFR Part 160.310\r\n\n45 CFR Part 164 (throughout)\r\n\n61 FR 38806 (throughout)\r\n\nA2LA C211 (throughout)\r\n\nA2LA C223 (throughout)\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\nAAVLD Requirements for an AVMDL (throughout)\r\n\nACMG Technical Standards for Clinical Genetics Laboratories (throughout)\r\n\nAIHA-LAP Policies 2022 Appendix H5.8\r\n\nASTM E1188-11 3.5.2\r\n\nASTM E1492-11 4.3.3.3 and 4.4.4\r\n\nASTM E1578-18 D-1-2\r\n\nBRC GSFS, Issue 8, 3.1.2\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nBRC GSFS, Issue 8, 5.6.2.2\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual (throughout)\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)\r\n\nCJIS Security Policy (throughout)\r\n\nCLSI QMS22 (throughout)\r\n\nEPA 815-R-05-004 (throughout)\r\n\nEPA ERLN Laboratory Requirements (throughout)\r\n\nEPA QA\/G-5 (throughout)\r\n\nE.U. Commission Directive 2003\/94\/EC (throughout)\r\n\nFDA Hazard Analysis Critical Control Point (throughout)\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\nIFS Food 7, Part 2 (throughout)\r\n\nIFS PACsecure 2, Part 2 (throughout)\r\n\nISO 15189:2012 (throughout)\r\n\nISO\/IEC 17025:2017 (throughout)\r\n\nISO\/TS 22002-1:2009 (throughout)\r\n\nISO\/TS 22002-4:2013 (throughout)\r\n\nISO\/TS 22002-6:2016 (throughout)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5 (throughout)\r\n\nOECD GLP Principles 8\r\n\nOSHA 1910.1020 (throughout)\r\n\nOSHA 1910.1200(b)(3)\r\n\nOSHA 1910.1450(h)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\nSQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nUSDA Data and Instrumentation for PDP (throughout)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines (throughout)\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3\r\n\nUSDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\nWADA International Standard for Laboratories (ISL) (throughout)\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\r\n\nWHO Technical Report Series, #961, Annex 13 (throughout)\r\n\nWHO Technical Report Series, #986, Annex 2 (throughout)\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.2 The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\n\n\n\n21 CFR Part 1.1154 (c)\r\n\n21 CFR Part 820.40 (a)\r\n\n42 CFR Part 493.1251 (e)\r\n\nA2LA C211 4.3\r\n\nAAVLD Requirements for an AVMDL Sec. 4.3\r\n\nASTM E1578-18 D-1-3\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nEPA 815-R-05-004 Chap. III, Sec. 11\r\n\nEPA ERLN Laboratory Requirements 4.2.4.2\r\n\nEPA QA\/G-5 2.1.9\r\n\nISO 15189:2012 4.3\r\n\nISO 15189:2012 5.5.3\r\n\nISO 15189:2012 5.9.3\r\n\nISO\/IEC 17025:2017 7.5.2\r\n\nISO\/IEC 17025:2017 8.3.2\r\n\nUSDA Administrative Procedures for the PDP 5.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.5\n\n\n7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.\n\n\nASTM E1578-18 D-1-4\n\n7.4 The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1151\r\n\n21 CFR Part 1.1152 (e)\r\n\n21 CFR Part 106.91 (c)\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.315\r\n\n21 CFR Part 111.320\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.160\r\n\n21 CFR Part 212.20 (c)\r\n\n21 CFR Part 212.60 (c)\r\n\n21 CFR Part 226.58 (e)\r\n\n21 CFR Part 820.250 (b)\r\n\n42 CFR Part 493.43 (c)\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nASTM E1578-18 D-1-5\r\n\nBRC GSFS, Issue 8, 5.6.1.1\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.3\r\n\nCodex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\nCodex Alimentarius CXS 234-1999 (throughout)\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 5\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\nIFS Food 7, Part 2, 5.5.2\r\n\nIFS Food 7, Part 2, 5.6.2\r\n\nIFS PACsecure 2, Part 2, 5.5.2\r\n\nIFS PACsecure 2, Part 2, 5.6.2\r\n\nISO\/IEC 17025:2017 6.5\r\n\nISO\/IEC 17025:2017 7.2.1.3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)\r\n\nUSDA Administrative Procedures for the PDP 8.4\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1\r\n\nWHO Technical Report Series, #986, Annex 2, 15.14\n\n\n7.5 The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1151\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.320\r\n\n21 CFR Part 212.20 (c)\r\n\n21 CFR Part 212.70 (b)\r\n\nA2LA C211 5.4.5\r\n\nA2LA C223 5.4\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.4\r\n\nABFT Accreditation Manual Sec. G-12, -14, and -15\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C10\r\n\nACMG Technical Standards for Clinical Genetics Laboratories F7.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4\r\n\nCodex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\nCodex Alimentarius CXS 234-1999 (throughout)\r\n\nEPA QA\/G-5 2.2.4\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\nISO\/IEC 17025:2017 7.2.2.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\nUSDA Administrative Procedures for the PDP 8.4\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6\r\n\nWHO Technical Report Series, #961, Annex 13, 10.1\r\n\nWHO Technical Report Series, #986, Annex 2, 4.11\r\n\nWHO Technical Report Series, #986, Annex 2, 15.13\n\n\n7.6 The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\n\n\n\n7 CFR Part 331.10\r\n\n7 CFR Part 331.15\r\n\n9 CFR Part 2.32\r\n\n9 CFR Part 121.10 \r\n\n9 CFR Part 121.15 \r\n\n10 CFR Part 30.34 (j-3)\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 11.10 (i)\r\n\n21 CFR Part 58.29\r\n\n21 CFR Part 211.25\r\n\n21 CFR Part 225.10\r\n\n21 CFR Part 226.10\r\n\n21 CFR Part 226.40\r\n\n21 CFR Part 820.25\r\n\n29 CFR Part 1910.134 (c)\r\n\n29 CFR Part 1910.1030 (g-2)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n29 CFR Part 1910.1200 (h)\r\n\n29 CFR Part 1910.1450 (f)\r\n\n40 CFR Part 262.207\r\n\n40 CFR Part 262.210\u201312\r\n\n42 CFR Part 73.10\r\n\n42 CFR Part 73.15\r\n\n42 CFR Part 493.43 (c)\r\n\n42 CFR Part 493.1235\r\n\n42 CFR Part 493.1251\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 417.5\r\n\nA2LA C211 5.2\r\n\nA2LA C223 5.2\r\n\nA2LA C223 5.7\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\nAAVLD Requirements for an AVMDL Appendix 1\r\n\nABFT Accreditation Manual Sec. B\r\n\nACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.4\r\n\nAIHA-LAP Policies 2022 (throughout)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASTM E1578-18 C-3-5\r\n\nASTM E1578-18 D-1-6\r\n\nASTM E1578-18 E-1-6\r\n\nBRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nCAP Laboratory Accreditation Manual\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCLSI QMS22 (throughout)\r\n\nE.U. Annex 11-2\r\n\nE.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\nEPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 1\r\n\nEPA QA\/G-5 2.1.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.1\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.1\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nISO 15189:2012 4.1.2.1\r\n\nISO 15189:2012 5.1.6\r\n\nISO 15189:2012 5.1.9\r\n\nISO\/IEC 17025:2017 6.2.2\r\n\nISO\/IEC 17025:2017 6.2.3\r\n\nISO\/IEC 17025:2017 6.2.5\r\n\nISO\/IEC 17025:2017 6.2.6\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nOECD GLP Principles 1.1.2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\n\n\n7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n\n\nASTM E1578-18 D-1-7\n\n7.8 The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\n\n\nAAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5\r\nEPA ERLN Laboratory Requirements 4.10.6\n\n7.9 The system shall support the addition of accurate cross-references and page numbers to new documents.\n\n\nAAVLD Requirements for an AVMDL Sec. 4.3.4\n\n7.10 The system shall be capable of uniquely identifying documents created in and added to the system.\n\n\nAPHL 2019 LIS Project Management Guidebook\r\n\n\n7.11 The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\n\n\n\n8. Resource management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n9 CFR Part 2.32\r\n\n10 CFR Part 20.2103\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 110.10 (c)\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.10\r\n\n29 CFR Part 1910.120\r\n\n29 CFR Part 1910.134 (m)\r\n\n29 CFR Part 1910.1030 (h-1)\r\n\n29 CFR Part 1910.1450 (j)\r\n\n40 CFR Part 262.207\r\n\nA2LA C211 4.13.2.3\r\n\nA2LA C223 5.2\r\n\nA2LA C223 5.7\r\n\nACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nBRC GSFS, Issue 8, 7.3.1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.2.3\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nEPA QA\/G-5 2.1.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.1\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.1\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nNIST 800-53, Rev. 5, AT-3 and -4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOSHA 1910.1020 (throughout)\r\n\nOSHA 1910.1200(b)(3) and (h)\r\n\nOSHA 1910.1450 (throughout)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nUSDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\r\n\nWHO Technical Report Series, #996, Annex 5, 8.1\n\n\n8.1 The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\n\n\n\n21 CFR Part 820.198\r\n\n42 CFR Part 493.1233\r\n\nBRC GSFS, Issue 8, 3.10.1\u20132\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21\r\n\nIFS Food 7, Part 2, 5.8\r\n\nIFS PACsecure 2, Part 2, 5.8\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)\r\n\nWADA International Standard for Laboratories (ISL) 5.3.10\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\n\n\n8.2 The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.\n\n\n\n5 CFR Part 930.301\r\n\n7 CFR Part 331.15\r\n\n9 CFR Part 121.15\r\n\n21 CFR Part 120.12\r\n\nhttps:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123 21 CFR Part 123.10]\r\n\n21 CFR Part 211.25\r\n\n29 CFR Part 1910.1450 (f)\r\n\n42 CFR Part 73.15\r\n\nA2LA C223 5.2\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3\r\n\nASTM E1578-18 E-1-1\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nCJIS Security Policy 5.2.1\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nNIST 800-53, Rev. 5, AT-2 and AT-3\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Sampling Procedures for PDP 6.1.2\u20133\r\n\nWHO Technical Report Series, #986, Annex 2, 10\n\n\n8.3 The system shall allow training sessions and reviews to be scheduled for personnel.\n\n\n\n5 CFR Part 930.301\r\n\n29 CFR Part 1910.1450 (f)\r\n\nABFT Accreditation Manual Sec. B\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7\r\n\nASTM E1578-18 E-1-2\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.4 The system should provide access to relevant training materials to personnel attending training sessions.\n\n\n\n5 CFR Part 930.301\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 110.10 (c)\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.10\r\n\n29 CFR Part 1910.1450 (f)\r\n\n40 CFR Part 262.207\r\n\nA2LA C223 5.2\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5\r\n\nASTM E1578-18 E-1-3\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.2.3\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nEPA QA\/G-5 2.1.8\r\n\nE.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nISO 15189:2012 5.1.9\r\n\nNIST 800-53, Rev. 5, AT-2\u2013AT-4\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e\r\n\nUSDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (e)\r\n\nWHO Technical Report Series, #986, Annex 2, 9.4\r\n\nWHO Technical Report Series, #986, Annex 2, 10\n\n\n8.5 The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\n\n\n\nABFT Accreditation Manual Sec. B\r\n\nASTM E1578-18 E-1-4\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\n\n\n8.6 The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\n\n\n\nASTM E1578-18 E-1-5\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nNIST 800-53, Rev. 5, AT-2 and AT-3\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.7 The system should be able to produce a training matrix of personnel.\n\n\n\n7 CFR Part 331.15\r\n\n9 CFR Part 121.10 \r\n\n9 CFR Part 121.15 \r\n\n21 CFR Part 11.10 (i)\r\n\n21 CFR Part 58.29\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 211.25\r\n\n21 CFR Part 225.10\r\n\n21 CFR Part 226.10\r\n\n21 CFR Part 226.40\r\n\n21 CFR Part 820.25\r\n\n29 CFR Part 1910.1030 (g-2)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n29 CFR Part 1910.1200 (h)\r\n\n29 CFR Part 1910.1450 (e)\r\n\n42 CFR Part 73.10\r\n\n42 CFR Part 73.15\r\n\n42 CFR Part 493.43 (c)\r\n\n42 CFR Part 493.1235\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nA2LA C223 5.2\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\nAAVLD Requirements for an AVMDL Appendix 1\r\n\nABFT Accreditation Manual Sec. B\r\n\nAIHA-LAP Policies 2022 (various parts)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASTM E1578-18 C-3-5\r\n\nASTM E1578-18 D-1-6\r\n\nASTM E1578-18 E-1-6\r\n\nBRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nE.U. Annex 11-2\r\n\nEPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 1\r\n\nEPA QA\/G-5 2.1.8\r\n\nISO 15189:2012 4.1.2.1\r\n\nISO 15189:2012 5.1.6\r\n\nISO 15189:2012 5.1.9\r\n\nISO\/IEC 17025:2017 6.2.2\r\n\nISO\/IEC 17025:2017 6.2.3\r\n\nISO\/IEC 17025:2017 6.2.5\r\n\nISO\/IEC 17025:2017 6.2.6\r\n\nOECD GLP Principles 1.1.2\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\n\n\n8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n\n\n\n9. Compliance management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17 \r\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1251 (d)\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nASTM E1578-18 C-4-7\r\n\nASTM E1578-18 E-2-1\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Annex 11-9\r\n\nE.U. Annex 11-14\r\n\nOECD GLP Principles 8.3.5\r\n\nUSDA Data and Instrumentation for PDP 8.1.3\n\n\n9.1 The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-2\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCJIS Security Policy Appendix G.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Annex 11-9\r\n\nE.U. Annex 11-12.4\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nNIST 800-53, Rev. 5, AC-2(4) and AC-6(9)\r\n\nNIST 800-53, Rev. 5, AU-2 and AU-3\r\n\nNIST 800-53, Rev. 5, CM-5(1)\r\n\nOECD GLP Principles 8.3.5\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n9.2 The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1274\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-3\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCLSI QMS22 2.2.3.2\r\n\nCLSI QMS22 2.4.3\r\n\nE.U. Annex 11-12.4\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nNIST 800-53, Rev. 5, AU-3 and AU-8\r\n\nOECD GLP Principles 8.3.5\r\n\nUSDA Data and Instrumentation for PDP 8.1.4\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.3 The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-4\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nICH GCP 4.9.0 and 4.9.3\r\n\nNIST 800-53, Rev. 5, AU-3\r\n\nOECD GLP Principles 8.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.4 The system's audit trail shall document the previous and current value of a modified field.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1251 (d)\r\n\n45 CFR Part 164.310\r\n\nASTM E1578-18 E-2-5\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nE.U. Annex 11-14\r\n\nOECD GLP Principles 8.3.5\n\n\n9.5 The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\n\n\n21 CFR Part 11.70\r\nE.U. Annex 11-14\n\n9.6 The system shall prevent a user from copying and pasting the electronic signature of another user.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 58.130 (e)\r\n\n42 CFR Part 493.1274 (d)\r\n\nE.U. Annex 11-9\r\n\nNIST 800-53, Rev. 5, AU-6 and AU-12\r\n\nOECD GLP Principles 8.3.5\n\n\n9.7 The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\n\n\n\n10. Instrument and equipment management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-3-1\n\n10.1 The system should provide a means for tracking usage of laboratory equipment and instruments.\n\n\nASTM E1578-18 E-3-2\n\n10.2 The system shall provide a means for planning the use of and reserving equipment and instruments.\n\n\nASTM E1578-18 E-3-3\n\n10.3 The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\n\n\nASTM E1578-18 E-3-4\n\n10.4 The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\n\n\nASTM E1578-18 E-3-5\n\n10.5 The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\n\n\nASTM E1578-18 E-3-6\n\n10.6 The system shall be able to group instruments together in specific ways, including by type and laboratory location.\n\n\n\n21 CFR Part 110.40 (f)\r\n\n21 CFR Part 211.67\u201368\r\n\n21 CFR Part 211.160 (b-4)\r\n\n21 CFR Part 212.30 (b)\r\n\n21 CFR Part 212.60 (e)\r\n\n21 CFR Part 225.30 (b-4)\r\n\n21 CFR Part 606.60\r\n\n21 CFR Part 820.70 (g)\r\n\n21 CFR Part 820.72\r\n\n42 CFR Part 493.1252 (b-3)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.5.2\r\n\nA2LA C223 5.5\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5\r\n\nABFT Accreditation Manual Sec. E-20\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1\r\n\nAIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\nASTM E1578-18 E-3-7\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.6.1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nISO 15189:2012 5.3.1.4\r\n\nISO\/IEC 17025:2017 6.4.7\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nISO\/TS 22002-4:2013, 4.7.1\r\n\nISO\/TS 22002-6:2016, 4.7\r\n\nNIST 800-53, Rev. 5, MA-2 and MA-2(2)\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Data and Instrumentation for PDP 5.2\r\n\nUSDA Data and Instrumentation for PDP 6\r\n\nWADA International Standard for Laboratories (ISL) 5.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 13.5\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\n\n\n\n21 CFR Part 225.30 (b-4)\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5.9\r\n\nASTM E1578-18 E-3-8\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.8 The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\n\n\n\n21 CFR Part 211.160 (b-4)\r\n\nA2LA C211 5.5.7\r\n\nA2LA C223 5.6\r\n\nABFT Accreditation Manual Sec. E-21\r\n\nASTM E1578-18 E-3-9\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nCLSI QMS22 2.1.2.1\r\n\nIFS Food 7, Part 2, 5.4.3\r\n\nIFS PACsecure 2, Part 2, 5.4.3\r\n\nISO 15189:2012 5.3.1.5\r\n\nISO\/IEC 17025:2017 6.4.9\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)\r\n\nWHO Technical Report Series, #986, Annex 2, 13.10\n\n\n10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.\n\n\n\n21 CFR Part 111.117\r\n\n21 CFR Part 820.72 (b-2)\r\n\nASTM E1578-18 E-3-10\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nNIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\n\n\n\n21 CFR Part 820.72 (b-1)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.6.2.1\r\n\nA2LA C223 5.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.6.1\u20132\r\n\nAIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nISO\/IEC 17025:2017 6.5\r\n\nISO\/TS 22002-4:2013, 4.7.1\r\n\nISO\/TS 22002-6:2016, 4.7\r\n\nOECD GLP Principles 4.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.2\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)\r\n\nUSDA Data and Instrumentation for PDP 6.1\n\n\n10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\n\n\nASTM E1578-18 E-3-11\n\n10.12 The system shall support the use of predefined intervals when calculating instrument event dates.\n\n\n\n21 CFR Part 110.40 (f)\r\n\n21 CFR Part 211.105 (b)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.5.4 and 5.5.5\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5.4\u20135\r\n\nASTM E1578-18 E-3-12\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1\r\n\nIFS Food 7, Part 2, 5.4.1\r\n\nIFS PACsecure 2, Part 2, 5.4.1\r\n\nISO 15189:2012 5.3.1.7\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nISO\/IEC 17025:2017 6.4.13\r\n\nNIST 800-53, Rev. 5, CM-8\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\nUSDA Administrative Procedures for the PDP 7.2\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4\r\n\nWHO Technical Report Series, #961, Annex 13, 6.1\n\n\n10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\n\n\nASTM E1578-18 E-3-13\n\n10.14 The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\n\n\n\n10 CFR Part 20.2103\r\n\n21 CFR Part 58.63\r\n\n21 CFR Part 111.117\r\n\n21 CFR Part 211.67\u201368\r\n\n21 CFR Part 211.160 (b-4)\r\n\n21 CFR Part 211.182\r\n\n21 CFR Part 211.194 (d)\r\n\n21 CFR Part 212.30 (b)\r\n\n21 CFR Part 212.60 (e)\r\n\n21 CFR Part 820.70 (g)\r\n\n21 CFR Part 820.72\r\n\n42 CFR Part 493.1254\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 4.13.2.1\r\n\nA2LA C211 5.5.2\r\n\nA2LA C211 5.10.4\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5\r\n\nABFT Accreditation Manual Sec. E-20 and -23\r\n\nABFT Accreditation Manual Sec. F-1 and I-1\r\n\nAIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\nASTM E1578-18 E-3-14\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.2.1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nISO 15189:2012 5.3.1.4\r\n\nISO\/IEC 17025:2017 6.4.4\r\n\nNIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 4.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Data and Instrumentation for PDP 5.4\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c\r\n\nWADA International Standard for Laboratories (ISL) 5.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 15.46\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.15 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\n\n\n\n11. Batch and lot management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 58.105 (a)\r\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nASTM E1578-18 E-4-1\r\n\nEPA ERLN Laboratory Requirements 3.3\r\n\nEPA ERLN Laboratory Requirements 4.10.1\r\n\nOECD GLP Principles 6.2\n\n\n11.1 The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\n\n\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nASTM E1578-18 E-4-2\r\n\nEPA ERLN Laboratory Requirements 4.10.1\n\n\n11.2 The system shall maintain the links between component parts of a batch and track the batch throughout the system.\n\n\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 820.65\r\n\nASTM E1578-18 E-4-3\n\n\n11.3 The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\n\n\nASTM E1578-18 E-4-4\n\n11.4 The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\n\n\nE.U. Annex 11-15\n\n11.5 The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\n\n\n\n12. Scheduled event management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 129.80 (g)\r\nASTM E1578-18 E-5-1\r\nUSDA Sampling Procedures for PDP 5.6\u20137\n\n12.1 The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.\n\n\n21 CFR Part 212.61 (a)\r\n21 CFR Part 211.166 (b)\r\nASTM E1578-18 E-5-2\n\n12.2 The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.\n\n\nASTM E1578-18 E-5-3\n\n12.3 The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\n\n\nASTM E1578-18 E-5-4\n\n12.4 The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).\n\n\nASTM E1578-18 E-5-5\n\n12.5 The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\n\n\n\n13. Instrument data capture and control \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-6-1\n\n13.1 The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\n\n\nASTM E1578-18 E-6-2\n\n13.2 The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\n\n\nASTM E1578-18 E-6-3\n\n13.3 The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\n\n\nASTM E1578-18 E-6-4\n\n13.4 The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\n\n\nASTM E1578-18 E-6-5\n\n13.5 The system should be able to accept the results uploaded from an interfaced instrument.\n\n\nASTM E1578-18 E-6-6\n\n13.6 The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\n\n\nASTM E1578-18 E-6-7\n\n13.7 The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\n\n\nASTM E1578-18 E-6-8\n\n13.8 The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\n\n\n\n14. Standard and reagent management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 58.83\r\n\n29 CFR Part 1910.1200 (g)\r\n\n29 CFR Part 1910.1450 (h)\r\n\n42 CFR Part 493.1252 (c)\r\n\nABFT Accreditation Manual Sec. E-17\r\n\nASTM E1578-18 E-7-1\r\n\nISO 15189:2012 5.3.2.4\u20135\r\n\nOECD GLP Principles 4.4\n\n\n14.1 The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\n\n\n\n7 CFR Part 331.3\r\n\n9 CFR Part 121.3\r\n\n21 CFR Part 312.58 (b)\r\n\n42 CFR Part 73.3\u20134 (c)\r\n\nASTM E1578-18 E-7-2\r\n\nEPA ERLN Laboratory Requirements 4.1.12\r\n\nISO 15189:2012 5.3.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 12.20\n\n\n14.2 The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\n\n\nASTM E1578-18 E-7-3\r\nISO 15189:2012 5.3.2.4\n\n14.3 The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\n\n\nASTM E1578-18 E-7-4\r\nISO 15189:2012 5.3.2.4\n\n14.4 The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\n\n\nASTM E1578-18 E-7-5\r\nISO 15189:2012 5.3.2.4\n\n14.5 The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\n\n\n\n15. Inventory management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-8-1\r\nCAP Laboratory Accreditation Manual\r\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples and specimens.\n\n\n\n21 CFR Part 212.60 (d)\r\n\nASTM E1578-18 E-8-2\r\n\nCLSI QMS22 2.1.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.2 The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\n\n\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.101\r\n\n21 CFR Part 212.60 (d)\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 606.120 (b)\r\n\n29 CFR Part 1910.1030 (g)\r\n\n29 CFR Part 1910.1096 (e-6)\r\n\n29 CFR Part 1910.1200 (f-6) and (f-10)\r\n\n40 CFR Part 262.206\r\n\nASTM E1578-18 E-8-3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOSHA 1910.1200(b)(3) and (f)\r\n\nOSHA 1910.1450(h)\r\n\nWHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41\r\n\nWHO Technical Report Series, #986, Annex 2, 15.10\u201312\n\n\n15.3 The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\n\n\n\n21 CFR Part 117.420\r\n\n21 CFR Part 212.40 (c)\r\n\n21 CFR Part 820.50\r\n\nA2LA C211 4.6\r\n\nASTM E1578-18 E-8-4\r\n\nBRC GSFS, Issue 8, 3.5.1.4\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5\r\n\nIFS Food 7, Part 2, 4.4.1\r\n\nIFS PACsecure 2, Part 2, 4.4.1\r\n\nISO\/TS 22002-1:2009, 9.2\r\n\nISO\/TS 22002-4:2013, 4.6.2\r\n\nISO\/TS 22002-6:2016, 4.6.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.4.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)\r\n\nUSDA Administrative Procedures for the PDP 7.1\r\n\nWHO Technical Report Series, #961, Annex 13, 7.1 and 7.3\r\n\nWHO Technical Report Series, #986, Annex 2, 14.8\n\n\n15.4 The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\n\n\n\n21 CFR Part 211.196\r\n\n21 CFR Part 212.90\r\n\n21 CFR Part 225.110\r\n\n21 CFR Part 606.165\r\n\n29 CFR Part 1910.1450 Appendix A (I)\r\n\nA2LA C211 4.6\r\n\nASTM E1578-18 E-8-5\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5\n\n\n15.5 The system should provide a means for accurately recording the receipt, approval, distribution, and disposal of materials.\n\n\n\n21 CFR Part 211.82 (b)\r\n\n21 CFR Part 211.84 (a)\r\n\n21 CFR Part 211.89\r\n\n21 CFR Part 211.110 (d)\r\n\n21 CFR Part 211.142 (a)\r\n\n21 CFR Part 212.40 (c)\r\n\nASTM E1578-18 E-8-6\r\n\nWHO Technical Report Series, #986, Annex 2, 12.18\n\n\n15.6 The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\n\n\n\n21 CFR Part 211.89\r\n\n21 CFR Part 211.110 (d)\r\n\n42 CFR Part 493.1252 (d)\r\n\nASTM E1578-18 E-8-7\n\n\n15.7 The system should allow authorized personnel to retire faulty or poor quality materials from use.\n\n\n\n21 CFR Part 211.89\r\nASTM E1578-18 E-8-8\n\n\n15.8 The system shall clearly designate a standard or reagent as being disposed or consumed.\n\n\n\n16. Investigation and quality management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 312.62 (b)\r\n21 CFR Part 812.140 (a-3)\n\n16.1 The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\n\n\n\n21 CFR Part 312.57 (a)\r\n\n21 CFR Part 312.62 (a)\r\n\n21 CFR Part 606.165\r\n\n21 CFR Part 812.140 (a-2) and (b-2)\n\n\n16.2 The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\n\n\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 58.81 (a)\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.111\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 211.194\r\n\n21 CFR Part 606.171\r\n\n42 CFR Part 493.1253 (b-2)\r\n\nA2LA C211 5.4\r\n\nABFT Accreditation Manual C-16\r\n\nABFT Accreditation Manual F-2\r\n\nABFT Accreditation Manual J-3\r\n\nASTM E1578-18 E-9-1\r\n\nBRC GSFS, Issue 8, 5.6.2.3\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nCLSI QMS22 2.2.2.2\r\n\nEPA ERLN Laboratory Requirements 3.3\r\n\nEPA QA\/G-5 2.2.4\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\nISO\/IEC 17025:2017 7.2.1.7\r\n\nISO\/IEC 17025:2017 7.2.2.1\r\n\nISO\/IEC 17025:2017 7.10.2\r\n\nISO\/IEC 17025:2017 8.7.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 7.3\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)\r\n\nUSDA Administrative Procedures for the PDP 8.2.2\r\n\nWADA International Standard for Laboratories (ISL) 5.3.6\r\n\nWHO Technical Report Series, #986, Annex 2, 16.3\n\n\n16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\n\n\n42 CFR Part 493.1282\r\nASTM E1578-18 E-9-2\r\nE.U. Commission Reg. No. 2073\/2005 Article 9\n\n16.4 The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\n\n\n\n21 CFR Part 606.100 (c)\r\n\n42 CFR Part 493.1282\r\n\nASTM E1578-18 E-9-3\r\n\nCLSI QMS22 2.1.2.1\r\n\nCLSI QMS22 2.2.2.3\r\n\nEPA QA\/G-5 2.2.10\r\n\nWHO Technical Report Series, #986, Annex 2, 17.12\r\n\nWHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.5 The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\n\n\n\n10 CFR Part 30.34 (g)\r\n\n21 CFR Part 112.147\r\n\n21 CFR Part 225.58 (d)\r\n\n21 CFR Part 225.158\r\n\n21 CFR Part 606.100 (c)\r\n\n21 CFR Part 820.100\r\n\n42 CFR Part 493.1282\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nA2LA C211 4.9 and 4.11\r\n\nASTM E1578-18 E-9-4\r\n\nBRC GSFS, Issue 8, 3.4.3\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCLSI QMS22 2.6.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nFDA Hazard Analysis Critical Control Point Principle 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5, IR-5\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\nWADA International Standard for Laboratories (ISL) 5.3.9\r\n\nWHO Technical Report Series, #961, Annex 13, 11.1\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\r\n\nWHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\n\n\n\n21 CFR Part 225.58 (d)\r\n\n21 CFR Part 225.158\r\n\n42 CFR Part 493.1282\r\n\n42 CFR Part 493.1289\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nA2LA C211 4.8 and 4.11\r\n\nASTM E1578-18 E-9-5\r\n\nBRC GSFS, Issue 8, 3.4.3\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.3.4\r\n\nCJIS Security Policy Appendix G.7\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nFDA Hazard Analysis Critical Control Point Principle 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5, AU-6(1)\r\n\nNIST 800-53, Rev. 5, IR-4(1) and IR-5\r\n\nNIST 800-53, Rev. 5, SI-2 and SI-4\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\n\n\n16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\n\n\nASTM E1578-18 E-9-6\n\n16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\n\n\n9 CFR Part 2.35\n\n16.9 The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#7._Document_and_records_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#7._Document_and_records_management<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 2 May 2022, at 22:08.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2,552 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","a764b39a539286107f8212ee654db87b_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Maintaining_Laboratory_Workflow_and_Operations rootpage-LII_LIMSpec_Maintaining_Laboratory_Workflow_and_Operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Maintaining Laboratory Workflow and Operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"7._Document_and_records_management\">7. Document and records management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/part-20\" target=\"_blank\">10 CFR Part 20 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.213\u201314<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(e) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.1<\/b> The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.214<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.300\" target=\"_blank\">42 CFR Part 93.300\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1773\" target=\"_blank\">42 CFR Part 493.1773 (c\u2013d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/160.310\" target=\"_blank\">45 CFR Part 160.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 Appendix H5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.2<\/b> The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.3<\/b> The system shall be able to clearly provide the most current version of a document and archive prior versions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.4<\/b> The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.91 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.14<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.5<\/b> The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-12, -14, and -15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.13<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.6<\/b> The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.10\" target=\"_blank\">7 CFR Part 331.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (j-3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.210\" target=\"_blank\">40 CFR Part 262.210\u201312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.7<\/b> The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.8<\/b> The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.9<\/b> The system shall support the addition of accurate cross-references and page numbers to new documents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.10<\/b> The system shall be capable of uniquely identifying documents created in and added to the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>7.11<\/b> The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"8._Resource_management\">8. Resource management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (m)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-3 and -4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.1<\/b> The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.198\" target=\"_blank\">21 CFR Part 820.198<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1233\" target=\"_blank\">42 CFR Part 493.1233<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.10.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.2<\/b> The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123<\/a> 21 CFR Part 123.10]<br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.3<\/b> The system shall allow training sessions and reviews to be scheduled for personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.4<\/b> The system should provide access to relevant training materials to personnel attending training sessions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2\u2013AT-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.5<\/b> The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.6<\/b> The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.7<\/b> The system should be able to produce a training matrix of personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (various parts)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.8<\/b> The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"9._Compliance_management\">9. Compliance management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.1<\/b> The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-2 and AU-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.2<\/b> The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3 and AU-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.3<\/b> The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.4<\/b> The system's audit trail shall document the previous and current value of a modified field.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.5<\/b> The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>9.6<\/b> The system shall prevent a user from copying and pasting the electronic signature of another user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6 and AU-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.7<\/b> The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"10._Instrument_and_equipment_management\">10. Instrument and equipment management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.1<\/b> The system should provide a means for tracking usage of laboratory equipment and instruments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.2<\/b> The system shall provide a means for planning the use of and reserving equipment and instruments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.3<\/b> The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.4<\/b> The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.5<\/b> The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.6<\/b> The system shall be able to group instruments together in specific ways, including by type and laboratory location.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.60\" target=\"_blank\">21 CFR Part 606.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (b-3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2 and MA-2(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.7<\/b> The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.8<\/b> The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.9<\/b> The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.10<\/b> The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.6.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.11<\/b> The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.12<\/b> The system shall support the use of predefined intervals when calculating instrument event dates.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.4 and 5.5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.13<\/b> The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-13<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.14<\/b> The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.63\" target=\"_blank\">21 CFR Part 58.63<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.182\" target=\"_blank\">21 CFR Part 211.182<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1254\" target=\"_blank\">42 CFR Part 493.1254<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20 and -23<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. F-1 and I-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.46<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.15<\/b> The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"11._Batch_and_lot_management\">11. Batch and lot management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.1<\/b> The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.2<\/b> The system shall maintain the links between component parts of a batch and track the batch throughout the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.65\" target=\"_blank\">21 CFR Part 820.65<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.3<\/b> The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>11.4<\/b> The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-15<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>11.5<\/b> The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"12._Scheduled_event_management\">12. Scheduled event management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.6\u20137<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.1<\/b> The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.2<\/b> The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.3<\/b> The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.4<\/b> The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.5<\/b> The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"13._Instrument_data_capture_and_control\">13. Instrument data capture and control<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.1<\/b> The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.2<\/b> The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.3<\/b> The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.4<\/b> The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.5<\/b> The system should be able to accept the results uploaded from an interfaced instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.6<\/b> The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.7<\/b> The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.8<\/b> The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"14._Standard_and_reagent_management\">14. Standard and reagent management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.83\" target=\"_blank\">21 CFR Part 58.83<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>14.1<\/b> The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.3\" target=\"_blank\">7 CFR Part 331.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.3\" target=\"_blank\">9 CFR Part 121.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.3\" target=\"_blank\">42 CFR Part 73.3\u20134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.20<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>14.2<\/b> The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.3<\/b> The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.4<\/b> The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.5<\/b> The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"15._Inventory_management\">15. Inventory management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>15.1<\/b> The system should be capable of accurately tracking the specific quantities of received and consumed test samples and specimens.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.2<\/b> The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (f-6) and (f-10)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.206\" target=\"_blank\">40 CFR Part 262.206<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.10\u201312<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.3<\/b> The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.50\" target=\"_blank\">21 CFR Part 820.50<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.4<\/b> The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.196\" target=\"_blank\">21 CFR Part 211.196<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.90\" target=\"_blank\">21 CFR Part 212.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 Appendix A (I)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.5<\/b> The system should provide a means for accurately recording the receipt, approval, distribution, and disposal of materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.82\" target=\"_blank\">21 CFR Part 211.82 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.142\" target=\"_blank\">21 CFR Part 211.142 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.6<\/b> The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.7<\/b> The system should allow authorized personnel to retire faulty or poor quality materials from use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.8<\/b> The system shall clearly designate a standard or reagent as being disposed or consumed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"16._Investigation_and_quality_management\">16. Investigation and quality management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.1<\/b> The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-2) and (b-2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.2<\/b> The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.81\" target=\"_blank\">21 CFR Part 58.81 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.171\" target=\"_blank\">21 CFR Part 606.171<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1253\" target=\"_blank\">42 CFR Part 493.1253 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual F-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual J-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.3<\/b> The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.4<\/b> The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.5<\/b> The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.147<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.100\" target=\"_blank\">21 CFR Part 820.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.9 and 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 11.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.6<\/b> The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1289\" target=\"_blank\">42 CFR Part 493.1289<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.8 and 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-4(1) and IR-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2 and SI-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.7<\/b> The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.8<\/b> The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.9<\/b> The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173541\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.104 seconds\nReal time usage: 0.111 seconds\nPreprocessor visited node count: 1035\/1000000\nPost\u2010expand include size: 141529\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 20.237 1 -total\n 11.99% 2.426 1 Template:LIMSpec\/Document_management\n 10.55% 2.135 1 Template:LIMSpec\/Resource_management\n 9.87% 1.998 1 Template:LIMSpec\/Instrument_and_equipment_management\n 9.68% 1.958 1 Template:LIMSpec\/Compliance_management\n 9.13% 1.848 1 Template:LIMSpec\/Batch_and_lot_management\n 9.07% 1.836 1 Template:LIMSpec\/Investigation_and_quality_management\n 8.97% 1.815 1 Template:LIMSpec\/Inventory_management\n 8.81% 1.782 1 Template:LIMSpec\/Scheduled_event_management\n 8.72% 1.764 1 Template:LIMSpec\/Instrument_data_capture_and_control\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11181-0!canonical and timestamp 20221202173541 and revision id 47569. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#7._Document_and_records_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#7._Document_and_records_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","a764b39a539286107f8212ee654db87b_images":[],"a764b39a539286107f8212ee654db87b_timestamp":1670002541,"671d88f9d757ca0494ddc846debb4903_type":"article","671d88f9d757ca0494ddc846debb4903_title":"6. Reporting","671d88f9d757ca0494ddc846debb4903_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#6._Reporting","671d88f9d757ca0494ddc846debb4903_plaintext":"\n\nLII:LIMSpec\/Primary Laboratory WorkflowFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the core of your typical laboratory workflow, from sample\/specimen receipt and sampling procedures, to analysis, review, and reporting.\n\n1. Sample and experiment registration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 1.1149\r\n\n42 CFR Part 493.1241\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 C-1-1\n\n\n1.1 The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.\n\n\n\n21 CFR Part 58.105 (c)\r\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.101\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 606.120 (b)\r\n\n21 CFR Part 606.121 (c\u2013i)\r\n\n21 CFR Part 606.140 (c)\r\n\n29 CFR Part 1910.1030 (g)\r\n\n29 CFR Part 1910.1096 (e1-6)\r\n\n42 CFR Part 493.1232\r\n\nABFT Accreditation Manual Sec. D\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1492-11 4.1.1.6\r\n\nASTM E1578-18 C-1-2\r\n\nCLSI QMS22 2.2.1.2\r\n\nEPA ERLN Laboratory Requirements 3.2.2\r\n\nEPA QA\/G-5 2.2.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 15\r\nOECD GLP Principles 6.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)\r\n\nUSDA Sampling Procedures for PDP 6.4.1.2.6\r\n\nWHO Technical Report Series, #986, Annex 2, 17.11\n\n\n1.2 The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.\n\n\n45 CFR Part 162.410\r\nCJIS Security Policy 5.6.1\n\n1.3 The system shall provide a means to assign unique identifiers such as a National Provider Identifier (NPI) or Originating Agency Identifier (ORI) to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.\n\n\n42 CFR Part 493.1241\r\nASTM E1578-18 C-1-3\n\n1.4 The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.\n\n\n\n7 CFR Part 91.19\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n40 CFR Part 262.18\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C2.1\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 C-1-4\r\n\nUSDA Sampling Procedures for PDP 6.4.1.1.3\n\n\n1.5 The system should permit unique metadata like lot number, patient number, family identifier, client or patient demographics, sampling point, random selection process used, and industry-specific items (like EPA identification number or U.S. Customs and Border Protection number) to be included during registration.\n\n\nASTM E1578-18 C-1-5\n\n1.6 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.\n\n\nASTM E1578-18 C-1-6\n\n1.7 The system should offer safety information related to a submitted sample upon registration that is relevant to the lab's location and industry.\n\n\nASTM E1578-18 C-1-7\n\n1.8 The system should support the creation and use of predefined metadata templates, as well as ad-hoc, single, and multiple samples.\n\n\n\n7 CFR Part 91.19\r\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 1.1149\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 58.105 (c)\r\n\n21 CFR Part 58.195\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.170\r\n\n21 CFR Part 211.194\r\n\n21 CFR Part 312.57 (d)\r\n\n40 CFR Part 141.33\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1105\r\n\n42 CFR Part 493.1241\r\n\n42 CFR Part 493.1242\r\n\n42 CFR Part 493.1274 (f)\r\n\n42 CFR Part 493.1283\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.2\u20133\r\n\nAAVLD Requirements for an AVMDL Sec. 5.7.1.2\r\n\nABFT Accreditation Manual Sec. D\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C2\r\n\nASTM E1578-18 C-1-8\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 6 and 8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8\r\n\nEPA 815-R-05-004 Supplement 1\r\n\nEPA ERLN Laboratory Requirements 3.2\r\n\nEPA ERLN Laboratory Requirements 4.4.10\u201311\r\n\nEPA ERLN Laboratory Requirements 4.7.1\u20136\r\n\nEPA QA\/G-5 2.2.2 and 2.2.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 11.4\r\n\nISO 15189:2012 5.7.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 6.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13\r\n\nUSDA Sampling Procedures for PDP 5.1\r\n\nWHO Technical Report Series, #986, Annex 2, 17.11 and 17.21\n\n\n1.9 The system shall be able to define the collection details for registered samples or specimens, including container size and type, number of containers, collection date and time, temperature, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.\n\n\n\nASTM E1578-18 C-1-9\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G1.4\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA ERLN Laboratory Requirements 3.2.1\r\n\nEPA ERLN Laboratory Requirements 4.4.5\n\n\n1.10 The system should allow for the addition of observations and descriptions to registered samples in the form of free text.\n\n\nASTM E1578-18 C-1-10\n\n1.11 The system should support the creation of user-definable default sample registration preferences and\/or input screens.\n\n\n\n21 CFR Part 1.1149\r\n\nASTM E1578-18 C-1-11\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7)\r\n\nWADA International Standard for Laboratories (ISL) 5.3.2\n\n\n1.12 The system should allow for the recording of sample delivery details such as deliverer, location, and date and time for a preregistered sample.\n\n\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 58.107 (c)\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1241\r\n\n42 CFR Part 493.1274\r\n\n42 CFR Part 493.1283\r\n\nAAVLD Requirements for an AVMDL Sec. 5.8.2\r\n\nABFT Accreditation Manual D-3\r\n\nASTM E1578-18 C-1-12\r\n\nCAP Laboratory Accreditation Manual\r\n\nEPA ERLN Laboratory Requirements 3.2.2\r\n\nEPA ERLN Laboratory Requirements 4.1.11\r\n\nEPA ERLN Laboratory Requirements 4.4.10\r\n\nEPA QA\/G-5 2.2.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 15\r\n\nISO\/IEC 17025:2017 7.4.2\r\n\nOECD GLP Principles 6.2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.1.11\r\n\nUSDA Sampling Procedures for PDP 6.4.1.2.5\r\n\nWADA International Standard for Laboratories (ISL) 5.3.2\r\n\nWHO Technical Report Series, #986, Annex 2, 17.11\n\n\n1.13 The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 58.107 (d)\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 73.17\r\n\nASTM E1578-18 C-1-13\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA ERLN Laboratory Requirements 4.4.7\r\n\nEPA QA\/G-5 2.2.3\r\n\nOECD GLP Principles 6.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3)\n\n\n1.14 The system shall provide a user-friendly means for tracking and acknowledging the physical reception of submitted sample or specimen material in the laboratory, including date and time of reception.\n\n\n\n21 CFR Part 1.1149\r\n\nASTM E1578-18 C-1-14\r\n\nEPA ERLN Laboratory Requirements 4.4.6\n\n\n1.15 The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.\n\n\n\nACMG Technical Standards for Clinical Genetics Laboratories C3.3\r\n\nAAVLD Requirements for an AVMDL Sec. 5.8.3\r\n\nASTM E1492-11 4.1.1.5\r\n\nASTM E1492-11 4.1.6\r\n\nASTM E1492-11 4.3.3.2\r\n\nASTM E1578-18 C-1-15\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA ERLN Laboratory Requirements 4.4.13\r\n\nEPA ERLN Laboratory Requirements 4.11.8\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.1.3\u20137\r\n\nUSDA Sampling Procedures for PDP 6.4.1.1.9\r\n\nWADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1\n\n\n1.16 The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.\n\n\n\n21 CFR Part 1.1149\r\n\nA2LA C211 5.7\r\n\nASTM E1578-18 C-1-16\r\n\nEPA QA\/G-5 2.2.2 and 2.2.3\n\n\n1.17 The system should provide a means to document sample preparation activities for a given sample.\n\n\n\n7 CFR Part 331.11\r\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.11\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 1.1149\r\n\n21 CFR Part 1.1152 (d)\r\n\n42 CFR Part 73.11\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1274\r\n\nA2LA C223 4.13\r\n\nA2LA C223 5.8\r\n\nABFT Accreditation Manual Sec. D-9\u201310\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1\r\n\nASTM E1492-11 (throughout)\r\n\nASTM E1578-18 C-1-17\r\n\nCLSI QMS22 2.2.3.5\r\n\nEPA 815-R-05-004 Chap. III, Sec. 12\r\n\nEPA 815-R-05-004 Appendix A\r\n\nEPA ERLN Laboratory Requirements 3.2.3\u20135\r\n\nEPA ERLN Laboratory Requirements 4.1.13\r\n\nEPA ERLN Laboratory Requirements 4.4.8\u20139\r\n\nEPA QA\/G-5 2.2.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)\r\n\nWADA International Standard for Laboratories (ISL) (throughout)\n\n\n1.18 The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.\n\n\n7 CFR Part 331.16\r\n9 CFR Part 121.16\r\n42 CFR Part 73.16\n\n1.19 In the case of regulated samples (e.g., select agent or toxin, cannabis, etc.), the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required information.\n\n\nACMG Technical Standards for Clinical Genetics Laboratories G1.1\r\nAPHL 2019 LIS Project Management Guidebook\n\n1.20 The system shall be able to link various records together based on a record's metadata, including sample or specimen identifier, patient number, or family identifier.\n\n\n\n2. Sample management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASTM E1578-18 C-2-1\r\n\nEPA ERLN Laboratory Requirements 4.11.14\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2\n\n\n2.1 The system shall record and maintain the chain of custody for the laboratory's standards and reagents.\n\n\nASTM E1578-18 C-2-2\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.2 The system shall record the current and historical storage location for the laboratory's standards and reagents.\n\n\nASTM E1578-18 C-2-3\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.3 The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.\n\n\nASTM E1578-18 C-2-4\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.4 The system shall require the recording of a standard and reagent's first opening date.\n\n\nASTM E1578-18 C-2-5\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.5 The system shall allow only active standards and reagents to be shown as available for use.\n\n\nASTM E1578-18 C-2-6\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.6 The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.\n\n\nASTM E1578-18 C-2-7\n\n2.7 The system shall allow logically associated samples or specimens to be grouped together based on associated metadata such as type, test method, assigned user, and status.\n\n\nASTM E1578-18 C-2-8\r\nEPA ERLN Laboratory Requirements 3.2\r\nISO\/IEC 17025:2017 7.4.2\n\n2.8 The system should allow for the accurate identification of a physical sample or specimen in the system via barcode or RFID technology.\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 211.84\r\n\n42 CFR Part 73.17\r\n\nASTM E1492-11 4.2.1\r\n\nASTM E1578-18 C-2-9\r\n\nCAP Laboratory Accreditation Manual\n\n\n2.9 The system should provide a means to manually or automatically track sample or specimen inventory amounts and status.\n\n\n\n21 CFR Part 1.1152 (d)\r\n\nA2LA C211 5.4\r\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1\r\nASTM E1578-18 C-2-10\n\n\n2.10 The system shall be able to link test methods and specifications to standards and reagents.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 1.1153 (c)\r\n\n21 CFR Part 111.315\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.166\u20137\r\n\n21 CFR Part 211.194 (e)\r\n\n21 CFR Part 212.40 (c)\r\n\n21 CFR Part 212.61\r\n\n21 CFR Part 212.70 (e)\r\n\n21 CFR Part 225.58\r\n\n21 CFR Part 226.58\r\n\n21 CFR Part 606.65 (c)\r\n\n21 CFR Part 606.151\r\n\nA2LA C223 5.9\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.2\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C10\u201312\r\n\nCAP Laboratory Accreditation Manual\r\n\nASTM E1578-18 C-2-11\r\n\nEPA ERLN Laboratory Requirements 3.1.2.1\r\n\nEPA ERLN Laboratory Requirements 4.3.2\r\n\nEPA ERLN Laboratory Requirements 4.11.3.2\r\n\nEPA QA\/G-5 2.2.5\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)\r\n\nUSDA Administrative Procedures for the PDP 8.5\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\nWADA International Standard for Laboratories (ISL) 5.3.7\r\n\nWHO Technical Report Series, #961, Annex 13, 12.1\r\n\nWHO Technical Report Series, #986, Annex 2, 17.7\r\n\nWHO Technical Report Series, #986, Annex 2, 17.22\u201325\n\n\n2.11 The system shall allow samples, specimens, and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, remediated testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.\n\n\n\n3. Core laboratory testing and experiments \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 111.315\r\n\n21 CFR Part 211.84 (d)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1\r\n\nASTM E1578-18 C-3-1\r\n\nCLSI QMS22 2.2.2.1\r\n\nISO 15189:2012 5.3.2.7\r\n\nWADA International Standard for Laboratories (ISL) 5.2.7\n\n\n3.1 The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.\n\n\n\n21 CFR Part 211.84 (e)\r\n\n42 CFR Part 493.1252 (d)\r\n\nASTM E1578-18 C-3-2\r\n\nWADA International Standard for Laboratories (ISL) 5.2.7\n\n\n3.2 The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.\n\n\n42 CFR Part 493.1252 (d)\r\nASTM E1578-18 C-3-3\n\n3.3 The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.\n\n\nASTM E1578-18 C-3-4\n\n3.4 The system shall be able to check physical, control, and specification limits for an instrument sample.\n\n\nASTM E1578-18 C-3-6\n\n3.5 The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.\n\n\nASTM E1578-18 C-3-7\n\n3.6 The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.\n\n\nASTM E1578-18 C-3-8\n\n3.7 The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.\n\n\nASTM E1578-18 C-3-9\n\n3.8 The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.\n\n\nASTM E1578-18 C-3-10\n\n3.9 The system shall support, at a minimum, the floating point\/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.\n\n\nAIHA-LAP Policies 2022 2A.7.8.2\r\nASTM E1578-18 C-3-11\n\n3.10 The system shall allow users to enter operators such as <, >, +, and - with numeric test results.\n\n\nASTM E1578-18 C-3-12\n\n3.11 The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.\n\n\n42 CFR Part 493.1241\r\nASTM E1578-18 C-3-13\r\nEPA ERLN Laboratory Requirements 4.9.11\n\n3.12 The system should effectively alert users upon entry of out-of-specification test results.\n\n\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 1.1153 (c)\r\n\n21 CFR Part 106.100 (c\u2013f)\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.325\r\n\n21 CFR Part 112.161\r\n\n21 CFR Part 114.100 (a)\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.194\r\n\n21 CFR Part 212.60 (g)\r\n\n21 CFR Part 507.202\r\n\n21 CFR Part 606.160\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G16.1\r\n\nA2LA C223 5.10\nASTM E1578-18 C-3-14\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.1\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCLSI QMS22 2.1.2\r\n\nCLSI QMS22 2.2.2.1\r\n\nEPA ERLN Laboratory Requirements 3.1.2.3\u20134\r\n\nEPA ERLN Laboratory Requirements 3.2\r\n\nEPA ERLN Laboratory Requirements 4.3.4\r\n\nEPA ERLN Laboratory Requirements 4.8.1\u20134\r\n\nEPA ERLN Laboratory Requirements 4.11.16\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section II.4.i\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c\r\n\nIFS Food 7, Part 2, 4.18.3\r\n\nIFS PACsecure 2, Part 2, 4.18.3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.4.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6\r\n\nUSDA Data and Instrumentation for PDP 5.4.2\r\n\nUSDA Data and Instrumentation for PDP 8.1.3\r\n\nWHO Technical Report Series, #986, Annex 2, 15.8\n\n\n3.13 The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.\n\n\nWADA International Standard for Laboratories (ISL) 1.2\n\n3.14 The system shall allow users to link samples, specimens, and tests to a specific accreditation approval status (e.g., World Anti-Doping Agency accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.\n\n\n\n4. Results review and verification \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 211.68 (b)\r\n\n42 CFR Part 493.1241\r\n\nASTM E1578-18 C-4-1\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.1.2\r\n\nEPA ERLN Laboratory Requirements 4.9.11\r\n\nEPA QA\/G-5 2.4.1\r\n\nISO 15189:2012 5.5.1.4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.\n\n\n\nASTM E1578-18 C-4-2\r\n\nCLSI AUTO15 1.2\nEPA ERLN Laboratory Requirements 4.9.2\r\n\nEPA ERLN Laboratory Requirements 4.9.11\r\n\nEPA QA\/G-5 2.4.1\r\n\nISO 15189:2012 5.9.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\n\n4.2 The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.\n\n\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 C-4-3\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCLSI QMS22 2.2.2.2\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nICH GCP 4.9.0 and 4.9.3\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12\n\n\n4.3 The system shall accurately maintain a full audit trail for modified results.\n\n\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 211.68 (b)\r\n\nA2LA C211 5.9.1\r\n\nA2LA C223 4.13\r\n\nABFT Accreditation Manual Sec. E-28\u201329\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G15.1\r\n\nAIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4\u20135\r\n\nASTM E1578-18 C-4-4\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.2.2\r\n\nEPA ERLN Laboratory Requirements 3.2.6\r\n\nEPA ERLN Laboratory Requirements 4.9.2\u20133 and 4.9.11\r\n\nEPA ERLN Laboratory Requirements 4.11.4\r\n\nEPA QA\/G-5 2.2.10\r\n\nEPA QA\/G-5 2.4.1\r\n\nE.U. Annex 11-6\r\n\nIFS Food 7, Part 2, 5.6.4\r\n\nIFS PACsecure 2, Part 2, 5.6.4\r\n\nISO 15189:2012 5.7.1\r\n\nISO\/IEC 17025:2017 7.8.1.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nUSDA Data and Instrumentation for PDP 10\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.1\r\n\nWHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1\n\n\n4.4 The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.\n\n\n\nASTM E1578-18 C-4-5\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nBRC GSFS, Issue 8, 5.6.2.5\r\n\nEPA ERLN Laboratory Requirements 4.9.11\r\n\nEPA QA\/G-5 2.2.10\r\n\nEPA QA\/G-5 2.4.1\r\n\nE.U. Annex 11-6\r\n\nIFS Food 7, Part 2, 5.6.4\r\n\nIFS PACsecure 2, Part 2, 5.6.4\r\n\nISO 15189:2012 5.9.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n4.5 The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.\n\n\n\nASTM E1578-18 C-4-6\r\n\nEPA QA\/G-5 2.2.10\r\n\nEPA QA\/G-5 2.4.1\r\n\nE.U. Annex 11-6\n\n\n4.6 The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.\n\n\nCAP Laboratory Accreditation Manual\r\nCLSI AUTO15 4.0\r\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n4.7 The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.\n\n\n\n 5. Sample, experiment, and study approval and verification \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASTM E1578-18 C-5-1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.3.5\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.9\u201310\r\n\nWADA International Standard for Laboratories (ISL) 5.3.12.1\n\n\n5.1 The system shall accurately record details of a sample or specimen's final disposition.\n\n\n\nAIHA-LAP Policies 2022 2A.7.7.2\r\n\nASTM E1578-18 C-5-2\r\n\nCLSI QMS22 2.2.2.2\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12\n\n\n5.2 The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.\n\n\n21 CFR Part 211.160 (b)\r\nASTM E1578-18 C-5-3\r\nEPA 815-R-05-004 Chap. IV, Sec. 6.1\n\n5.3 The system should provide appropriate functions for specific sample statuses like \"approved\" and \"rejected,\" including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.\n\n\n\n6. Reporting \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 C-6-1\n\n6.1 The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.\n\n\nEPA ERLN Laboratory Requirements 3.4\r\nEPA ERLN Laboratory Requirements 4.1.4\r\nEPA ERLN Laboratory Requirements 4.12\u201315\n\n6.2 The system shall be able to export data in a computer-readable (importable into a relational database) format\u2014such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file\u2014as well as PDF format, for reporting purposes.\n\n\n\n42 CFR Part 493.1291 (g) and (h)\r\n\nACMG Technical Standards for Clinical Genetics Laboratories F7.2\r\n\nASTM E1578-18 C-6-2\r\n\nCLSI QMS22 2.1.2.1\r\n\nEPA ERLN Laboratory Requirements 4.11.4\r\n\nEPA QA\/G-5 2.4.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n6.3 The system shall alert stakeholders in advance to cases when the analyzed sample may be out-of-specification or may not meet expected turnaround time requirements.\n\n\nABFT Accreditation Manual Sec. G-2\n\n6.4 The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., \"less than X mg\/L\") when doing so would provide relevant information to the report recipient.\n\n\n\n7 CFR Part 91.25\r\n\n21 CFR Part 1.1152 (d)\r\n\n40 CFR Part 141.33\r\n\n42 CFR Part 493.1291 (c\u2013e)\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.1\r\n\nAAVLD Requirements for an AVMDL Sec. 5.10.2\u20135\r\n\nAIHA-LAP Policies 2022 2A.7.8.1\r\n\nABFT Accreditation Manual Sec. E-12 and -32\r\n\nASTM E1578-18 C-6-3\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8\r\n\nISO 15189:2012 4.5.2\r\n\nISO 15189:2012 5.8.3\r\n\nISO\/IEC 17025:2017 7.5.1\r\n\nISO\/IEC 17025:2017 7.8.1.1\r\n\nISO\/IEC 17025:2017 7.8.2.1\r\n\nISO\/IEC 17025:2017 7.8.3.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d\r\n\nWHO Technical Report Series, #986, Annex 2, 15.43\n\n\n6.5 The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates.\n\n\n7 CFR Part 91.26\u201327\r\n21 CFR Part 1.1152 (d)\r\nASTM E1578-18 C-6-4\n\n6.6 The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.\n\n\n\nA2LA C211 5.10\r\n\nASTM E1578-18 C-6-5\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCLSI QMS22 2.2.3\r\n\nISO 15189:2012 5.8.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.4\n\n\n6.7 The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, patient results, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.\n\n\n\n7 CFR Part 331.5\r\n\n9 CFR Part 121.5\u20136\r\n\n21 CFR Part 1.1110\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n21 CFR Part 58.185\r\n\n21 CFR Part 312.64\r\n\n21 CFR Part 812.150\r\n\n40 CFR Part 141.31\r\n\n40 CFR Part 141.721\r\n\n40 CFR Part 370 Subpart C\r\n\n40 CFR Part 372 Subpart B\r\n\n40 CFR Part 704\r\n\n40 CFR Part 717 Subpart A\r\n\n40 CFR Part 720.40\r\n\n42 CFR Part 73.5\u20136\r\n\n42 CFR Part 493.43 (d)\r\n\nABFT Accreditation Manual Sec. E-7\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C13.3\r\n\nACMG Technical Standards for Clinical Genetics Laboratories E8\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G17.1\r\n\nASTM E1578-18 C-6-7\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.3.1\r\n\nEPA ERLN Laboratory Requirements 4.12\u201315\r\n\nEPA QA\/G-5 2.3.2\r\n\nIFS Food 7, Part 4, 2.x\r\n\nIFS PACsecure 2, Part 4, 1.x\r\n\nNIST 800-53, Rev. 5, IR-6 and IR-6(1)\r\n\nOECD GLP Principles 9.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.4\n\n\n6.8 The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, analytical worksheets, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.\n\n\n\n7 CFR Part 91.28\r\n\n21 CFR Part 1.1154 (c)\r\n\n21 CFR Part 58 Sec. 58.185 (c)\r\n\nA2LA C211 5.10.9\r\n\nAAVLD Requirements for an AVMDL Sec. 5.10.9\u201310\r\n\nCLSI QMS22 2.2.3.4\r\n\nICH GCP 4.9.3\r\n\nISO\/IEC 17025:2017 7.8.8\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 9.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)\r\n\n\n\n6.9 The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#6._Reporting\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#6._Reporting<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 20 September 2019, at 17:58.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2,200 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","671d88f9d757ca0494ddc846debb4903_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Primary_Laboratory_Workflow rootpage-LII_LIMSpec_Primary_Laboratory_Workflow skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Primary Laboratory Workflow<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the core of your typical laboratory workflow, from sample\/specimen receipt and sampling procedures, to analysis, review, and reporting.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"1._Sample_and_experiment_registration\">1. Sample and experiment registration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.1<\/b> The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.121\" target=\"_blank\">21 CFR Part 606.121 (c\u2013i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.140\" target=\"_blank\">21 CFR Part 606.140 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e1-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 15<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.2<\/b> The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/162.410\" target=\"_blank\">45 CFR Part 162.410<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.3<\/b> The system shall provide a means to assign unique identifiers such as a National Provider Identifier (NPI) or Originating Agency Identifier (ORI) to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.4<\/b> The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.19\" target=\"_blank\">7 CFR Part 91.19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.18\" target=\"_blank\">40 CFR Part 262.18<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.5<\/b> The system should permit unique metadata like lot number, patient number, family identifier, client or patient demographics, sampling point, random selection process used, and industry-specific items (like EPA identification number or U.S. Customs and Border Protection number) to be included during registration.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.6<\/b> The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.7<\/b> The system should offer safety information related to a submitted sample upon registration that is relevant to the lab's location and industry.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.8<\/b> The system should support the creation and use of predefined metadata templates, as well as ad-hoc, single, and multiple samples.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.19\" target=\"_blank\">7 CFR Part 91.19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.195<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.170\" target=\"_blank\">21 CFR Part 211.170<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1105\" target=\"_blank\">42 CFR Part 493.1105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1242\" target=\"_blank\">42 CFR Part 493.1242<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.7.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6 and 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=P1000PUE.txt\" target=\"_blank\">EPA 815-R-05-004 Supplement 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.10\u201311<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.7.1\u20136<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.2 and 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11 and 17.21<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.9<\/b> The system shall be able to define the collection details for registered samples or specimens, including container size and type, number of containers, collection date and time, temperature, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.10<\/b> The system should allow for the addition of observations and descriptions to registered samples in the form of free text.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.11<\/b> The system should support the creation of user-definable default sample registration preferences and\/or input screens.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.12<\/b> The system should allow for the recording of sample delivery details such as deliverer, location, and date and time for a preregistered sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.107\" target=\"_blank\">21 CFR Part 58.107 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.8.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual D-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.13<\/b> The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.107\" target=\"_blank\">21 CFR Part 58.107 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.14<\/b> The system shall provide a user-friendly means for tracking and acknowledging the physical reception of submitted sample or specimen material in the laboratory, including date and time of reception.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.15<\/b> The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1.3\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.16<\/b> The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.2 and 2.2.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.17<\/b> The system should provide a means to document sample preparation activities for a given sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D-9\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Appendix A<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.3\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.8\u20139<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.18<\/b> The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.16\" target=\"_blank\">7 CFR Part 331.16<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.16\" target=\"_blank\">9 CFR Part 121.16<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.16\" target=\"_blank\">42 CFR Part 73.16<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.19<\/b> In the case of regulated samples (e.g., select agent or toxin, cannabis, etc.), the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.20<\/b> The system shall be able to link various records together based on a record's metadata, including sample or specimen identifier, patient number, or family identifier.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"2._Sample_management\">2. Sample management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.1<\/b> The system shall record and maintain the chain of custody for the laboratory's standards and reagents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.2<\/b> The system shall record the current and historical storage location for the laboratory's standards and reagents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.3<\/b> The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.4<\/b> The system shall require the recording of a standard and reagent's first opening date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.5<\/b> The system shall allow only active standards and reagents to be shown as available for use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.6<\/b> The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.7<\/b> The system shall allow logically associated samples or specimens to be grouped together based on associated metadata such as type, test method, assigned user, and status.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.8<\/b> The system should allow for the accurate identification of a physical sample or specimen in the system via barcode or RFID technology.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.9<\/b> The system should provide a means to manually or automatically track sample or specimen inventory amounts and status.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.10<\/b> The system shall be able to link test methods and specifications to standards and reagents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1153 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.65\" target=\"_blank\">21 CFR Part 606.65 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.151\" target=\"_blank\">21 CFR Part 606.151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10\u201312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 12.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.22\u201325<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.11<\/b> The system shall allow samples, specimens, and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, remediated testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"3._Core_laboratory_testing_and_experiments\">3. Core laboratory testing and experiments<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>3.1<\/b> The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>3.2<\/b> The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.3<\/b> The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.4<\/b> The system shall be able to check physical, control, and specification limits for an instrument sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.5<\/b> The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.6<\/b> The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.7<\/b> The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.8<\/b> The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.9<\/b> The system shall support, at a minimum, the floating point\/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.10<\/b> The system shall allow users to enter operators such as <, >, +, and - with numeric test results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.11<\/b> The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-13<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.12<\/b> The system should effectively alert users upon entry of out-of-specification test results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1153 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (c\u2013f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.325<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.161<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.202<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.160\" target=\"_blank\">21 CFR Part 606.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G16.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.10<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.1.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.1\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section II.4.i<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>3.13<\/b> The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 1.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.14<\/b> The system shall allow users to link samples, specimens, and tests to a specific accreditation approval status (e.g., World Anti-Doping Agency accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"4._Results_review_and_verification\">4. Results review and verification<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.1<\/b> The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 1.2<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.2<\/b> The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.3<\/b> The system shall accurately maintain a full audit trail for modified results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-28\u201329<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G15.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.2\u20133 and 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.4<\/b> The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.5<\/b> The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.6<\/b> The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 4.0<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>4.7<\/b> The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span id=\"rdp-ebb-5._Sample,_experiment,_and_study_approval_and_verification\"><\/span><span class=\"mw-headline\" id=\"5._Sample.2C_experiment.2C_and_study_approval_and_verification\">5. Sample, experiment, and study approval and verification<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.9\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.12.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>5.1<\/b> The system shall accurately record details of a sample or specimen's final disposition.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>5.2<\/b> The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>5.3<\/b> The system should provide appropriate functions for specific sample statuses like \"approved\" and \"rejected,\" including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"6._Reporting\">6. Reporting<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.1<\/b> The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.12\u201315<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.2<\/b> The system shall be able to export data in a computer-readable (importable into a relational database) format\u2014such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file\u2014as well as PDF format, for reporting purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (g) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.3<\/b> The system shall alert stakeholders in advance to cases when the analyzed sample may be out-of-specification or may not meet expected turnaround time requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.4<\/b> The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., \"less than X mg\/L\") when doing so would provide relevant information to the report recipient.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.25\" target=\"_blank\">7 CFR Part 91.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (c\u2013e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.10.2\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-12 and -32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.43<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.5<\/b> The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.26\" target=\"_blank\">7 CFR Part 91.26\u201327<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.6<\/b> The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.7<\/b> The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, patient results, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.5\" target=\"_blank\">7 CFR Part 331.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.5\" target=\"_blank\">9 CFR Part 121.5\u20136<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.185\" target=\"_blank\">21 CFR Part 58.185<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.64\" target=\"_blank\">21 CFR Part 312.64<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.150\" target=\"_blank\">21 CFR Part 812.150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.31\" target=\"_blank\">40 CFR Part 141.31<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.721\" target=\"_blank\">40 CFR Part 141.721<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-370\/subpart-C\" target=\"_blank\">40 CFR Part 370 Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-372\/subpart-B\" target=\"_blank\">40 CFR Part 372 Subpart B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\" target=\"_blank\">40 CFR Part 704<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-717\/subpart-A\" target=\"_blank\">40 CFR Part 717 Subpart A<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/720.40\" target=\"_blank\">40 CFR Part 720.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.5\" target=\"_blank\">42 CFR Part 73.5\u20136<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C13.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories E8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G17.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.12\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 4, 2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 4, 1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-6 and IR-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.8<\/b> The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, analytical worksheets, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.28\" target=\"_blank\">7 CFR Part 91.28<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.185\" target=\"_blank\">21 CFR Part 58 Sec. 58.185 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.10.9\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.9<\/b> The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173540\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.057 seconds\nReal time usage: 0.060 seconds\nPreprocessor visited node count: 482\/1000000\nPost\u2010expand include size: 76839\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 11.378 1 -total\n 17.77% 2.022 1 Template:LIMSpec\/Sample_and_experiment_registration\n 15.99% 1.820 1 Template:LIMSpec\/Reporting\n 15.94% 1.813 1 Template:LIMSpec\/Results_review_and_verification\n 15.92% 1.811 1 Template:LIMSpec\/Sample_management\n 15.51% 1.765 1 Template:LIMSpec\/Core_laboratory_testing_and_experiments\n 14.69% 1.671 1 Template:LIMSpec\/Sample,_experiment,_and_study_approval_and_verification\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11179-0!canonical and timestamp 20221202173540 and revision id 36389. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#6._Reporting\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#6._Reporting<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","671d88f9d757ca0494ddc846debb4903_images":[],"671d88f9d757ca0494ddc846debb4903_timestamp":1670002541,"99136bc05337b7583a7395cbd590656a_type":"article","99136bc05337b7583a7395cbd590656a_title":"5. Sample, experiment, and study approval and verification","99136bc05337b7583a7395cbd590656a_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#5._Sample.2C_experiment.2C_and_study_approval_and_verification","99136bc05337b7583a7395cbd590656a_plaintext":"\n\nLII:LIMSpec\/Primary Laboratory WorkflowFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the core of your typical laboratory workflow, from sample\/specimen receipt and sampling procedures, to analysis, review, and reporting.\n\n1. Sample and experiment registration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 1.1149\r\n\n42 CFR Part 493.1241\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 C-1-1\n\n\n1.1 The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.\n\n\n\n21 CFR Part 58.105 (c)\r\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.101\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 606.120 (b)\r\n\n21 CFR Part 606.121 (c\u2013i)\r\n\n21 CFR Part 606.140 (c)\r\n\n29 CFR Part 1910.1030 (g)\r\n\n29 CFR Part 1910.1096 (e1-6)\r\n\n42 CFR Part 493.1232\r\n\nABFT Accreditation Manual Sec. D\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1492-11 4.1.1.6\r\n\nASTM E1578-18 C-1-2\r\n\nCLSI QMS22 2.2.1.2\r\n\nEPA ERLN Laboratory Requirements 3.2.2\r\n\nEPA QA\/G-5 2.2.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 15\r\nOECD GLP Principles 6.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)\r\n\nUSDA Sampling Procedures for PDP 6.4.1.2.6\r\n\nWHO Technical Report Series, #986, Annex 2, 17.11\n\n\n1.2 The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.\n\n\n45 CFR Part 162.410\r\nCJIS Security Policy 5.6.1\n\n1.3 The system shall provide a means to assign unique identifiers such as a National Provider Identifier (NPI) or Originating Agency Identifier (ORI) to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.\n\n\n42 CFR Part 493.1241\r\nASTM E1578-18 C-1-3\n\n1.4 The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.\n\n\n\n7 CFR Part 91.19\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n40 CFR Part 262.18\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C2.1\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 C-1-4\r\n\nUSDA Sampling Procedures for PDP 6.4.1.1.3\n\n\n1.5 The system should permit unique metadata like lot number, patient number, family identifier, client or patient demographics, sampling point, random selection process used, and industry-specific items (like EPA identification number or U.S. Customs and Border Protection number) to be included during registration.\n\n\nASTM E1578-18 C-1-5\n\n1.6 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.\n\n\nASTM E1578-18 C-1-6\n\n1.7 The system should offer safety information related to a submitted sample upon registration that is relevant to the lab's location and industry.\n\n\nASTM E1578-18 C-1-7\n\n1.8 The system should support the creation and use of predefined metadata templates, as well as ad-hoc, single, and multiple samples.\n\n\n\n7 CFR Part 91.19\r\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 1.1149\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 58.105 (c)\r\n\n21 CFR Part 58.195\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.170\r\n\n21 CFR Part 211.194\r\n\n21 CFR Part 312.57 (d)\r\n\n40 CFR Part 141.33\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1105\r\n\n42 CFR Part 493.1241\r\n\n42 CFR Part 493.1242\r\n\n42 CFR Part 493.1274 (f)\r\n\n42 CFR Part 493.1283\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.2\u20133\r\n\nAAVLD Requirements for an AVMDL Sec. 5.7.1.2\r\n\nABFT Accreditation Manual Sec. D\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C2\r\n\nASTM E1578-18 C-1-8\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 6 and 8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8\r\n\nEPA 815-R-05-004 Supplement 1\r\n\nEPA ERLN Laboratory Requirements 3.2\r\n\nEPA ERLN Laboratory Requirements 4.4.10\u201311\r\n\nEPA ERLN Laboratory Requirements 4.7.1\u20136\r\n\nEPA QA\/G-5 2.2.2 and 2.2.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 11.4\r\n\nISO 15189:2012 5.7.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 6.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13\r\n\nUSDA Sampling Procedures for PDP 5.1\r\n\nWHO Technical Report Series, #986, Annex 2, 17.11 and 17.21\n\n\n1.9 The system shall be able to define the collection details for registered samples or specimens, including container size and type, number of containers, collection date and time, temperature, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.\n\n\n\nASTM E1578-18 C-1-9\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G1.4\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA ERLN Laboratory Requirements 3.2.1\r\n\nEPA ERLN Laboratory Requirements 4.4.5\n\n\n1.10 The system should allow for the addition of observations and descriptions to registered samples in the form of free text.\n\n\nASTM E1578-18 C-1-10\n\n1.11 The system should support the creation of user-definable default sample registration preferences and\/or input screens.\n\n\n\n21 CFR Part 1.1149\r\n\nASTM E1578-18 C-1-11\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7)\r\n\nWADA International Standard for Laboratories (ISL) 5.3.2\n\n\n1.12 The system should allow for the recording of sample delivery details such as deliverer, location, and date and time for a preregistered sample.\n\n\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 58.107 (c)\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1241\r\n\n42 CFR Part 493.1274\r\n\n42 CFR Part 493.1283\r\n\nAAVLD Requirements for an AVMDL Sec. 5.8.2\r\n\nABFT Accreditation Manual D-3\r\n\nASTM E1578-18 C-1-12\r\n\nCAP Laboratory Accreditation Manual\r\n\nEPA ERLN Laboratory Requirements 3.2.2\r\n\nEPA ERLN Laboratory Requirements 4.1.11\r\n\nEPA ERLN Laboratory Requirements 4.4.10\r\n\nEPA QA\/G-5 2.2.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 15\r\n\nISO\/IEC 17025:2017 7.4.2\r\n\nOECD GLP Principles 6.2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.1.11\r\n\nUSDA Sampling Procedures for PDP 6.4.1.2.5\r\n\nWADA International Standard for Laboratories (ISL) 5.3.2\r\n\nWHO Technical Report Series, #986, Annex 2, 17.11\n\n\n1.13 The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 58.107 (d)\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 73.17\r\n\nASTM E1578-18 C-1-13\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA ERLN Laboratory Requirements 4.4.7\r\n\nEPA QA\/G-5 2.2.3\r\n\nOECD GLP Principles 6.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3)\n\n\n1.14 The system shall provide a user-friendly means for tracking and acknowledging the physical reception of submitted sample or specimen material in the laboratory, including date and time of reception.\n\n\n\n21 CFR Part 1.1149\r\n\nASTM E1578-18 C-1-14\r\n\nEPA ERLN Laboratory Requirements 4.4.6\n\n\n1.15 The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.\n\n\n\nACMG Technical Standards for Clinical Genetics Laboratories C3.3\r\n\nAAVLD Requirements for an AVMDL Sec. 5.8.3\r\n\nASTM E1492-11 4.1.1.5\r\n\nASTM E1492-11 4.1.6\r\n\nASTM E1492-11 4.3.3.2\r\n\nASTM E1578-18 C-1-15\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA ERLN Laboratory Requirements 4.4.13\r\n\nEPA ERLN Laboratory Requirements 4.11.8\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.1.3\u20137\r\n\nUSDA Sampling Procedures for PDP 6.4.1.1.9\r\n\nWADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1\n\n\n1.16 The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.\n\n\n\n21 CFR Part 1.1149\r\n\nA2LA C211 5.7\r\n\nASTM E1578-18 C-1-16\r\n\nEPA QA\/G-5 2.2.2 and 2.2.3\n\n\n1.17 The system should provide a means to document sample preparation activities for a given sample.\n\n\n\n7 CFR Part 331.11\r\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.11\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 1.1149\r\n\n21 CFR Part 1.1152 (d)\r\n\n42 CFR Part 73.11\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1274\r\n\nA2LA C223 4.13\r\n\nA2LA C223 5.8\r\n\nABFT Accreditation Manual Sec. D-9\u201310\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1\r\n\nASTM E1492-11 (throughout)\r\n\nASTM E1578-18 C-1-17\r\n\nCLSI QMS22 2.2.3.5\r\n\nEPA 815-R-05-004 Chap. III, Sec. 12\r\n\nEPA 815-R-05-004 Appendix A\r\n\nEPA ERLN Laboratory Requirements 3.2.3\u20135\r\n\nEPA ERLN Laboratory Requirements 4.1.13\r\n\nEPA ERLN Laboratory Requirements 4.4.8\u20139\r\n\nEPA QA\/G-5 2.2.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)\r\n\nWADA International Standard for Laboratories (ISL) (throughout)\n\n\n1.18 The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.\n\n\n7 CFR Part 331.16\r\n9 CFR Part 121.16\r\n42 CFR Part 73.16\n\n1.19 In the case of regulated samples (e.g., select agent or toxin, cannabis, etc.), the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required information.\n\n\nACMG Technical Standards for Clinical Genetics Laboratories G1.1\r\nAPHL 2019 LIS Project Management Guidebook\n\n1.20 The system shall be able to link various records together based on a record's metadata, including sample or specimen identifier, patient number, or family identifier.\n\n\n\n2. Sample management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASTM E1578-18 C-2-1\r\n\nEPA ERLN Laboratory Requirements 4.11.14\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2\n\n\n2.1 The system shall record and maintain the chain of custody for the laboratory's standards and reagents.\n\n\nASTM E1578-18 C-2-2\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.2 The system shall record the current and historical storage location for the laboratory's standards and reagents.\n\n\nASTM E1578-18 C-2-3\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.3 The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.\n\n\nASTM E1578-18 C-2-4\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.4 The system shall require the recording of a standard and reagent's first opening date.\n\n\nASTM E1578-18 C-2-5\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.5 The system shall allow only active standards and reagents to be shown as available for use.\n\n\nASTM E1578-18 C-2-6\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.6 The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.\n\n\nASTM E1578-18 C-2-7\n\n2.7 The system shall allow logically associated samples or specimens to be grouped together based on associated metadata such as type, test method, assigned user, and status.\n\n\nASTM E1578-18 C-2-8\r\nEPA ERLN Laboratory Requirements 3.2\r\nISO\/IEC 17025:2017 7.4.2\n\n2.8 The system should allow for the accurate identification of a physical sample or specimen in the system via barcode or RFID technology.\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 211.84\r\n\n42 CFR Part 73.17\r\n\nASTM E1492-11 4.2.1\r\n\nASTM E1578-18 C-2-9\r\n\nCAP Laboratory Accreditation Manual\n\n\n2.9 The system should provide a means to manually or automatically track sample or specimen inventory amounts and status.\n\n\n\n21 CFR Part 1.1152 (d)\r\n\nA2LA C211 5.4\r\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1\r\nASTM E1578-18 C-2-10\n\n\n2.10 The system shall be able to link test methods and specifications to standards and reagents.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 1.1153 (c)\r\n\n21 CFR Part 111.315\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.166\u20137\r\n\n21 CFR Part 211.194 (e)\r\n\n21 CFR Part 212.40 (c)\r\n\n21 CFR Part 212.61\r\n\n21 CFR Part 212.70 (e)\r\n\n21 CFR Part 225.58\r\n\n21 CFR Part 226.58\r\n\n21 CFR Part 606.65 (c)\r\n\n21 CFR Part 606.151\r\n\nA2LA C223 5.9\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.2\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C10\u201312\r\n\nCAP Laboratory Accreditation Manual\r\n\nASTM E1578-18 C-2-11\r\n\nEPA ERLN Laboratory Requirements 3.1.2.1\r\n\nEPA ERLN Laboratory Requirements 4.3.2\r\n\nEPA ERLN Laboratory Requirements 4.11.3.2\r\n\nEPA QA\/G-5 2.2.5\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)\r\n\nUSDA Administrative Procedures for the PDP 8.5\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\nWADA International Standard for Laboratories (ISL) 5.3.7\r\n\nWHO Technical Report Series, #961, Annex 13, 12.1\r\n\nWHO Technical Report Series, #986, Annex 2, 17.7\r\n\nWHO Technical Report Series, #986, Annex 2, 17.22\u201325\n\n\n2.11 The system shall allow samples, specimens, and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, remediated testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.\n\n\n\n3. Core laboratory testing and experiments \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 111.315\r\n\n21 CFR Part 211.84 (d)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1\r\n\nASTM E1578-18 C-3-1\r\n\nCLSI QMS22 2.2.2.1\r\n\nISO 15189:2012 5.3.2.7\r\n\nWADA International Standard for Laboratories (ISL) 5.2.7\n\n\n3.1 The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.\n\n\n\n21 CFR Part 211.84 (e)\r\n\n42 CFR Part 493.1252 (d)\r\n\nASTM E1578-18 C-3-2\r\n\nWADA International Standard for Laboratories (ISL) 5.2.7\n\n\n3.2 The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.\n\n\n42 CFR Part 493.1252 (d)\r\nASTM E1578-18 C-3-3\n\n3.3 The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.\n\n\nASTM E1578-18 C-3-4\n\n3.4 The system shall be able to check physical, control, and specification limits for an instrument sample.\n\n\nASTM E1578-18 C-3-6\n\n3.5 The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.\n\n\nASTM E1578-18 C-3-7\n\n3.6 The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.\n\n\nASTM E1578-18 C-3-8\n\n3.7 The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.\n\n\nASTM E1578-18 C-3-9\n\n3.8 The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.\n\n\nASTM E1578-18 C-3-10\n\n3.9 The system shall support, at a minimum, the floating point\/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.\n\n\nAIHA-LAP Policies 2022 2A.7.8.2\r\nASTM E1578-18 C-3-11\n\n3.10 The system shall allow users to enter operators such as <, >, +, and - with numeric test results.\n\n\nASTM E1578-18 C-3-12\n\n3.11 The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.\n\n\n42 CFR Part 493.1241\r\nASTM E1578-18 C-3-13\r\nEPA ERLN Laboratory Requirements 4.9.11\n\n3.12 The system should effectively alert users upon entry of out-of-specification test results.\n\n\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 1.1153 (c)\r\n\n21 CFR Part 106.100 (c\u2013f)\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.325\r\n\n21 CFR Part 112.161\r\n\n21 CFR Part 114.100 (a)\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.194\r\n\n21 CFR Part 212.60 (g)\r\n\n21 CFR Part 507.202\r\n\n21 CFR Part 606.160\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G16.1\r\n\nA2LA C223 5.10\nASTM E1578-18 C-3-14\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.1\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCLSI QMS22 2.1.2\r\n\nCLSI QMS22 2.2.2.1\r\n\nEPA ERLN Laboratory Requirements 3.1.2.3\u20134\r\n\nEPA ERLN Laboratory Requirements 3.2\r\n\nEPA ERLN Laboratory Requirements 4.3.4\r\n\nEPA ERLN Laboratory Requirements 4.8.1\u20134\r\n\nEPA ERLN Laboratory Requirements 4.11.16\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section II.4.i\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c\r\n\nIFS Food 7, Part 2, 4.18.3\r\n\nIFS PACsecure 2, Part 2, 4.18.3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.4.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6\r\n\nUSDA Data and Instrumentation for PDP 5.4.2\r\n\nUSDA Data and Instrumentation for PDP 8.1.3\r\n\nWHO Technical Report Series, #986, Annex 2, 15.8\n\n\n3.13 The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.\n\n\nWADA International Standard for Laboratories (ISL) 1.2\n\n3.14 The system shall allow users to link samples, specimens, and tests to a specific accreditation approval status (e.g., World Anti-Doping Agency accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.\n\n\n\n4. Results review and verification \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 211.68 (b)\r\n\n42 CFR Part 493.1241\r\n\nASTM E1578-18 C-4-1\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.1.2\r\n\nEPA ERLN Laboratory Requirements 4.9.11\r\n\nEPA QA\/G-5 2.4.1\r\n\nISO 15189:2012 5.5.1.4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.\n\n\n\nASTM E1578-18 C-4-2\r\n\nCLSI AUTO15 1.2\nEPA ERLN Laboratory Requirements 4.9.2\r\n\nEPA ERLN Laboratory Requirements 4.9.11\r\n\nEPA QA\/G-5 2.4.1\r\n\nISO 15189:2012 5.9.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\n\n4.2 The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.\n\n\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 C-4-3\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCLSI QMS22 2.2.2.2\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nICH GCP 4.9.0 and 4.9.3\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12\n\n\n4.3 The system shall accurately maintain a full audit trail for modified results.\n\n\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 211.68 (b)\r\n\nA2LA C211 5.9.1\r\n\nA2LA C223 4.13\r\n\nABFT Accreditation Manual Sec. E-28\u201329\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G15.1\r\n\nAIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4\u20135\r\n\nASTM E1578-18 C-4-4\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.2.2\r\n\nEPA ERLN Laboratory Requirements 3.2.6\r\n\nEPA ERLN Laboratory Requirements 4.9.2\u20133 and 4.9.11\r\n\nEPA ERLN Laboratory Requirements 4.11.4\r\n\nEPA QA\/G-5 2.2.10\r\n\nEPA QA\/G-5 2.4.1\r\n\nE.U. Annex 11-6\r\n\nIFS Food 7, Part 2, 5.6.4\r\n\nIFS PACsecure 2, Part 2, 5.6.4\r\n\nISO 15189:2012 5.7.1\r\n\nISO\/IEC 17025:2017 7.8.1.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nUSDA Data and Instrumentation for PDP 10\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.1\r\n\nWHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1\n\n\n4.4 The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.\n\n\n\nASTM E1578-18 C-4-5\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nBRC GSFS, Issue 8, 5.6.2.5\r\n\nEPA ERLN Laboratory Requirements 4.9.11\r\n\nEPA QA\/G-5 2.2.10\r\n\nEPA QA\/G-5 2.4.1\r\n\nE.U. Annex 11-6\r\n\nIFS Food 7, Part 2, 5.6.4\r\n\nIFS PACsecure 2, Part 2, 5.6.4\r\n\nISO 15189:2012 5.9.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n4.5 The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.\n\n\n\nASTM E1578-18 C-4-6\r\n\nEPA QA\/G-5 2.2.10\r\n\nEPA QA\/G-5 2.4.1\r\n\nE.U. Annex 11-6\n\n\n4.6 The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.\n\n\nCAP Laboratory Accreditation Manual\r\nCLSI AUTO15 4.0\r\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n4.7 The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.\n\n\n\n 5. Sample, experiment, and study approval and verification \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASTM E1578-18 C-5-1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.3.5\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.9\u201310\r\n\nWADA International Standard for Laboratories (ISL) 5.3.12.1\n\n\n5.1 The system shall accurately record details of a sample or specimen's final disposition.\n\n\n\nAIHA-LAP Policies 2022 2A.7.7.2\r\n\nASTM E1578-18 C-5-2\r\n\nCLSI QMS22 2.2.2.2\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12\n\n\n5.2 The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.\n\n\n21 CFR Part 211.160 (b)\r\nASTM E1578-18 C-5-3\r\nEPA 815-R-05-004 Chap. IV, Sec. 6.1\n\n5.3 The system should provide appropriate functions for specific sample statuses like \"approved\" and \"rejected,\" including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.\n\n\n\n6. Reporting \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 C-6-1\n\n6.1 The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.\n\n\nEPA ERLN Laboratory Requirements 3.4\r\nEPA ERLN Laboratory Requirements 4.1.4\r\nEPA ERLN Laboratory Requirements 4.12\u201315\n\n6.2 The system shall be able to export data in a computer-readable (importable into a relational database) format\u2014such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file\u2014as well as PDF format, for reporting purposes.\n\n\n\n42 CFR Part 493.1291 (g) and (h)\r\n\nACMG Technical Standards for Clinical Genetics Laboratories F7.2\r\n\nASTM E1578-18 C-6-2\r\n\nCLSI QMS22 2.1.2.1\r\n\nEPA ERLN Laboratory Requirements 4.11.4\r\n\nEPA QA\/G-5 2.4.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n6.3 The system shall alert stakeholders in advance to cases when the analyzed sample may be out-of-specification or may not meet expected turnaround time requirements.\n\n\nABFT Accreditation Manual Sec. G-2\n\n6.4 The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., \"less than X mg\/L\") when doing so would provide relevant information to the report recipient.\n\n\n\n7 CFR Part 91.25\r\n\n21 CFR Part 1.1152 (d)\r\n\n40 CFR Part 141.33\r\n\n42 CFR Part 493.1291 (c\u2013e)\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.1\r\n\nAAVLD Requirements for an AVMDL Sec. 5.10.2\u20135\r\n\nAIHA-LAP Policies 2022 2A.7.8.1\r\n\nABFT Accreditation Manual Sec. E-12 and -32\r\n\nASTM E1578-18 C-6-3\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8\r\n\nISO 15189:2012 4.5.2\r\n\nISO 15189:2012 5.8.3\r\n\nISO\/IEC 17025:2017 7.5.1\r\n\nISO\/IEC 17025:2017 7.8.1.1\r\n\nISO\/IEC 17025:2017 7.8.2.1\r\n\nISO\/IEC 17025:2017 7.8.3.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d\r\n\nWHO Technical Report Series, #986, Annex 2, 15.43\n\n\n6.5 The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates.\n\n\n7 CFR Part 91.26\u201327\r\n21 CFR Part 1.1152 (d)\r\nASTM E1578-18 C-6-4\n\n6.6 The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.\n\n\n\nA2LA C211 5.10\r\n\nASTM E1578-18 C-6-5\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCLSI QMS22 2.2.3\r\n\nISO 15189:2012 5.8.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.4\n\n\n6.7 The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, patient results, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.\n\n\n\n7 CFR Part 331.5\r\n\n9 CFR Part 121.5\u20136\r\n\n21 CFR Part 1.1110\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n21 CFR Part 58.185\r\n\n21 CFR Part 312.64\r\n\n21 CFR Part 812.150\r\n\n40 CFR Part 141.31\r\n\n40 CFR Part 141.721\r\n\n40 CFR Part 370 Subpart C\r\n\n40 CFR Part 372 Subpart B\r\n\n40 CFR Part 704\r\n\n40 CFR Part 717 Subpart A\r\n\n40 CFR Part 720.40\r\n\n42 CFR Part 73.5\u20136\r\n\n42 CFR Part 493.43 (d)\r\n\nABFT Accreditation Manual Sec. E-7\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C13.3\r\n\nACMG Technical Standards for Clinical Genetics Laboratories E8\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G17.1\r\n\nASTM E1578-18 C-6-7\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.3.1\r\n\nEPA ERLN Laboratory Requirements 4.12\u201315\r\n\nEPA QA\/G-5 2.3.2\r\n\nIFS Food 7, Part 4, 2.x\r\n\nIFS PACsecure 2, Part 4, 1.x\r\n\nNIST 800-53, Rev. 5, IR-6 and IR-6(1)\r\n\nOECD GLP Principles 9.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.4\n\n\n6.8 The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, analytical worksheets, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.\n\n\n\n7 CFR Part 91.28\r\n\n21 CFR Part 1.1154 (c)\r\n\n21 CFR Part 58 Sec. 58.185 (c)\r\n\nA2LA C211 5.10.9\r\n\nAAVLD Requirements for an AVMDL Sec. 5.10.9\u201310\r\n\nCLSI QMS22 2.2.3.4\r\n\nICH GCP 4.9.3\r\n\nISO\/IEC 17025:2017 7.8.8\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 9.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)\r\n\n\n\n6.9 The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#5._Sample.2C_experiment.2C_and_study_approval_and_verification\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#5._Sample.2C_experiment.2C_and_study_approval_and_verification<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 20 September 2019, at 17:58.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2,200 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","99136bc05337b7583a7395cbd590656a_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Primary_Laboratory_Workflow rootpage-LII_LIMSpec_Primary_Laboratory_Workflow skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Primary Laboratory Workflow<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the core of your typical laboratory workflow, from sample\/specimen receipt and sampling procedures, to analysis, review, and reporting.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"1._Sample_and_experiment_registration\">1. Sample and experiment registration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.1<\/b> The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.121\" target=\"_blank\">21 CFR Part 606.121 (c\u2013i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.140\" target=\"_blank\">21 CFR Part 606.140 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e1-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 15<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.2<\/b> The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/162.410\" target=\"_blank\">45 CFR Part 162.410<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.3<\/b> The system shall provide a means to assign unique identifiers such as a National Provider Identifier (NPI) or Originating Agency Identifier (ORI) to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.4<\/b> The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.19\" target=\"_blank\">7 CFR Part 91.19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.18\" target=\"_blank\">40 CFR Part 262.18<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.5<\/b> The system should permit unique metadata like lot number, patient number, family identifier, client or patient demographics, sampling point, random selection process used, and industry-specific items (like EPA identification number or U.S. Customs and Border Protection number) to be included during registration.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.6<\/b> The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.7<\/b> The system should offer safety information related to a submitted sample upon registration that is relevant to the lab's location and industry.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.8<\/b> The system should support the creation and use of predefined metadata templates, as well as ad-hoc, single, and multiple samples.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.19\" target=\"_blank\">7 CFR Part 91.19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.195<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.170\" target=\"_blank\">21 CFR Part 211.170<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1105\" target=\"_blank\">42 CFR Part 493.1105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1242\" target=\"_blank\">42 CFR Part 493.1242<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.7.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6 and 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=P1000PUE.txt\" target=\"_blank\">EPA 815-R-05-004 Supplement 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.10\u201311<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.7.1\u20136<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.2 and 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11 and 17.21<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.9<\/b> The system shall be able to define the collection details for registered samples or specimens, including container size and type, number of containers, collection date and time, temperature, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.10<\/b> The system should allow for the addition of observations and descriptions to registered samples in the form of free text.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.11<\/b> The system should support the creation of user-definable default sample registration preferences and\/or input screens.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.12<\/b> The system should allow for the recording of sample delivery details such as deliverer, location, and date and time for a preregistered sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.107\" target=\"_blank\">21 CFR Part 58.107 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.8.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual D-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.13<\/b> The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.107\" target=\"_blank\">21 CFR Part 58.107 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.14<\/b> The system shall provide a user-friendly means for tracking and acknowledging the physical reception of submitted sample or specimen material in the laboratory, including date and time of reception.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.15<\/b> The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1.3\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.16<\/b> The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.2 and 2.2.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.17<\/b> The system should provide a means to document sample preparation activities for a given sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D-9\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Appendix A<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.3\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.8\u20139<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.18<\/b> The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.16\" target=\"_blank\">7 CFR Part 331.16<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.16\" target=\"_blank\">9 CFR Part 121.16<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.16\" target=\"_blank\">42 CFR Part 73.16<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.19<\/b> In the case of regulated samples (e.g., select agent or toxin, cannabis, etc.), the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.20<\/b> The system shall be able to link various records together based on a record's metadata, including sample or specimen identifier, patient number, or family identifier.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"2._Sample_management\">2. Sample management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.1<\/b> The system shall record and maintain the chain of custody for the laboratory's standards and reagents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.2<\/b> The system shall record the current and historical storage location for the laboratory's standards and reagents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.3<\/b> The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.4<\/b> The system shall require the recording of a standard and reagent's first opening date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.5<\/b> The system shall allow only active standards and reagents to be shown as available for use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.6<\/b> The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.7<\/b> The system shall allow logically associated samples or specimens to be grouped together based on associated metadata such as type, test method, assigned user, and status.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.8<\/b> The system should allow for the accurate identification of a physical sample or specimen in the system via barcode or RFID technology.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.9<\/b> The system should provide a means to manually or automatically track sample or specimen inventory amounts and status.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.10<\/b> The system shall be able to link test methods and specifications to standards and reagents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1153 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.65\" target=\"_blank\">21 CFR Part 606.65 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.151\" target=\"_blank\">21 CFR Part 606.151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10\u201312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 12.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.22\u201325<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.11<\/b> The system shall allow samples, specimens, and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, remediated testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"3._Core_laboratory_testing_and_experiments\">3. Core laboratory testing and experiments<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>3.1<\/b> The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>3.2<\/b> The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.3<\/b> The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.4<\/b> The system shall be able to check physical, control, and specification limits for an instrument sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.5<\/b> The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.6<\/b> The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.7<\/b> The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.8<\/b> The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.9<\/b> The system shall support, at a minimum, the floating point\/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.10<\/b> The system shall allow users to enter operators such as <, >, +, and - with numeric test results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.11<\/b> The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-13<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.12<\/b> The system should effectively alert users upon entry of out-of-specification test results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1153 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (c\u2013f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.325<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.161<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.202<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.160\" target=\"_blank\">21 CFR Part 606.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G16.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.10<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.1.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.1\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section II.4.i<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>3.13<\/b> The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 1.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.14<\/b> The system shall allow users to link samples, specimens, and tests to a specific accreditation approval status (e.g., World Anti-Doping Agency accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"4._Results_review_and_verification\">4. Results review and verification<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.1<\/b> The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 1.2<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.2<\/b> The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.3<\/b> The system shall accurately maintain a full audit trail for modified results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-28\u201329<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G15.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.2\u20133 and 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.4<\/b> The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.5<\/b> The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.6<\/b> The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 4.0<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>4.7<\/b> The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span id=\"rdp-ebb-5._Sample,_experiment,_and_study_approval_and_verification\"><\/span><span class=\"mw-headline\" id=\"5._Sample.2C_experiment.2C_and_study_approval_and_verification\">5. Sample, experiment, and study approval and verification<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.9\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.12.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>5.1<\/b> The system shall accurately record details of a sample or specimen's final disposition.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>5.2<\/b> The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>5.3<\/b> The system should provide appropriate functions for specific sample statuses like \"approved\" and \"rejected,\" including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"6._Reporting\">6. Reporting<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.1<\/b> The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.12\u201315<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.2<\/b> The system shall be able to export data in a computer-readable (importable into a relational database) format\u2014such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file\u2014as well as PDF format, for reporting purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (g) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.3<\/b> The system shall alert stakeholders in advance to cases when the analyzed sample may be out-of-specification or may not meet expected turnaround time requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.4<\/b> The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., \"less than X mg\/L\") when doing so would provide relevant information to the report recipient.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.25\" target=\"_blank\">7 CFR Part 91.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (c\u2013e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.10.2\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-12 and -32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.43<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.5<\/b> The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.26\" target=\"_blank\">7 CFR Part 91.26\u201327<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.6<\/b> The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.7<\/b> The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, patient results, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.5\" target=\"_blank\">7 CFR Part 331.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.5\" target=\"_blank\">9 CFR Part 121.5\u20136<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.185\" target=\"_blank\">21 CFR Part 58.185<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.64\" target=\"_blank\">21 CFR Part 312.64<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.150\" target=\"_blank\">21 CFR Part 812.150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.31\" target=\"_blank\">40 CFR Part 141.31<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.721\" target=\"_blank\">40 CFR Part 141.721<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-370\/subpart-C\" target=\"_blank\">40 CFR Part 370 Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-372\/subpart-B\" target=\"_blank\">40 CFR Part 372 Subpart B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\" target=\"_blank\">40 CFR Part 704<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-717\/subpart-A\" target=\"_blank\">40 CFR Part 717 Subpart A<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/720.40\" target=\"_blank\">40 CFR Part 720.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.5\" target=\"_blank\">42 CFR Part 73.5\u20136<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C13.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories E8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G17.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.12\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 4, 2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 4, 1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-6 and IR-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.8<\/b> The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, analytical worksheets, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.28\" target=\"_blank\">7 CFR Part 91.28<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.185\" target=\"_blank\">21 CFR Part 58 Sec. 58.185 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.10.9\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.9<\/b> The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173540\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.057 seconds\nReal time usage: 0.060 seconds\nPreprocessor visited node count: 482\/1000000\nPost\u2010expand include size: 76839\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 11.378 1 -total\n 17.77% 2.022 1 Template:LIMSpec\/Sample_and_experiment_registration\n 15.99% 1.820 1 Template:LIMSpec\/Reporting\n 15.94% 1.813 1 Template:LIMSpec\/Results_review_and_verification\n 15.92% 1.811 1 Template:LIMSpec\/Sample_management\n 15.51% 1.765 1 Template:LIMSpec\/Core_laboratory_testing_and_experiments\n 14.69% 1.671 1 Template:LIMSpec\/Sample,_experiment,_and_study_approval_and_verification\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11179-0!canonical and timestamp 20221202173540 and revision id 36389. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#5._Sample.2C_experiment.2C_and_study_approval_and_verification\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#5._Sample.2C_experiment.2C_and_study_approval_and_verification<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","99136bc05337b7583a7395cbd590656a_images":[],"99136bc05337b7583a7395cbd590656a_timestamp":1670002541,"0275d5f4b1bd7bd8c861ef8f0795dfb6_type":"article","0275d5f4b1bd7bd8c861ef8f0795dfb6_title":"4. Results review and verification","0275d5f4b1bd7bd8c861ef8f0795dfb6_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#4._Results_review_and_verification","0275d5f4b1bd7bd8c861ef8f0795dfb6_plaintext":"\n\nLII:LIMSpec\/Primary Laboratory WorkflowFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the core of your typical laboratory workflow, from sample\/specimen receipt and sampling procedures, to analysis, review, and reporting.\n\n1. Sample and experiment registration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 1.1149\r\n\n42 CFR Part 493.1241\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 C-1-1\n\n\n1.1 The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.\n\n\n\n21 CFR Part 58.105 (c)\r\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.101\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 606.120 (b)\r\n\n21 CFR Part 606.121 (c\u2013i)\r\n\n21 CFR Part 606.140 (c)\r\n\n29 CFR Part 1910.1030 (g)\r\n\n29 CFR Part 1910.1096 (e1-6)\r\n\n42 CFR Part 493.1232\r\n\nABFT Accreditation Manual Sec. D\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1492-11 4.1.1.6\r\n\nASTM E1578-18 C-1-2\r\n\nCLSI QMS22 2.2.1.2\r\n\nEPA ERLN Laboratory Requirements 3.2.2\r\n\nEPA QA\/G-5 2.2.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 15\r\nOECD GLP Principles 6.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)\r\n\nUSDA Sampling Procedures for PDP 6.4.1.2.6\r\n\nWHO Technical Report Series, #986, Annex 2, 17.11\n\n\n1.2 The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.\n\n\n45 CFR Part 162.410\r\nCJIS Security Policy 5.6.1\n\n1.3 The system shall provide a means to assign unique identifiers such as a National Provider Identifier (NPI) or Originating Agency Identifier (ORI) to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.\n\n\n42 CFR Part 493.1241\r\nASTM E1578-18 C-1-3\n\n1.4 The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.\n\n\n\n7 CFR Part 91.19\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n40 CFR Part 262.18\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C2.1\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 C-1-4\r\n\nUSDA Sampling Procedures for PDP 6.4.1.1.3\n\n\n1.5 The system should permit unique metadata like lot number, patient number, family identifier, client or patient demographics, sampling point, random selection process used, and industry-specific items (like EPA identification number or U.S. Customs and Border Protection number) to be included during registration.\n\n\nASTM E1578-18 C-1-5\n\n1.6 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.\n\n\nASTM E1578-18 C-1-6\n\n1.7 The system should offer safety information related to a submitted sample upon registration that is relevant to the lab's location and industry.\n\n\nASTM E1578-18 C-1-7\n\n1.8 The system should support the creation and use of predefined metadata templates, as well as ad-hoc, single, and multiple samples.\n\n\n\n7 CFR Part 91.19\r\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 1.1149\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 58.105 (c)\r\n\n21 CFR Part 58.195\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.170\r\n\n21 CFR Part 211.194\r\n\n21 CFR Part 312.57 (d)\r\n\n40 CFR Part 141.33\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1105\r\n\n42 CFR Part 493.1241\r\n\n42 CFR Part 493.1242\r\n\n42 CFR Part 493.1274 (f)\r\n\n42 CFR Part 493.1283\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.2\u20133\r\n\nAAVLD Requirements for an AVMDL Sec. 5.7.1.2\r\n\nABFT Accreditation Manual Sec. D\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C2\r\n\nASTM E1578-18 C-1-8\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 6 and 8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8\r\n\nEPA 815-R-05-004 Supplement 1\r\n\nEPA ERLN Laboratory Requirements 3.2\r\n\nEPA ERLN Laboratory Requirements 4.4.10\u201311\r\n\nEPA ERLN Laboratory Requirements 4.7.1\u20136\r\n\nEPA QA\/G-5 2.2.2 and 2.2.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 11.4\r\n\nISO 15189:2012 5.7.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 6.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13\r\n\nUSDA Sampling Procedures for PDP 5.1\r\n\nWHO Technical Report Series, #986, Annex 2, 17.11 and 17.21\n\n\n1.9 The system shall be able to define the collection details for registered samples or specimens, including container size and type, number of containers, collection date and time, temperature, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.\n\n\n\nASTM E1578-18 C-1-9\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G1.4\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA ERLN Laboratory Requirements 3.2.1\r\n\nEPA ERLN Laboratory Requirements 4.4.5\n\n\n1.10 The system should allow for the addition of observations and descriptions to registered samples in the form of free text.\n\n\nASTM E1578-18 C-1-10\n\n1.11 The system should support the creation of user-definable default sample registration preferences and\/or input screens.\n\n\n\n21 CFR Part 1.1149\r\n\nASTM E1578-18 C-1-11\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7)\r\n\nWADA International Standard for Laboratories (ISL) 5.3.2\n\n\n1.12 The system should allow for the recording of sample delivery details such as deliverer, location, and date and time for a preregistered sample.\n\n\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 58.107 (c)\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1241\r\n\n42 CFR Part 493.1274\r\n\n42 CFR Part 493.1283\r\n\nAAVLD Requirements for an AVMDL Sec. 5.8.2\r\n\nABFT Accreditation Manual D-3\r\n\nASTM E1578-18 C-1-12\r\n\nCAP Laboratory Accreditation Manual\r\n\nEPA ERLN Laboratory Requirements 3.2.2\r\n\nEPA ERLN Laboratory Requirements 4.1.11\r\n\nEPA ERLN Laboratory Requirements 4.4.10\r\n\nEPA QA\/G-5 2.2.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 15\r\n\nISO\/IEC 17025:2017 7.4.2\r\n\nOECD GLP Principles 6.2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.1.11\r\n\nUSDA Sampling Procedures for PDP 6.4.1.2.5\r\n\nWADA International Standard for Laboratories (ISL) 5.3.2\r\n\nWHO Technical Report Series, #986, Annex 2, 17.11\n\n\n1.13 The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 58.107 (d)\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 73.17\r\n\nASTM E1578-18 C-1-13\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA ERLN Laboratory Requirements 4.4.7\r\n\nEPA QA\/G-5 2.2.3\r\n\nOECD GLP Principles 6.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3)\n\n\n1.14 The system shall provide a user-friendly means for tracking and acknowledging the physical reception of submitted sample or specimen material in the laboratory, including date and time of reception.\n\n\n\n21 CFR Part 1.1149\r\n\nASTM E1578-18 C-1-14\r\n\nEPA ERLN Laboratory Requirements 4.4.6\n\n\n1.15 The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.\n\n\n\nACMG Technical Standards for Clinical Genetics Laboratories C3.3\r\n\nAAVLD Requirements for an AVMDL Sec. 5.8.3\r\n\nASTM E1492-11 4.1.1.5\r\n\nASTM E1492-11 4.1.6\r\n\nASTM E1492-11 4.3.3.2\r\n\nASTM E1578-18 C-1-15\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA ERLN Laboratory Requirements 4.4.13\r\n\nEPA ERLN Laboratory Requirements 4.11.8\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.1.3\u20137\r\n\nUSDA Sampling Procedures for PDP 6.4.1.1.9\r\n\nWADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1\n\n\n1.16 The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.\n\n\n\n21 CFR Part 1.1149\r\n\nA2LA C211 5.7\r\n\nASTM E1578-18 C-1-16\r\n\nEPA QA\/G-5 2.2.2 and 2.2.3\n\n\n1.17 The system should provide a means to document sample preparation activities for a given sample.\n\n\n\n7 CFR Part 331.11\r\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.11\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 1.1149\r\n\n21 CFR Part 1.1152 (d)\r\n\n42 CFR Part 73.11\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1274\r\n\nA2LA C223 4.13\r\n\nA2LA C223 5.8\r\n\nABFT Accreditation Manual Sec. D-9\u201310\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1\r\n\nASTM E1492-11 (throughout)\r\n\nASTM E1578-18 C-1-17\r\n\nCLSI QMS22 2.2.3.5\r\n\nEPA 815-R-05-004 Chap. III, Sec. 12\r\n\nEPA 815-R-05-004 Appendix A\r\n\nEPA ERLN Laboratory Requirements 3.2.3\u20135\r\n\nEPA ERLN Laboratory Requirements 4.1.13\r\n\nEPA ERLN Laboratory Requirements 4.4.8\u20139\r\n\nEPA QA\/G-5 2.2.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)\r\n\nWADA International Standard for Laboratories (ISL) (throughout)\n\n\n1.18 The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.\n\n\n7 CFR Part 331.16\r\n9 CFR Part 121.16\r\n42 CFR Part 73.16\n\n1.19 In the case of regulated samples (e.g., select agent or toxin, cannabis, etc.), the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required information.\n\n\nACMG Technical Standards for Clinical Genetics Laboratories G1.1\r\nAPHL 2019 LIS Project Management Guidebook\n\n1.20 The system shall be able to link various records together based on a record's metadata, including sample or specimen identifier, patient number, or family identifier.\n\n\n\n2. Sample management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASTM E1578-18 C-2-1\r\n\nEPA ERLN Laboratory Requirements 4.11.14\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2\n\n\n2.1 The system shall record and maintain the chain of custody for the laboratory's standards and reagents.\n\n\nASTM E1578-18 C-2-2\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.2 The system shall record the current and historical storage location for the laboratory's standards and reagents.\n\n\nASTM E1578-18 C-2-3\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.3 The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.\n\n\nASTM E1578-18 C-2-4\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.4 The system shall require the recording of a standard and reagent's first opening date.\n\n\nASTM E1578-18 C-2-5\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.5 The system shall allow only active standards and reagents to be shown as available for use.\n\n\nASTM E1578-18 C-2-6\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.6 The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.\n\n\nASTM E1578-18 C-2-7\n\n2.7 The system shall allow logically associated samples or specimens to be grouped together based on associated metadata such as type, test method, assigned user, and status.\n\n\nASTM E1578-18 C-2-8\r\nEPA ERLN Laboratory Requirements 3.2\r\nISO\/IEC 17025:2017 7.4.2\n\n2.8 The system should allow for the accurate identification of a physical sample or specimen in the system via barcode or RFID technology.\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 211.84\r\n\n42 CFR Part 73.17\r\n\nASTM E1492-11 4.2.1\r\n\nASTM E1578-18 C-2-9\r\n\nCAP Laboratory Accreditation Manual\n\n\n2.9 The system should provide a means to manually or automatically track sample or specimen inventory amounts and status.\n\n\n\n21 CFR Part 1.1152 (d)\r\n\nA2LA C211 5.4\r\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1\r\nASTM E1578-18 C-2-10\n\n\n2.10 The system shall be able to link test methods and specifications to standards and reagents.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 1.1153 (c)\r\n\n21 CFR Part 111.315\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.166\u20137\r\n\n21 CFR Part 211.194 (e)\r\n\n21 CFR Part 212.40 (c)\r\n\n21 CFR Part 212.61\r\n\n21 CFR Part 212.70 (e)\r\n\n21 CFR Part 225.58\r\n\n21 CFR Part 226.58\r\n\n21 CFR Part 606.65 (c)\r\n\n21 CFR Part 606.151\r\n\nA2LA C223 5.9\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.2\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C10\u201312\r\n\nCAP Laboratory Accreditation Manual\r\n\nASTM E1578-18 C-2-11\r\n\nEPA ERLN Laboratory Requirements 3.1.2.1\r\n\nEPA ERLN Laboratory Requirements 4.3.2\r\n\nEPA ERLN Laboratory Requirements 4.11.3.2\r\n\nEPA QA\/G-5 2.2.5\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)\r\n\nUSDA Administrative Procedures for the PDP 8.5\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\nWADA International Standard for Laboratories (ISL) 5.3.7\r\n\nWHO Technical Report Series, #961, Annex 13, 12.1\r\n\nWHO Technical Report Series, #986, Annex 2, 17.7\r\n\nWHO Technical Report Series, #986, Annex 2, 17.22\u201325\n\n\n2.11 The system shall allow samples, specimens, and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, remediated testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.\n\n\n\n3. Core laboratory testing and experiments \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 111.315\r\n\n21 CFR Part 211.84 (d)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1\r\n\nASTM E1578-18 C-3-1\r\n\nCLSI QMS22 2.2.2.1\r\n\nISO 15189:2012 5.3.2.7\r\n\nWADA International Standard for Laboratories (ISL) 5.2.7\n\n\n3.1 The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.\n\n\n\n21 CFR Part 211.84 (e)\r\n\n42 CFR Part 493.1252 (d)\r\n\nASTM E1578-18 C-3-2\r\n\nWADA International Standard for Laboratories (ISL) 5.2.7\n\n\n3.2 The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.\n\n\n42 CFR Part 493.1252 (d)\r\nASTM E1578-18 C-3-3\n\n3.3 The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.\n\n\nASTM E1578-18 C-3-4\n\n3.4 The system shall be able to check physical, control, and specification limits for an instrument sample.\n\n\nASTM E1578-18 C-3-6\n\n3.5 The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.\n\n\nASTM E1578-18 C-3-7\n\n3.6 The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.\n\n\nASTM E1578-18 C-3-8\n\n3.7 The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.\n\n\nASTM E1578-18 C-3-9\n\n3.8 The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.\n\n\nASTM E1578-18 C-3-10\n\n3.9 The system shall support, at a minimum, the floating point\/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.\n\n\nAIHA-LAP Policies 2022 2A.7.8.2\r\nASTM E1578-18 C-3-11\n\n3.10 The system shall allow users to enter operators such as <, >, +, and - with numeric test results.\n\n\nASTM E1578-18 C-3-12\n\n3.11 The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.\n\n\n42 CFR Part 493.1241\r\nASTM E1578-18 C-3-13\r\nEPA ERLN Laboratory Requirements 4.9.11\n\n3.12 The system should effectively alert users upon entry of out-of-specification test results.\n\n\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 1.1153 (c)\r\n\n21 CFR Part 106.100 (c\u2013f)\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.325\r\n\n21 CFR Part 112.161\r\n\n21 CFR Part 114.100 (a)\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.194\r\n\n21 CFR Part 212.60 (g)\r\n\n21 CFR Part 507.202\r\n\n21 CFR Part 606.160\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G16.1\r\n\nA2LA C223 5.10\nASTM E1578-18 C-3-14\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.1\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCLSI QMS22 2.1.2\r\n\nCLSI QMS22 2.2.2.1\r\n\nEPA ERLN Laboratory Requirements 3.1.2.3\u20134\r\n\nEPA ERLN Laboratory Requirements 3.2\r\n\nEPA ERLN Laboratory Requirements 4.3.4\r\n\nEPA ERLN Laboratory Requirements 4.8.1\u20134\r\n\nEPA ERLN Laboratory Requirements 4.11.16\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section II.4.i\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c\r\n\nIFS Food 7, Part 2, 4.18.3\r\n\nIFS PACsecure 2, Part 2, 4.18.3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.4.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6\r\n\nUSDA Data and Instrumentation for PDP 5.4.2\r\n\nUSDA Data and Instrumentation for PDP 8.1.3\r\n\nWHO Technical Report Series, #986, Annex 2, 15.8\n\n\n3.13 The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.\n\n\nWADA International Standard for Laboratories (ISL) 1.2\n\n3.14 The system shall allow users to link samples, specimens, and tests to a specific accreditation approval status (e.g., World Anti-Doping Agency accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.\n\n\n\n4. Results review and verification \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 211.68 (b)\r\n\n42 CFR Part 493.1241\r\n\nASTM E1578-18 C-4-1\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.1.2\r\n\nEPA ERLN Laboratory Requirements 4.9.11\r\n\nEPA QA\/G-5 2.4.1\r\n\nISO 15189:2012 5.5.1.4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.\n\n\n\nASTM E1578-18 C-4-2\r\n\nCLSI AUTO15 1.2\nEPA ERLN Laboratory Requirements 4.9.2\r\n\nEPA ERLN Laboratory Requirements 4.9.11\r\n\nEPA QA\/G-5 2.4.1\r\n\nISO 15189:2012 5.9.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\n\n4.2 The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.\n\n\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 C-4-3\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCLSI QMS22 2.2.2.2\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nICH GCP 4.9.0 and 4.9.3\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12\n\n\n4.3 The system shall accurately maintain a full audit trail for modified results.\n\n\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 211.68 (b)\r\n\nA2LA C211 5.9.1\r\n\nA2LA C223 4.13\r\n\nABFT Accreditation Manual Sec. E-28\u201329\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G15.1\r\n\nAIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4\u20135\r\n\nASTM E1578-18 C-4-4\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.2.2\r\n\nEPA ERLN Laboratory Requirements 3.2.6\r\n\nEPA ERLN Laboratory Requirements 4.9.2\u20133 and 4.9.11\r\n\nEPA ERLN Laboratory Requirements 4.11.4\r\n\nEPA QA\/G-5 2.2.10\r\n\nEPA QA\/G-5 2.4.1\r\n\nE.U. Annex 11-6\r\n\nIFS Food 7, Part 2, 5.6.4\r\n\nIFS PACsecure 2, Part 2, 5.6.4\r\n\nISO 15189:2012 5.7.1\r\n\nISO\/IEC 17025:2017 7.8.1.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nUSDA Data and Instrumentation for PDP 10\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.1\r\n\nWHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1\n\n\n4.4 The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.\n\n\n\nASTM E1578-18 C-4-5\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nBRC GSFS, Issue 8, 5.6.2.5\r\n\nEPA ERLN Laboratory Requirements 4.9.11\r\n\nEPA QA\/G-5 2.2.10\r\n\nEPA QA\/G-5 2.4.1\r\n\nE.U. Annex 11-6\r\n\nIFS Food 7, Part 2, 5.6.4\r\n\nIFS PACsecure 2, Part 2, 5.6.4\r\n\nISO 15189:2012 5.9.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n4.5 The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.\n\n\n\nASTM E1578-18 C-4-6\r\n\nEPA QA\/G-5 2.2.10\r\n\nEPA QA\/G-5 2.4.1\r\n\nE.U. Annex 11-6\n\n\n4.6 The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.\n\n\nCAP Laboratory Accreditation Manual\r\nCLSI AUTO15 4.0\r\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n4.7 The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.\n\n\n\n 5. Sample, experiment, and study approval and verification \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASTM E1578-18 C-5-1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.3.5\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.9\u201310\r\n\nWADA International Standard for Laboratories (ISL) 5.3.12.1\n\n\n5.1 The system shall accurately record details of a sample or specimen's final disposition.\n\n\n\nAIHA-LAP Policies 2022 2A.7.7.2\r\n\nASTM E1578-18 C-5-2\r\n\nCLSI QMS22 2.2.2.2\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12\n\n\n5.2 The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.\n\n\n21 CFR Part 211.160 (b)\r\nASTM E1578-18 C-5-3\r\nEPA 815-R-05-004 Chap. IV, Sec. 6.1\n\n5.3 The system should provide appropriate functions for specific sample statuses like \"approved\" and \"rejected,\" including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.\n\n\n\n6. Reporting \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 C-6-1\n\n6.1 The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.\n\n\nEPA ERLN Laboratory Requirements 3.4\r\nEPA ERLN Laboratory Requirements 4.1.4\r\nEPA ERLN Laboratory Requirements 4.12\u201315\n\n6.2 The system shall be able to export data in a computer-readable (importable into a relational database) format\u2014such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file\u2014as well as PDF format, for reporting purposes.\n\n\n\n42 CFR Part 493.1291 (g) and (h)\r\n\nACMG Technical Standards for Clinical Genetics Laboratories F7.2\r\n\nASTM E1578-18 C-6-2\r\n\nCLSI QMS22 2.1.2.1\r\n\nEPA ERLN Laboratory Requirements 4.11.4\r\n\nEPA QA\/G-5 2.4.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n6.3 The system shall alert stakeholders in advance to cases when the analyzed sample may be out-of-specification or may not meet expected turnaround time requirements.\n\n\nABFT Accreditation Manual Sec. G-2\n\n6.4 The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., \"less than X mg\/L\") when doing so would provide relevant information to the report recipient.\n\n\n\n7 CFR Part 91.25\r\n\n21 CFR Part 1.1152 (d)\r\n\n40 CFR Part 141.33\r\n\n42 CFR Part 493.1291 (c\u2013e)\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.1\r\n\nAAVLD Requirements for an AVMDL Sec. 5.10.2\u20135\r\n\nAIHA-LAP Policies 2022 2A.7.8.1\r\n\nABFT Accreditation Manual Sec. E-12 and -32\r\n\nASTM E1578-18 C-6-3\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8\r\n\nISO 15189:2012 4.5.2\r\n\nISO 15189:2012 5.8.3\r\n\nISO\/IEC 17025:2017 7.5.1\r\n\nISO\/IEC 17025:2017 7.8.1.1\r\n\nISO\/IEC 17025:2017 7.8.2.1\r\n\nISO\/IEC 17025:2017 7.8.3.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d\r\n\nWHO Technical Report Series, #986, Annex 2, 15.43\n\n\n6.5 The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates.\n\n\n7 CFR Part 91.26\u201327\r\n21 CFR Part 1.1152 (d)\r\nASTM E1578-18 C-6-4\n\n6.6 The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.\n\n\n\nA2LA C211 5.10\r\n\nASTM E1578-18 C-6-5\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCLSI QMS22 2.2.3\r\n\nISO 15189:2012 5.8.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.4\n\n\n6.7 The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, patient results, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.\n\n\n\n7 CFR Part 331.5\r\n\n9 CFR Part 121.5\u20136\r\n\n21 CFR Part 1.1110\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n21 CFR Part 58.185\r\n\n21 CFR Part 312.64\r\n\n21 CFR Part 812.150\r\n\n40 CFR Part 141.31\r\n\n40 CFR Part 141.721\r\n\n40 CFR Part 370 Subpart C\r\n\n40 CFR Part 372 Subpart B\r\n\n40 CFR Part 704\r\n\n40 CFR Part 717 Subpart A\r\n\n40 CFR Part 720.40\r\n\n42 CFR Part 73.5\u20136\r\n\n42 CFR Part 493.43 (d)\r\n\nABFT Accreditation Manual Sec. E-7\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C13.3\r\n\nACMG Technical Standards for Clinical Genetics Laboratories E8\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G17.1\r\n\nASTM E1578-18 C-6-7\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.3.1\r\n\nEPA ERLN Laboratory Requirements 4.12\u201315\r\n\nEPA QA\/G-5 2.3.2\r\n\nIFS Food 7, Part 4, 2.x\r\n\nIFS PACsecure 2, Part 4, 1.x\r\n\nNIST 800-53, Rev. 5, IR-6 and IR-6(1)\r\n\nOECD GLP Principles 9.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.4\n\n\n6.8 The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, analytical worksheets, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.\n\n\n\n7 CFR Part 91.28\r\n\n21 CFR Part 1.1154 (c)\r\n\n21 CFR Part 58 Sec. 58.185 (c)\r\n\nA2LA C211 5.10.9\r\n\nAAVLD Requirements for an AVMDL Sec. 5.10.9\u201310\r\n\nCLSI QMS22 2.2.3.4\r\n\nICH GCP 4.9.3\r\n\nISO\/IEC 17025:2017 7.8.8\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 9.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)\r\n\n\n\n6.9 The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#4._Results_review_and_verification\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#4._Results_review_and_verification<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 20 September 2019, at 17:58.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2,200 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","0275d5f4b1bd7bd8c861ef8f0795dfb6_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Primary_Laboratory_Workflow rootpage-LII_LIMSpec_Primary_Laboratory_Workflow skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Primary Laboratory Workflow<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the core of your typical laboratory workflow, from sample\/specimen receipt and sampling procedures, to analysis, review, and reporting.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"1._Sample_and_experiment_registration\">1. Sample and experiment registration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.1<\/b> The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.121\" target=\"_blank\">21 CFR Part 606.121 (c\u2013i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.140\" target=\"_blank\">21 CFR Part 606.140 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e1-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 15<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.2<\/b> The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/162.410\" target=\"_blank\">45 CFR Part 162.410<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.3<\/b> The system shall provide a means to assign unique identifiers such as a National Provider Identifier (NPI) or Originating Agency Identifier (ORI) to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.4<\/b> The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.19\" target=\"_blank\">7 CFR Part 91.19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.18\" target=\"_blank\">40 CFR Part 262.18<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.5<\/b> The system should permit unique metadata like lot number, patient number, family identifier, client or patient demographics, sampling point, random selection process used, and industry-specific items (like EPA identification number or U.S. Customs and Border Protection number) to be included during registration.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.6<\/b> The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.7<\/b> The system should offer safety information related to a submitted sample upon registration that is relevant to the lab's location and industry.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.8<\/b> The system should support the creation and use of predefined metadata templates, as well as ad-hoc, single, and multiple samples.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.19\" target=\"_blank\">7 CFR Part 91.19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.195<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.170\" target=\"_blank\">21 CFR Part 211.170<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1105\" target=\"_blank\">42 CFR Part 493.1105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1242\" target=\"_blank\">42 CFR Part 493.1242<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.7.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6 and 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=P1000PUE.txt\" target=\"_blank\">EPA 815-R-05-004 Supplement 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.10\u201311<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.7.1\u20136<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.2 and 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11 and 17.21<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.9<\/b> The system shall be able to define the collection details for registered samples or specimens, including container size and type, number of containers, collection date and time, temperature, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.10<\/b> The system should allow for the addition of observations and descriptions to registered samples in the form of free text.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.11<\/b> The system should support the creation of user-definable default sample registration preferences and\/or input screens.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.12<\/b> The system should allow for the recording of sample delivery details such as deliverer, location, and date and time for a preregistered sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.107\" target=\"_blank\">21 CFR Part 58.107 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.8.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual D-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.13<\/b> The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.107\" target=\"_blank\">21 CFR Part 58.107 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.14<\/b> The system shall provide a user-friendly means for tracking and acknowledging the physical reception of submitted sample or specimen material in the laboratory, including date and time of reception.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.15<\/b> The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1.3\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.16<\/b> The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.2 and 2.2.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.17<\/b> The system should provide a means to document sample preparation activities for a given sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D-9\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Appendix A<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.3\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.8\u20139<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.18<\/b> The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.16\" target=\"_blank\">7 CFR Part 331.16<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.16\" target=\"_blank\">9 CFR Part 121.16<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.16\" target=\"_blank\">42 CFR Part 73.16<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.19<\/b> In the case of regulated samples (e.g., select agent or toxin, cannabis, etc.), the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.20<\/b> The system shall be able to link various records together based on a record's metadata, including sample or specimen identifier, patient number, or family identifier.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"2._Sample_management\">2. Sample management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.1<\/b> The system shall record and maintain the chain of custody for the laboratory's standards and reagents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.2<\/b> The system shall record the current and historical storage location for the laboratory's standards and reagents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.3<\/b> The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.4<\/b> The system shall require the recording of a standard and reagent's first opening date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.5<\/b> The system shall allow only active standards and reagents to be shown as available for use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.6<\/b> The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.7<\/b> The system shall allow logically associated samples or specimens to be grouped together based on associated metadata such as type, test method, assigned user, and status.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.8<\/b> The system should allow for the accurate identification of a physical sample or specimen in the system via barcode or RFID technology.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.9<\/b> The system should provide a means to manually or automatically track sample or specimen inventory amounts and status.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.10<\/b> The system shall be able to link test methods and specifications to standards and reagents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1153 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.65\" target=\"_blank\">21 CFR Part 606.65 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.151\" target=\"_blank\">21 CFR Part 606.151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10\u201312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 12.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.22\u201325<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.11<\/b> The system shall allow samples, specimens, and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, remediated testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"3._Core_laboratory_testing_and_experiments\">3. Core laboratory testing and experiments<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>3.1<\/b> The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>3.2<\/b> The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.3<\/b> The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.4<\/b> The system shall be able to check physical, control, and specification limits for an instrument sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.5<\/b> The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.6<\/b> The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.7<\/b> The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.8<\/b> The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.9<\/b> The system shall support, at a minimum, the floating point\/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.10<\/b> The system shall allow users to enter operators such as <, >, +, and - with numeric test results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.11<\/b> The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-13<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.12<\/b> The system should effectively alert users upon entry of out-of-specification test results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1153 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (c\u2013f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.325<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.161<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.202<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.160\" target=\"_blank\">21 CFR Part 606.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G16.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.10<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.1.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.1\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section II.4.i<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>3.13<\/b> The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 1.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.14<\/b> The system shall allow users to link samples, specimens, and tests to a specific accreditation approval status (e.g., World Anti-Doping Agency accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"4._Results_review_and_verification\">4. Results review and verification<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.1<\/b> The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 1.2<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.2<\/b> The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.3<\/b> The system shall accurately maintain a full audit trail for modified results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-28\u201329<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G15.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.2\u20133 and 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.4<\/b> The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.5<\/b> The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.6<\/b> The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 4.0<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>4.7<\/b> The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span id=\"rdp-ebb-5._Sample,_experiment,_and_study_approval_and_verification\"><\/span><span class=\"mw-headline\" id=\"5._Sample.2C_experiment.2C_and_study_approval_and_verification\">5. Sample, experiment, and study approval and verification<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.9\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.12.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>5.1<\/b> The system shall accurately record details of a sample or specimen's final disposition.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>5.2<\/b> The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>5.3<\/b> The system should provide appropriate functions for specific sample statuses like \"approved\" and \"rejected,\" including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"6._Reporting\">6. Reporting<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.1<\/b> The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.12\u201315<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.2<\/b> The system shall be able to export data in a computer-readable (importable into a relational database) format\u2014such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file\u2014as well as PDF format, for reporting purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (g) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.3<\/b> The system shall alert stakeholders in advance to cases when the analyzed sample may be out-of-specification or may not meet expected turnaround time requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.4<\/b> The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., \"less than X mg\/L\") when doing so would provide relevant information to the report recipient.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.25\" target=\"_blank\">7 CFR Part 91.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (c\u2013e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.10.2\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-12 and -32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.43<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.5<\/b> The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.26\" target=\"_blank\">7 CFR Part 91.26\u201327<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.6<\/b> The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.7<\/b> The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, patient results, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.5\" target=\"_blank\">7 CFR Part 331.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.5\" target=\"_blank\">9 CFR Part 121.5\u20136<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.185\" target=\"_blank\">21 CFR Part 58.185<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.64\" target=\"_blank\">21 CFR Part 312.64<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.150\" target=\"_blank\">21 CFR Part 812.150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.31\" target=\"_blank\">40 CFR Part 141.31<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.721\" target=\"_blank\">40 CFR Part 141.721<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-370\/subpart-C\" target=\"_blank\">40 CFR Part 370 Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-372\/subpart-B\" target=\"_blank\">40 CFR Part 372 Subpart B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\" target=\"_blank\">40 CFR Part 704<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-717\/subpart-A\" target=\"_blank\">40 CFR Part 717 Subpart A<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/720.40\" target=\"_blank\">40 CFR Part 720.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.5\" target=\"_blank\">42 CFR Part 73.5\u20136<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C13.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories E8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G17.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.12\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 4, 2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 4, 1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-6 and IR-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.8<\/b> The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, analytical worksheets, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.28\" target=\"_blank\">7 CFR Part 91.28<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.185\" target=\"_blank\">21 CFR Part 58 Sec. 58.185 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.10.9\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.9<\/b> The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173540\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.057 seconds\nReal time usage: 0.060 seconds\nPreprocessor visited node count: 482\/1000000\nPost\u2010expand include size: 76839\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 11.378 1 -total\n 17.77% 2.022 1 Template:LIMSpec\/Sample_and_experiment_registration\n 15.99% 1.820 1 Template:LIMSpec\/Reporting\n 15.94% 1.813 1 Template:LIMSpec\/Results_review_and_verification\n 15.92% 1.811 1 Template:LIMSpec\/Sample_management\n 15.51% 1.765 1 Template:LIMSpec\/Core_laboratory_testing_and_experiments\n 14.69% 1.671 1 Template:LIMSpec\/Sample,_experiment,_and_study_approval_and_verification\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11179-0!canonical and timestamp 20221202173540 and revision id 36389. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#4._Results_review_and_verification\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#4._Results_review_and_verification<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","0275d5f4b1bd7bd8c861ef8f0795dfb6_images":[],"0275d5f4b1bd7bd8c861ef8f0795dfb6_timestamp":1670002541,"391eb403b8e74d30746c87a3dd134f66_type":"article","391eb403b8e74d30746c87a3dd134f66_title":"3. Core laboratory testing and experiments","391eb403b8e74d30746c87a3dd134f66_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#3._Core_laboratory_testing_and_experiments","391eb403b8e74d30746c87a3dd134f66_plaintext":"\n\nLII:LIMSpec\/Primary Laboratory WorkflowFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the core of your typical laboratory workflow, from sample\/specimen receipt and sampling procedures, to analysis, review, and reporting.\n\n1. Sample and experiment registration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 1.1149\r\n\n42 CFR Part 493.1241\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 C-1-1\n\n\n1.1 The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.\n\n\n\n21 CFR Part 58.105 (c)\r\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.101\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 606.120 (b)\r\n\n21 CFR Part 606.121 (c\u2013i)\r\n\n21 CFR Part 606.140 (c)\r\n\n29 CFR Part 1910.1030 (g)\r\n\n29 CFR Part 1910.1096 (e1-6)\r\n\n42 CFR Part 493.1232\r\n\nABFT Accreditation Manual Sec. D\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1492-11 4.1.1.6\r\n\nASTM E1578-18 C-1-2\r\n\nCLSI QMS22 2.2.1.2\r\n\nEPA ERLN Laboratory Requirements 3.2.2\r\n\nEPA QA\/G-5 2.2.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 15\r\nOECD GLP Principles 6.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)\r\n\nUSDA Sampling Procedures for PDP 6.4.1.2.6\r\n\nWHO Technical Report Series, #986, Annex 2, 17.11\n\n\n1.2 The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.\n\n\n45 CFR Part 162.410\r\nCJIS Security Policy 5.6.1\n\n1.3 The system shall provide a means to assign unique identifiers such as a National Provider Identifier (NPI) or Originating Agency Identifier (ORI) to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.\n\n\n42 CFR Part 493.1241\r\nASTM E1578-18 C-1-3\n\n1.4 The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.\n\n\n\n7 CFR Part 91.19\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n40 CFR Part 262.18\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C2.1\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 C-1-4\r\n\nUSDA Sampling Procedures for PDP 6.4.1.1.3\n\n\n1.5 The system should permit unique metadata like lot number, patient number, family identifier, client or patient demographics, sampling point, random selection process used, and industry-specific items (like EPA identification number or U.S. Customs and Border Protection number) to be included during registration.\n\n\nASTM E1578-18 C-1-5\n\n1.6 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.\n\n\nASTM E1578-18 C-1-6\n\n1.7 The system should offer safety information related to a submitted sample upon registration that is relevant to the lab's location and industry.\n\n\nASTM E1578-18 C-1-7\n\n1.8 The system should support the creation and use of predefined metadata templates, as well as ad-hoc, single, and multiple samples.\n\n\n\n7 CFR Part 91.19\r\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 1.1149\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 58.105 (c)\r\n\n21 CFR Part 58.195\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.170\r\n\n21 CFR Part 211.194\r\n\n21 CFR Part 312.57 (d)\r\n\n40 CFR Part 141.33\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1105\r\n\n42 CFR Part 493.1241\r\n\n42 CFR Part 493.1242\r\n\n42 CFR Part 493.1274 (f)\r\n\n42 CFR Part 493.1283\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.2\u20133\r\n\nAAVLD Requirements for an AVMDL Sec. 5.7.1.2\r\n\nABFT Accreditation Manual Sec. D\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C2\r\n\nASTM E1578-18 C-1-8\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 6 and 8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8\r\n\nEPA 815-R-05-004 Supplement 1\r\n\nEPA ERLN Laboratory Requirements 3.2\r\n\nEPA ERLN Laboratory Requirements 4.4.10\u201311\r\n\nEPA ERLN Laboratory Requirements 4.7.1\u20136\r\n\nEPA QA\/G-5 2.2.2 and 2.2.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 11.4\r\n\nISO 15189:2012 5.7.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 6.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13\r\n\nUSDA Sampling Procedures for PDP 5.1\r\n\nWHO Technical Report Series, #986, Annex 2, 17.11 and 17.21\n\n\n1.9 The system shall be able to define the collection details for registered samples or specimens, including container size and type, number of containers, collection date and time, temperature, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.\n\n\n\nASTM E1578-18 C-1-9\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G1.4\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA ERLN Laboratory Requirements 3.2.1\r\n\nEPA ERLN Laboratory Requirements 4.4.5\n\n\n1.10 The system should allow for the addition of observations and descriptions to registered samples in the form of free text.\n\n\nASTM E1578-18 C-1-10\n\n1.11 The system should support the creation of user-definable default sample registration preferences and\/or input screens.\n\n\n\n21 CFR Part 1.1149\r\n\nASTM E1578-18 C-1-11\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7)\r\n\nWADA International Standard for Laboratories (ISL) 5.3.2\n\n\n1.12 The system should allow for the recording of sample delivery details such as deliverer, location, and date and time for a preregistered sample.\n\n\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 58.107 (c)\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1241\r\n\n42 CFR Part 493.1274\r\n\n42 CFR Part 493.1283\r\n\nAAVLD Requirements for an AVMDL Sec. 5.8.2\r\n\nABFT Accreditation Manual D-3\r\n\nASTM E1578-18 C-1-12\r\n\nCAP Laboratory Accreditation Manual\r\n\nEPA ERLN Laboratory Requirements 3.2.2\r\n\nEPA ERLN Laboratory Requirements 4.1.11\r\n\nEPA ERLN Laboratory Requirements 4.4.10\r\n\nEPA QA\/G-5 2.2.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 15\r\n\nISO\/IEC 17025:2017 7.4.2\r\n\nOECD GLP Principles 6.2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.1.11\r\n\nUSDA Sampling Procedures for PDP 6.4.1.2.5\r\n\nWADA International Standard for Laboratories (ISL) 5.3.2\r\n\nWHO Technical Report Series, #986, Annex 2, 17.11\n\n\n1.13 The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 58.107 (d)\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 73.17\r\n\nASTM E1578-18 C-1-13\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA ERLN Laboratory Requirements 4.4.7\r\n\nEPA QA\/G-5 2.2.3\r\n\nOECD GLP Principles 6.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3)\n\n\n1.14 The system shall provide a user-friendly means for tracking and acknowledging the physical reception of submitted sample or specimen material in the laboratory, including date and time of reception.\n\n\n\n21 CFR Part 1.1149\r\n\nASTM E1578-18 C-1-14\r\n\nEPA ERLN Laboratory Requirements 4.4.6\n\n\n1.15 The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.\n\n\n\nACMG Technical Standards for Clinical Genetics Laboratories C3.3\r\n\nAAVLD Requirements for an AVMDL Sec. 5.8.3\r\n\nASTM E1492-11 4.1.1.5\r\n\nASTM E1492-11 4.1.6\r\n\nASTM E1492-11 4.3.3.2\r\n\nASTM E1578-18 C-1-15\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA ERLN Laboratory Requirements 4.4.13\r\n\nEPA ERLN Laboratory Requirements 4.11.8\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.1.3\u20137\r\n\nUSDA Sampling Procedures for PDP 6.4.1.1.9\r\n\nWADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1\n\n\n1.16 The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.\n\n\n\n21 CFR Part 1.1149\r\n\nA2LA C211 5.7\r\n\nASTM E1578-18 C-1-16\r\n\nEPA QA\/G-5 2.2.2 and 2.2.3\n\n\n1.17 The system should provide a means to document sample preparation activities for a given sample.\n\n\n\n7 CFR Part 331.11\r\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.11\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 1.1149\r\n\n21 CFR Part 1.1152 (d)\r\n\n42 CFR Part 73.11\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1274\r\n\nA2LA C223 4.13\r\n\nA2LA C223 5.8\r\n\nABFT Accreditation Manual Sec. D-9\u201310\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1\r\n\nASTM E1492-11 (throughout)\r\n\nASTM E1578-18 C-1-17\r\n\nCLSI QMS22 2.2.3.5\r\n\nEPA 815-R-05-004 Chap. III, Sec. 12\r\n\nEPA 815-R-05-004 Appendix A\r\n\nEPA ERLN Laboratory Requirements 3.2.3\u20135\r\n\nEPA ERLN Laboratory Requirements 4.1.13\r\n\nEPA ERLN Laboratory Requirements 4.4.8\u20139\r\n\nEPA QA\/G-5 2.2.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)\r\n\nWADA International Standard for Laboratories (ISL) (throughout)\n\n\n1.18 The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.\n\n\n7 CFR Part 331.16\r\n9 CFR Part 121.16\r\n42 CFR Part 73.16\n\n1.19 In the case of regulated samples (e.g., select agent or toxin, cannabis, etc.), the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required information.\n\n\nACMG Technical Standards for Clinical Genetics Laboratories G1.1\r\nAPHL 2019 LIS Project Management Guidebook\n\n1.20 The system shall be able to link various records together based on a record's metadata, including sample or specimen identifier, patient number, or family identifier.\n\n\n\n2. Sample management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASTM E1578-18 C-2-1\r\n\nEPA ERLN Laboratory Requirements 4.11.14\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2\n\n\n2.1 The system shall record and maintain the chain of custody for the laboratory's standards and reagents.\n\n\nASTM E1578-18 C-2-2\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.2 The system shall record the current and historical storage location for the laboratory's standards and reagents.\n\n\nASTM E1578-18 C-2-3\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.3 The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.\n\n\nASTM E1578-18 C-2-4\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.4 The system shall require the recording of a standard and reagent's first opening date.\n\n\nASTM E1578-18 C-2-5\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.5 The system shall allow only active standards and reagents to be shown as available for use.\n\n\nASTM E1578-18 C-2-6\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.6 The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.\n\n\nASTM E1578-18 C-2-7\n\n2.7 The system shall allow logically associated samples or specimens to be grouped together based on associated metadata such as type, test method, assigned user, and status.\n\n\nASTM E1578-18 C-2-8\r\nEPA ERLN Laboratory Requirements 3.2\r\nISO\/IEC 17025:2017 7.4.2\n\n2.8 The system should allow for the accurate identification of a physical sample or specimen in the system via barcode or RFID technology.\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 211.84\r\n\n42 CFR Part 73.17\r\n\nASTM E1492-11 4.2.1\r\n\nASTM E1578-18 C-2-9\r\n\nCAP Laboratory Accreditation Manual\n\n\n2.9 The system should provide a means to manually or automatically track sample or specimen inventory amounts and status.\n\n\n\n21 CFR Part 1.1152 (d)\r\n\nA2LA C211 5.4\r\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1\r\nASTM E1578-18 C-2-10\n\n\n2.10 The system shall be able to link test methods and specifications to standards and reagents.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 1.1153 (c)\r\n\n21 CFR Part 111.315\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.166\u20137\r\n\n21 CFR Part 211.194 (e)\r\n\n21 CFR Part 212.40 (c)\r\n\n21 CFR Part 212.61\r\n\n21 CFR Part 212.70 (e)\r\n\n21 CFR Part 225.58\r\n\n21 CFR Part 226.58\r\n\n21 CFR Part 606.65 (c)\r\n\n21 CFR Part 606.151\r\n\nA2LA C223 5.9\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.2\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C10\u201312\r\n\nCAP Laboratory Accreditation Manual\r\n\nASTM E1578-18 C-2-11\r\n\nEPA ERLN Laboratory Requirements 3.1.2.1\r\n\nEPA ERLN Laboratory Requirements 4.3.2\r\n\nEPA ERLN Laboratory Requirements 4.11.3.2\r\n\nEPA QA\/G-5 2.2.5\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)\r\n\nUSDA Administrative Procedures for the PDP 8.5\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\nWADA International Standard for Laboratories (ISL) 5.3.7\r\n\nWHO Technical Report Series, #961, Annex 13, 12.1\r\n\nWHO Technical Report Series, #986, Annex 2, 17.7\r\n\nWHO Technical Report Series, #986, Annex 2, 17.22\u201325\n\n\n2.11 The system shall allow samples, specimens, and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, remediated testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.\n\n\n\n3. Core laboratory testing and experiments \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 111.315\r\n\n21 CFR Part 211.84 (d)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1\r\n\nASTM E1578-18 C-3-1\r\n\nCLSI QMS22 2.2.2.1\r\n\nISO 15189:2012 5.3.2.7\r\n\nWADA International Standard for Laboratories (ISL) 5.2.7\n\n\n3.1 The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.\n\n\n\n21 CFR Part 211.84 (e)\r\n\n42 CFR Part 493.1252 (d)\r\n\nASTM E1578-18 C-3-2\r\n\nWADA International Standard for Laboratories (ISL) 5.2.7\n\n\n3.2 The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.\n\n\n42 CFR Part 493.1252 (d)\r\nASTM E1578-18 C-3-3\n\n3.3 The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.\n\n\nASTM E1578-18 C-3-4\n\n3.4 The system shall be able to check physical, control, and specification limits for an instrument sample.\n\n\nASTM E1578-18 C-3-6\n\n3.5 The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.\n\n\nASTM E1578-18 C-3-7\n\n3.6 The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.\n\n\nASTM E1578-18 C-3-8\n\n3.7 The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.\n\n\nASTM E1578-18 C-3-9\n\n3.8 The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.\n\n\nASTM E1578-18 C-3-10\n\n3.9 The system shall support, at a minimum, the floating point\/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.\n\n\nAIHA-LAP Policies 2022 2A.7.8.2\r\nASTM E1578-18 C-3-11\n\n3.10 The system shall allow users to enter operators such as <, >, +, and - with numeric test results.\n\n\nASTM E1578-18 C-3-12\n\n3.11 The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.\n\n\n42 CFR Part 493.1241\r\nASTM E1578-18 C-3-13\r\nEPA ERLN Laboratory Requirements 4.9.11\n\n3.12 The system should effectively alert users upon entry of out-of-specification test results.\n\n\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 1.1153 (c)\r\n\n21 CFR Part 106.100 (c\u2013f)\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.325\r\n\n21 CFR Part 112.161\r\n\n21 CFR Part 114.100 (a)\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.194\r\n\n21 CFR Part 212.60 (g)\r\n\n21 CFR Part 507.202\r\n\n21 CFR Part 606.160\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G16.1\r\n\nA2LA C223 5.10\nASTM E1578-18 C-3-14\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.1\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCLSI QMS22 2.1.2\r\n\nCLSI QMS22 2.2.2.1\r\n\nEPA ERLN Laboratory Requirements 3.1.2.3\u20134\r\n\nEPA ERLN Laboratory Requirements 3.2\r\n\nEPA ERLN Laboratory Requirements 4.3.4\r\n\nEPA ERLN Laboratory Requirements 4.8.1\u20134\r\n\nEPA ERLN Laboratory Requirements 4.11.16\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section II.4.i\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c\r\n\nIFS Food 7, Part 2, 4.18.3\r\n\nIFS PACsecure 2, Part 2, 4.18.3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.4.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6\r\n\nUSDA Data and Instrumentation for PDP 5.4.2\r\n\nUSDA Data and Instrumentation for PDP 8.1.3\r\n\nWHO Technical Report Series, #986, Annex 2, 15.8\n\n\n3.13 The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.\n\n\nWADA International Standard for Laboratories (ISL) 1.2\n\n3.14 The system shall allow users to link samples, specimens, and tests to a specific accreditation approval status (e.g., World Anti-Doping Agency accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.\n\n\n\n4. Results review and verification \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 211.68 (b)\r\n\n42 CFR Part 493.1241\r\n\nASTM E1578-18 C-4-1\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.1.2\r\n\nEPA ERLN Laboratory Requirements 4.9.11\r\n\nEPA QA\/G-5 2.4.1\r\n\nISO 15189:2012 5.5.1.4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.\n\n\n\nASTM E1578-18 C-4-2\r\n\nCLSI AUTO15 1.2\nEPA ERLN Laboratory Requirements 4.9.2\r\n\nEPA ERLN Laboratory Requirements 4.9.11\r\n\nEPA QA\/G-5 2.4.1\r\n\nISO 15189:2012 5.9.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\n\n4.2 The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.\n\n\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 C-4-3\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCLSI QMS22 2.2.2.2\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nICH GCP 4.9.0 and 4.9.3\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12\n\n\n4.3 The system shall accurately maintain a full audit trail for modified results.\n\n\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 211.68 (b)\r\n\nA2LA C211 5.9.1\r\n\nA2LA C223 4.13\r\n\nABFT Accreditation Manual Sec. E-28\u201329\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G15.1\r\n\nAIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4\u20135\r\n\nASTM E1578-18 C-4-4\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.2.2\r\n\nEPA ERLN Laboratory Requirements 3.2.6\r\n\nEPA ERLN Laboratory Requirements 4.9.2\u20133 and 4.9.11\r\n\nEPA ERLN Laboratory Requirements 4.11.4\r\n\nEPA QA\/G-5 2.2.10\r\n\nEPA QA\/G-5 2.4.1\r\n\nE.U. Annex 11-6\r\n\nIFS Food 7, Part 2, 5.6.4\r\n\nIFS PACsecure 2, Part 2, 5.6.4\r\n\nISO 15189:2012 5.7.1\r\n\nISO\/IEC 17025:2017 7.8.1.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nUSDA Data and Instrumentation for PDP 10\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.1\r\n\nWHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1\n\n\n4.4 The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.\n\n\n\nASTM E1578-18 C-4-5\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nBRC GSFS, Issue 8, 5.6.2.5\r\n\nEPA ERLN Laboratory Requirements 4.9.11\r\n\nEPA QA\/G-5 2.2.10\r\n\nEPA QA\/G-5 2.4.1\r\n\nE.U. Annex 11-6\r\n\nIFS Food 7, Part 2, 5.6.4\r\n\nIFS PACsecure 2, Part 2, 5.6.4\r\n\nISO 15189:2012 5.9.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n4.5 The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.\n\n\n\nASTM E1578-18 C-4-6\r\n\nEPA QA\/G-5 2.2.10\r\n\nEPA QA\/G-5 2.4.1\r\n\nE.U. Annex 11-6\n\n\n4.6 The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.\n\n\nCAP Laboratory Accreditation Manual\r\nCLSI AUTO15 4.0\r\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n4.7 The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.\n\n\n\n 5. Sample, experiment, and study approval and verification \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASTM E1578-18 C-5-1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.3.5\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.9\u201310\r\n\nWADA International Standard for Laboratories (ISL) 5.3.12.1\n\n\n5.1 The system shall accurately record details of a sample or specimen's final disposition.\n\n\n\nAIHA-LAP Policies 2022 2A.7.7.2\r\n\nASTM E1578-18 C-5-2\r\n\nCLSI QMS22 2.2.2.2\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12\n\n\n5.2 The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.\n\n\n21 CFR Part 211.160 (b)\r\nASTM E1578-18 C-5-3\r\nEPA 815-R-05-004 Chap. IV, Sec. 6.1\n\n5.3 The system should provide appropriate functions for specific sample statuses like \"approved\" and \"rejected,\" including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.\n\n\n\n6. Reporting \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 C-6-1\n\n6.1 The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.\n\n\nEPA ERLN Laboratory Requirements 3.4\r\nEPA ERLN Laboratory Requirements 4.1.4\r\nEPA ERLN Laboratory Requirements 4.12\u201315\n\n6.2 The system shall be able to export data in a computer-readable (importable into a relational database) format\u2014such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file\u2014as well as PDF format, for reporting purposes.\n\n\n\n42 CFR Part 493.1291 (g) and (h)\r\n\nACMG Technical Standards for Clinical Genetics Laboratories F7.2\r\n\nASTM E1578-18 C-6-2\r\n\nCLSI QMS22 2.1.2.1\r\n\nEPA ERLN Laboratory Requirements 4.11.4\r\n\nEPA QA\/G-5 2.4.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n6.3 The system shall alert stakeholders in advance to cases when the analyzed sample may be out-of-specification or may not meet expected turnaround time requirements.\n\n\nABFT Accreditation Manual Sec. G-2\n\n6.4 The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., \"less than X mg\/L\") when doing so would provide relevant information to the report recipient.\n\n\n\n7 CFR Part 91.25\r\n\n21 CFR Part 1.1152 (d)\r\n\n40 CFR Part 141.33\r\n\n42 CFR Part 493.1291 (c\u2013e)\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.1\r\n\nAAVLD Requirements for an AVMDL Sec. 5.10.2\u20135\r\n\nAIHA-LAP Policies 2022 2A.7.8.1\r\n\nABFT Accreditation Manual Sec. E-12 and -32\r\n\nASTM E1578-18 C-6-3\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8\r\n\nISO 15189:2012 4.5.2\r\n\nISO 15189:2012 5.8.3\r\n\nISO\/IEC 17025:2017 7.5.1\r\n\nISO\/IEC 17025:2017 7.8.1.1\r\n\nISO\/IEC 17025:2017 7.8.2.1\r\n\nISO\/IEC 17025:2017 7.8.3.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d\r\n\nWHO Technical Report Series, #986, Annex 2, 15.43\n\n\n6.5 The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates.\n\n\n7 CFR Part 91.26\u201327\r\n21 CFR Part 1.1152 (d)\r\nASTM E1578-18 C-6-4\n\n6.6 The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.\n\n\n\nA2LA C211 5.10\r\n\nASTM E1578-18 C-6-5\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCLSI QMS22 2.2.3\r\n\nISO 15189:2012 5.8.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.4\n\n\n6.7 The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, patient results, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.\n\n\n\n7 CFR Part 331.5\r\n\n9 CFR Part 121.5\u20136\r\n\n21 CFR Part 1.1110\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n21 CFR Part 58.185\r\n\n21 CFR Part 312.64\r\n\n21 CFR Part 812.150\r\n\n40 CFR Part 141.31\r\n\n40 CFR Part 141.721\r\n\n40 CFR Part 370 Subpart C\r\n\n40 CFR Part 372 Subpart B\r\n\n40 CFR Part 704\r\n\n40 CFR Part 717 Subpart A\r\n\n40 CFR Part 720.40\r\n\n42 CFR Part 73.5\u20136\r\n\n42 CFR Part 493.43 (d)\r\n\nABFT Accreditation Manual Sec. E-7\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C13.3\r\n\nACMG Technical Standards for Clinical Genetics Laboratories E8\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G17.1\r\n\nASTM E1578-18 C-6-7\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.3.1\r\n\nEPA ERLN Laboratory Requirements 4.12\u201315\r\n\nEPA QA\/G-5 2.3.2\r\n\nIFS Food 7, Part 4, 2.x\r\n\nIFS PACsecure 2, Part 4, 1.x\r\n\nNIST 800-53, Rev. 5, IR-6 and IR-6(1)\r\n\nOECD GLP Principles 9.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.4\n\n\n6.8 The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, analytical worksheets, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.\n\n\n\n7 CFR Part 91.28\r\n\n21 CFR Part 1.1154 (c)\r\n\n21 CFR Part 58 Sec. 58.185 (c)\r\n\nA2LA C211 5.10.9\r\n\nAAVLD Requirements for an AVMDL Sec. 5.10.9\u201310\r\n\nCLSI QMS22 2.2.3.4\r\n\nICH GCP 4.9.3\r\n\nISO\/IEC 17025:2017 7.8.8\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 9.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)\r\n\n\n\n6.9 The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#3._Core_laboratory_testing_and_experiments\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#3._Core_laboratory_testing_and_experiments<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 20 September 2019, at 17:58.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2,200 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","391eb403b8e74d30746c87a3dd134f66_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Primary_Laboratory_Workflow rootpage-LII_LIMSpec_Primary_Laboratory_Workflow skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Primary Laboratory Workflow<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the core of your typical laboratory workflow, from sample\/specimen receipt and sampling procedures, to analysis, review, and reporting.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"1._Sample_and_experiment_registration\">1. Sample and experiment registration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.1<\/b> The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.121\" target=\"_blank\">21 CFR Part 606.121 (c\u2013i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.140\" target=\"_blank\">21 CFR Part 606.140 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e1-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 15<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.2<\/b> The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/162.410\" target=\"_blank\">45 CFR Part 162.410<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.3<\/b> The system shall provide a means to assign unique identifiers such as a National Provider Identifier (NPI) or Originating Agency Identifier (ORI) to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.4<\/b> The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.19\" target=\"_blank\">7 CFR Part 91.19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.18\" target=\"_blank\">40 CFR Part 262.18<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.5<\/b> The system should permit unique metadata like lot number, patient number, family identifier, client or patient demographics, sampling point, random selection process used, and industry-specific items (like EPA identification number or U.S. Customs and Border Protection number) to be included during registration.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.6<\/b> The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.7<\/b> The system should offer safety information related to a submitted sample upon registration that is relevant to the lab's location and industry.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.8<\/b> The system should support the creation and use of predefined metadata templates, as well as ad-hoc, single, and multiple samples.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.19\" target=\"_blank\">7 CFR Part 91.19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.195<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.170\" target=\"_blank\">21 CFR Part 211.170<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1105\" target=\"_blank\">42 CFR Part 493.1105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1242\" target=\"_blank\">42 CFR Part 493.1242<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.7.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6 and 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=P1000PUE.txt\" target=\"_blank\">EPA 815-R-05-004 Supplement 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.10\u201311<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.7.1\u20136<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.2 and 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11 and 17.21<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.9<\/b> The system shall be able to define the collection details for registered samples or specimens, including container size and type, number of containers, collection date and time, temperature, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.10<\/b> The system should allow for the addition of observations and descriptions to registered samples in the form of free text.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.11<\/b> The system should support the creation of user-definable default sample registration preferences and\/or input screens.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.12<\/b> The system should allow for the recording of sample delivery details such as deliverer, location, and date and time for a preregistered sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.107\" target=\"_blank\">21 CFR Part 58.107 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.8.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual D-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.13<\/b> The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.107\" target=\"_blank\">21 CFR Part 58.107 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.14<\/b> The system shall provide a user-friendly means for tracking and acknowledging the physical reception of submitted sample or specimen material in the laboratory, including date and time of reception.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.15<\/b> The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1.3\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.16<\/b> The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.2 and 2.2.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.17<\/b> The system should provide a means to document sample preparation activities for a given sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D-9\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Appendix A<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.3\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.8\u20139<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.18<\/b> The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.16\" target=\"_blank\">7 CFR Part 331.16<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.16\" target=\"_blank\">9 CFR Part 121.16<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.16\" target=\"_blank\">42 CFR Part 73.16<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.19<\/b> In the case of regulated samples (e.g., select agent or toxin, cannabis, etc.), the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.20<\/b> The system shall be able to link various records together based on a record's metadata, including sample or specimen identifier, patient number, or family identifier.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"2._Sample_management\">2. Sample management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.1<\/b> The system shall record and maintain the chain of custody for the laboratory's standards and reagents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.2<\/b> The system shall record the current and historical storage location for the laboratory's standards and reagents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.3<\/b> The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.4<\/b> The system shall require the recording of a standard and reagent's first opening date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.5<\/b> The system shall allow only active standards and reagents to be shown as available for use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.6<\/b> The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.7<\/b> The system shall allow logically associated samples or specimens to be grouped together based on associated metadata such as type, test method, assigned user, and status.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.8<\/b> The system should allow for the accurate identification of a physical sample or specimen in the system via barcode or RFID technology.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.9<\/b> The system should provide a means to manually or automatically track sample or specimen inventory amounts and status.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.10<\/b> The system shall be able to link test methods and specifications to standards and reagents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1153 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.65\" target=\"_blank\">21 CFR Part 606.65 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.151\" target=\"_blank\">21 CFR Part 606.151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10\u201312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 12.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.22\u201325<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.11<\/b> The system shall allow samples, specimens, and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, remediated testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"3._Core_laboratory_testing_and_experiments\">3. Core laboratory testing and experiments<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>3.1<\/b> The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>3.2<\/b> The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.3<\/b> The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.4<\/b> The system shall be able to check physical, control, and specification limits for an instrument sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.5<\/b> The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.6<\/b> The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.7<\/b> The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.8<\/b> The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.9<\/b> The system shall support, at a minimum, the floating point\/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.10<\/b> The system shall allow users to enter operators such as <, >, +, and - with numeric test results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.11<\/b> The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-13<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.12<\/b> The system should effectively alert users upon entry of out-of-specification test results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1153 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (c\u2013f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.325<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.161<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.202<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.160\" target=\"_blank\">21 CFR Part 606.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G16.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.10<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.1.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.1\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section II.4.i<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>3.13<\/b> The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 1.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.14<\/b> The system shall allow users to link samples, specimens, and tests to a specific accreditation approval status (e.g., World Anti-Doping Agency accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"4._Results_review_and_verification\">4. Results review and verification<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.1<\/b> The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 1.2<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.2<\/b> The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.3<\/b> The system shall accurately maintain a full audit trail for modified results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-28\u201329<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G15.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.2\u20133 and 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.4<\/b> The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.5<\/b> The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.6<\/b> The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 4.0<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>4.7<\/b> The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span id=\"rdp-ebb-5._Sample,_experiment,_and_study_approval_and_verification\"><\/span><span class=\"mw-headline\" id=\"5._Sample.2C_experiment.2C_and_study_approval_and_verification\">5. Sample, experiment, and study approval and verification<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.9\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.12.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>5.1<\/b> The system shall accurately record details of a sample or specimen's final disposition.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>5.2<\/b> The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>5.3<\/b> The system should provide appropriate functions for specific sample statuses like \"approved\" and \"rejected,\" including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"6._Reporting\">6. Reporting<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.1<\/b> The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.12\u201315<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.2<\/b> The system shall be able to export data in a computer-readable (importable into a relational database) format\u2014such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file\u2014as well as PDF format, for reporting purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (g) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.3<\/b> The system shall alert stakeholders in advance to cases when the analyzed sample may be out-of-specification or may not meet expected turnaround time requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.4<\/b> The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., \"less than X mg\/L\") when doing so would provide relevant information to the report recipient.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.25\" target=\"_blank\">7 CFR Part 91.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (c\u2013e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.10.2\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-12 and -32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.43<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.5<\/b> The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.26\" target=\"_blank\">7 CFR Part 91.26\u201327<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.6<\/b> The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.7<\/b> The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, patient results, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.5\" target=\"_blank\">7 CFR Part 331.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.5\" target=\"_blank\">9 CFR Part 121.5\u20136<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.185\" target=\"_blank\">21 CFR Part 58.185<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.64\" target=\"_blank\">21 CFR Part 312.64<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.150\" target=\"_blank\">21 CFR Part 812.150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.31\" target=\"_blank\">40 CFR Part 141.31<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.721\" target=\"_blank\">40 CFR Part 141.721<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-370\/subpart-C\" target=\"_blank\">40 CFR Part 370 Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-372\/subpart-B\" target=\"_blank\">40 CFR Part 372 Subpart B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\" target=\"_blank\">40 CFR Part 704<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-717\/subpart-A\" target=\"_blank\">40 CFR Part 717 Subpart A<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/720.40\" target=\"_blank\">40 CFR Part 720.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.5\" target=\"_blank\">42 CFR Part 73.5\u20136<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C13.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories E8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G17.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.12\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 4, 2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 4, 1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-6 and IR-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.8<\/b> The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, analytical worksheets, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.28\" target=\"_blank\">7 CFR Part 91.28<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.185\" target=\"_blank\">21 CFR Part 58 Sec. 58.185 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.10.9\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.9<\/b> The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173540\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.057 seconds\nReal time usage: 0.060 seconds\nPreprocessor visited node count: 482\/1000000\nPost\u2010expand include size: 76839\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 11.378 1 -total\n 17.77% 2.022 1 Template:LIMSpec\/Sample_and_experiment_registration\n 15.99% 1.820 1 Template:LIMSpec\/Reporting\n 15.94% 1.813 1 Template:LIMSpec\/Results_review_and_verification\n 15.92% 1.811 1 Template:LIMSpec\/Sample_management\n 15.51% 1.765 1 Template:LIMSpec\/Core_laboratory_testing_and_experiments\n 14.69% 1.671 1 Template:LIMSpec\/Sample,_experiment,_and_study_approval_and_verification\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11179-0!canonical and timestamp 20221202173540 and revision id 36389. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#3._Core_laboratory_testing_and_experiments\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#3._Core_laboratory_testing_and_experiments<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","391eb403b8e74d30746c87a3dd134f66_images":[],"391eb403b8e74d30746c87a3dd134f66_timestamp":1670002540,"15457a38f6d575c440f33bcc732c18a2_type":"article","15457a38f6d575c440f33bcc732c18a2_title":"2. Sample management","15457a38f6d575c440f33bcc732c18a2_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#2._Sample_management","15457a38f6d575c440f33bcc732c18a2_plaintext":"\n\nLII:LIMSpec\/Primary Laboratory WorkflowFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the core of your typical laboratory workflow, from sample\/specimen receipt and sampling procedures, to analysis, review, and reporting.\n\n1. Sample and experiment registration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 1.1149\r\n\n42 CFR Part 493.1241\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 C-1-1\n\n\n1.1 The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.\n\n\n\n21 CFR Part 58.105 (c)\r\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.101\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 606.120 (b)\r\n\n21 CFR Part 606.121 (c\u2013i)\r\n\n21 CFR Part 606.140 (c)\r\n\n29 CFR Part 1910.1030 (g)\r\n\n29 CFR Part 1910.1096 (e1-6)\r\n\n42 CFR Part 493.1232\r\n\nABFT Accreditation Manual Sec. D\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1492-11 4.1.1.6\r\n\nASTM E1578-18 C-1-2\r\n\nCLSI QMS22 2.2.1.2\r\n\nEPA ERLN Laboratory Requirements 3.2.2\r\n\nEPA QA\/G-5 2.2.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 15\r\nOECD GLP Principles 6.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)\r\n\nUSDA Sampling Procedures for PDP 6.4.1.2.6\r\n\nWHO Technical Report Series, #986, Annex 2, 17.11\n\n\n1.2 The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.\n\n\n45 CFR Part 162.410\r\nCJIS Security Policy 5.6.1\n\n1.3 The system shall provide a means to assign unique identifiers such as a National Provider Identifier (NPI) or Originating Agency Identifier (ORI) to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.\n\n\n42 CFR Part 493.1241\r\nASTM E1578-18 C-1-3\n\n1.4 The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.\n\n\n\n7 CFR Part 91.19\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n40 CFR Part 262.18\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C2.1\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 C-1-4\r\n\nUSDA Sampling Procedures for PDP 6.4.1.1.3\n\n\n1.5 The system should permit unique metadata like lot number, patient number, family identifier, client or patient demographics, sampling point, random selection process used, and industry-specific items (like EPA identification number or U.S. Customs and Border Protection number) to be included during registration.\n\n\nASTM E1578-18 C-1-5\n\n1.6 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.\n\n\nASTM E1578-18 C-1-6\n\n1.7 The system should offer safety information related to a submitted sample upon registration that is relevant to the lab's location and industry.\n\n\nASTM E1578-18 C-1-7\n\n1.8 The system should support the creation and use of predefined metadata templates, as well as ad-hoc, single, and multiple samples.\n\n\n\n7 CFR Part 91.19\r\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 1.1149\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 58.105 (c)\r\n\n21 CFR Part 58.195\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.170\r\n\n21 CFR Part 211.194\r\n\n21 CFR Part 312.57 (d)\r\n\n40 CFR Part 141.33\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1105\r\n\n42 CFR Part 493.1241\r\n\n42 CFR Part 493.1242\r\n\n42 CFR Part 493.1274 (f)\r\n\n42 CFR Part 493.1283\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.2\u20133\r\n\nAAVLD Requirements for an AVMDL Sec. 5.7.1.2\r\n\nABFT Accreditation Manual Sec. D\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C2\r\n\nASTM E1578-18 C-1-8\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 6 and 8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8\r\n\nEPA 815-R-05-004 Supplement 1\r\n\nEPA ERLN Laboratory Requirements 3.2\r\n\nEPA ERLN Laboratory Requirements 4.4.10\u201311\r\n\nEPA ERLN Laboratory Requirements 4.7.1\u20136\r\n\nEPA QA\/G-5 2.2.2 and 2.2.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 11.4\r\n\nISO 15189:2012 5.7.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 6.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13\r\n\nUSDA Sampling Procedures for PDP 5.1\r\n\nWHO Technical Report Series, #986, Annex 2, 17.11 and 17.21\n\n\n1.9 The system shall be able to define the collection details for registered samples or specimens, including container size and type, number of containers, collection date and time, temperature, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.\n\n\n\nASTM E1578-18 C-1-9\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G1.4\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA ERLN Laboratory Requirements 3.2.1\r\n\nEPA ERLN Laboratory Requirements 4.4.5\n\n\n1.10 The system should allow for the addition of observations and descriptions to registered samples in the form of free text.\n\n\nASTM E1578-18 C-1-10\n\n1.11 The system should support the creation of user-definable default sample registration preferences and\/or input screens.\n\n\n\n21 CFR Part 1.1149\r\n\nASTM E1578-18 C-1-11\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7)\r\n\nWADA International Standard for Laboratories (ISL) 5.3.2\n\n\n1.12 The system should allow for the recording of sample delivery details such as deliverer, location, and date and time for a preregistered sample.\n\n\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 58.107 (c)\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1241\r\n\n42 CFR Part 493.1274\r\n\n42 CFR Part 493.1283\r\n\nAAVLD Requirements for an AVMDL Sec. 5.8.2\r\n\nABFT Accreditation Manual D-3\r\n\nASTM E1578-18 C-1-12\r\n\nCAP Laboratory Accreditation Manual\r\n\nEPA ERLN Laboratory Requirements 3.2.2\r\n\nEPA ERLN Laboratory Requirements 4.1.11\r\n\nEPA ERLN Laboratory Requirements 4.4.10\r\n\nEPA QA\/G-5 2.2.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 15\r\n\nISO\/IEC 17025:2017 7.4.2\r\n\nOECD GLP Principles 6.2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.1.11\r\n\nUSDA Sampling Procedures for PDP 6.4.1.2.5\r\n\nWADA International Standard for Laboratories (ISL) 5.3.2\r\n\nWHO Technical Report Series, #986, Annex 2, 17.11\n\n\n1.13 The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 58.107 (d)\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 73.17\r\n\nASTM E1578-18 C-1-13\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA ERLN Laboratory Requirements 4.4.7\r\n\nEPA QA\/G-5 2.2.3\r\n\nOECD GLP Principles 6.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3)\n\n\n1.14 The system shall provide a user-friendly means for tracking and acknowledging the physical reception of submitted sample or specimen material in the laboratory, including date and time of reception.\n\n\n\n21 CFR Part 1.1149\r\n\nASTM E1578-18 C-1-14\r\n\nEPA ERLN Laboratory Requirements 4.4.6\n\n\n1.15 The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.\n\n\n\nACMG Technical Standards for Clinical Genetics Laboratories C3.3\r\n\nAAVLD Requirements for an AVMDL Sec. 5.8.3\r\n\nASTM E1492-11 4.1.1.5\r\n\nASTM E1492-11 4.1.6\r\n\nASTM E1492-11 4.3.3.2\r\n\nASTM E1578-18 C-1-15\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA ERLN Laboratory Requirements 4.4.13\r\n\nEPA ERLN Laboratory Requirements 4.11.8\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.1.3\u20137\r\n\nUSDA Sampling Procedures for PDP 6.4.1.1.9\r\n\nWADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1\n\n\n1.16 The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.\n\n\n\n21 CFR Part 1.1149\r\n\nA2LA C211 5.7\r\n\nASTM E1578-18 C-1-16\r\n\nEPA QA\/G-5 2.2.2 and 2.2.3\n\n\n1.17 The system should provide a means to document sample preparation activities for a given sample.\n\n\n\n7 CFR Part 331.11\r\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.11\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 1.1149\r\n\n21 CFR Part 1.1152 (d)\r\n\n42 CFR Part 73.11\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1274\r\n\nA2LA C223 4.13\r\n\nA2LA C223 5.8\r\n\nABFT Accreditation Manual Sec. D-9\u201310\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1\r\n\nASTM E1492-11 (throughout)\r\n\nASTM E1578-18 C-1-17\r\n\nCLSI QMS22 2.2.3.5\r\n\nEPA 815-R-05-004 Chap. III, Sec. 12\r\n\nEPA 815-R-05-004 Appendix A\r\n\nEPA ERLN Laboratory Requirements 3.2.3\u20135\r\n\nEPA ERLN Laboratory Requirements 4.1.13\r\n\nEPA ERLN Laboratory Requirements 4.4.8\u20139\r\n\nEPA QA\/G-5 2.2.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)\r\n\nWADA International Standard for Laboratories (ISL) (throughout)\n\n\n1.18 The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.\n\n\n7 CFR Part 331.16\r\n9 CFR Part 121.16\r\n42 CFR Part 73.16\n\n1.19 In the case of regulated samples (e.g., select agent or toxin, cannabis, etc.), the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required information.\n\n\nACMG Technical Standards for Clinical Genetics Laboratories G1.1\r\nAPHL 2019 LIS Project Management Guidebook\n\n1.20 The system shall be able to link various records together based on a record's metadata, including sample or specimen identifier, patient number, or family identifier.\n\n\n\n2. Sample management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASTM E1578-18 C-2-1\r\n\nEPA ERLN Laboratory Requirements 4.11.14\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2\n\n\n2.1 The system shall record and maintain the chain of custody for the laboratory's standards and reagents.\n\n\nASTM E1578-18 C-2-2\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.2 The system shall record the current and historical storage location for the laboratory's standards and reagents.\n\n\nASTM E1578-18 C-2-3\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.3 The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.\n\n\nASTM E1578-18 C-2-4\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.4 The system shall require the recording of a standard and reagent's first opening date.\n\n\nASTM E1578-18 C-2-5\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.5 The system shall allow only active standards and reagents to be shown as available for use.\n\n\nASTM E1578-18 C-2-6\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.6 The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.\n\n\nASTM E1578-18 C-2-7\n\n2.7 The system shall allow logically associated samples or specimens to be grouped together based on associated metadata such as type, test method, assigned user, and status.\n\n\nASTM E1578-18 C-2-8\r\nEPA ERLN Laboratory Requirements 3.2\r\nISO\/IEC 17025:2017 7.4.2\n\n2.8 The system should allow for the accurate identification of a physical sample or specimen in the system via barcode or RFID technology.\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 211.84\r\n\n42 CFR Part 73.17\r\n\nASTM E1492-11 4.2.1\r\n\nASTM E1578-18 C-2-9\r\n\nCAP Laboratory Accreditation Manual\n\n\n2.9 The system should provide a means to manually or automatically track sample or specimen inventory amounts and status.\n\n\n\n21 CFR Part 1.1152 (d)\r\n\nA2LA C211 5.4\r\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1\r\nASTM E1578-18 C-2-10\n\n\n2.10 The system shall be able to link test methods and specifications to standards and reagents.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 1.1153 (c)\r\n\n21 CFR Part 111.315\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.166\u20137\r\n\n21 CFR Part 211.194 (e)\r\n\n21 CFR Part 212.40 (c)\r\n\n21 CFR Part 212.61\r\n\n21 CFR Part 212.70 (e)\r\n\n21 CFR Part 225.58\r\n\n21 CFR Part 226.58\r\n\n21 CFR Part 606.65 (c)\r\n\n21 CFR Part 606.151\r\n\nA2LA C223 5.9\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.2\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C10\u201312\r\n\nCAP Laboratory Accreditation Manual\r\n\nASTM E1578-18 C-2-11\r\n\nEPA ERLN Laboratory Requirements 3.1.2.1\r\n\nEPA ERLN Laboratory Requirements 4.3.2\r\n\nEPA ERLN Laboratory Requirements 4.11.3.2\r\n\nEPA QA\/G-5 2.2.5\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)\r\n\nUSDA Administrative Procedures for the PDP 8.5\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\nWADA International Standard for Laboratories (ISL) 5.3.7\r\n\nWHO Technical Report Series, #961, Annex 13, 12.1\r\n\nWHO Technical Report Series, #986, Annex 2, 17.7\r\n\nWHO Technical Report Series, #986, Annex 2, 17.22\u201325\n\n\n2.11 The system shall allow samples, specimens, and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, remediated testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.\n\n\n\n3. Core laboratory testing and experiments \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 111.315\r\n\n21 CFR Part 211.84 (d)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1\r\n\nASTM E1578-18 C-3-1\r\n\nCLSI QMS22 2.2.2.1\r\n\nISO 15189:2012 5.3.2.7\r\n\nWADA International Standard for Laboratories (ISL) 5.2.7\n\n\n3.1 The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.\n\n\n\n21 CFR Part 211.84 (e)\r\n\n42 CFR Part 493.1252 (d)\r\n\nASTM E1578-18 C-3-2\r\n\nWADA International Standard for Laboratories (ISL) 5.2.7\n\n\n3.2 The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.\n\n\n42 CFR Part 493.1252 (d)\r\nASTM E1578-18 C-3-3\n\n3.3 The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.\n\n\nASTM E1578-18 C-3-4\n\n3.4 The system shall be able to check physical, control, and specification limits for an instrument sample.\n\n\nASTM E1578-18 C-3-6\n\n3.5 The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.\n\n\nASTM E1578-18 C-3-7\n\n3.6 The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.\n\n\nASTM E1578-18 C-3-8\n\n3.7 The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.\n\n\nASTM E1578-18 C-3-9\n\n3.8 The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.\n\n\nASTM E1578-18 C-3-10\n\n3.9 The system shall support, at a minimum, the floating point\/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.\n\n\nAIHA-LAP Policies 2022 2A.7.8.2\r\nASTM E1578-18 C-3-11\n\n3.10 The system shall allow users to enter operators such as <, >, +, and - with numeric test results.\n\n\nASTM E1578-18 C-3-12\n\n3.11 The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.\n\n\n42 CFR Part 493.1241\r\nASTM E1578-18 C-3-13\r\nEPA ERLN Laboratory Requirements 4.9.11\n\n3.12 The system should effectively alert users upon entry of out-of-specification test results.\n\n\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 1.1153 (c)\r\n\n21 CFR Part 106.100 (c\u2013f)\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.325\r\n\n21 CFR Part 112.161\r\n\n21 CFR Part 114.100 (a)\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.194\r\n\n21 CFR Part 212.60 (g)\r\n\n21 CFR Part 507.202\r\n\n21 CFR Part 606.160\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G16.1\r\n\nA2LA C223 5.10\nASTM E1578-18 C-3-14\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.1\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCLSI QMS22 2.1.2\r\n\nCLSI QMS22 2.2.2.1\r\n\nEPA ERLN Laboratory Requirements 3.1.2.3\u20134\r\n\nEPA ERLN Laboratory Requirements 3.2\r\n\nEPA ERLN Laboratory Requirements 4.3.4\r\n\nEPA ERLN Laboratory Requirements 4.8.1\u20134\r\n\nEPA ERLN Laboratory Requirements 4.11.16\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section II.4.i\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c\r\n\nIFS Food 7, Part 2, 4.18.3\r\n\nIFS PACsecure 2, Part 2, 4.18.3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.4.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6\r\n\nUSDA Data and Instrumentation for PDP 5.4.2\r\n\nUSDA Data and Instrumentation for PDP 8.1.3\r\n\nWHO Technical Report Series, #986, Annex 2, 15.8\n\n\n3.13 The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.\n\n\nWADA International Standard for Laboratories (ISL) 1.2\n\n3.14 The system shall allow users to link samples, specimens, and tests to a specific accreditation approval status (e.g., World Anti-Doping Agency accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.\n\n\n\n4. Results review and verification \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 211.68 (b)\r\n\n42 CFR Part 493.1241\r\n\nASTM E1578-18 C-4-1\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.1.2\r\n\nEPA ERLN Laboratory Requirements 4.9.11\r\n\nEPA QA\/G-5 2.4.1\r\n\nISO 15189:2012 5.5.1.4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.\n\n\n\nASTM E1578-18 C-4-2\r\n\nCLSI AUTO15 1.2\nEPA ERLN Laboratory Requirements 4.9.2\r\n\nEPA ERLN Laboratory Requirements 4.9.11\r\n\nEPA QA\/G-5 2.4.1\r\n\nISO 15189:2012 5.9.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\n\n4.2 The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.\n\n\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 C-4-3\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCLSI QMS22 2.2.2.2\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nICH GCP 4.9.0 and 4.9.3\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12\n\n\n4.3 The system shall accurately maintain a full audit trail for modified results.\n\n\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 211.68 (b)\r\n\nA2LA C211 5.9.1\r\n\nA2LA C223 4.13\r\n\nABFT Accreditation Manual Sec. E-28\u201329\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G15.1\r\n\nAIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4\u20135\r\n\nASTM E1578-18 C-4-4\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.2.2\r\n\nEPA ERLN Laboratory Requirements 3.2.6\r\n\nEPA ERLN Laboratory Requirements 4.9.2\u20133 and 4.9.11\r\n\nEPA ERLN Laboratory Requirements 4.11.4\r\n\nEPA QA\/G-5 2.2.10\r\n\nEPA QA\/G-5 2.4.1\r\n\nE.U. Annex 11-6\r\n\nIFS Food 7, Part 2, 5.6.4\r\n\nIFS PACsecure 2, Part 2, 5.6.4\r\n\nISO 15189:2012 5.7.1\r\n\nISO\/IEC 17025:2017 7.8.1.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nUSDA Data and Instrumentation for PDP 10\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.1\r\n\nWHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1\n\n\n4.4 The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.\n\n\n\nASTM E1578-18 C-4-5\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nBRC GSFS, Issue 8, 5.6.2.5\r\n\nEPA ERLN Laboratory Requirements 4.9.11\r\n\nEPA QA\/G-5 2.2.10\r\n\nEPA QA\/G-5 2.4.1\r\n\nE.U. Annex 11-6\r\n\nIFS Food 7, Part 2, 5.6.4\r\n\nIFS PACsecure 2, Part 2, 5.6.4\r\n\nISO 15189:2012 5.9.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n4.5 The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.\n\n\n\nASTM E1578-18 C-4-6\r\n\nEPA QA\/G-5 2.2.10\r\n\nEPA QA\/G-5 2.4.1\r\n\nE.U. Annex 11-6\n\n\n4.6 The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.\n\n\nCAP Laboratory Accreditation Manual\r\nCLSI AUTO15 4.0\r\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n4.7 The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.\n\n\n\n 5. Sample, experiment, and study approval and verification \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASTM E1578-18 C-5-1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.3.5\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.9\u201310\r\n\nWADA International Standard for Laboratories (ISL) 5.3.12.1\n\n\n5.1 The system shall accurately record details of a sample or specimen's final disposition.\n\n\n\nAIHA-LAP Policies 2022 2A.7.7.2\r\n\nASTM E1578-18 C-5-2\r\n\nCLSI QMS22 2.2.2.2\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12\n\n\n5.2 The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.\n\n\n21 CFR Part 211.160 (b)\r\nASTM E1578-18 C-5-3\r\nEPA 815-R-05-004 Chap. IV, Sec. 6.1\n\n5.3 The system should provide appropriate functions for specific sample statuses like \"approved\" and \"rejected,\" including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.\n\n\n\n6. Reporting \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 C-6-1\n\n6.1 The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.\n\n\nEPA ERLN Laboratory Requirements 3.4\r\nEPA ERLN Laboratory Requirements 4.1.4\r\nEPA ERLN Laboratory Requirements 4.12\u201315\n\n6.2 The system shall be able to export data in a computer-readable (importable into a relational database) format\u2014such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file\u2014as well as PDF format, for reporting purposes.\n\n\n\n42 CFR Part 493.1291 (g) and (h)\r\n\nACMG Technical Standards for Clinical Genetics Laboratories F7.2\r\n\nASTM E1578-18 C-6-2\r\n\nCLSI QMS22 2.1.2.1\r\n\nEPA ERLN Laboratory Requirements 4.11.4\r\n\nEPA QA\/G-5 2.4.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n6.3 The system shall alert stakeholders in advance to cases when the analyzed sample may be out-of-specification or may not meet expected turnaround time requirements.\n\n\nABFT Accreditation Manual Sec. G-2\n\n6.4 The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., \"less than X mg\/L\") when doing so would provide relevant information to the report recipient.\n\n\n\n7 CFR Part 91.25\r\n\n21 CFR Part 1.1152 (d)\r\n\n40 CFR Part 141.33\r\n\n42 CFR Part 493.1291 (c\u2013e)\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.1\r\n\nAAVLD Requirements for an AVMDL Sec. 5.10.2\u20135\r\n\nAIHA-LAP Policies 2022 2A.7.8.1\r\n\nABFT Accreditation Manual Sec. E-12 and -32\r\n\nASTM E1578-18 C-6-3\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8\r\n\nISO 15189:2012 4.5.2\r\n\nISO 15189:2012 5.8.3\r\n\nISO\/IEC 17025:2017 7.5.1\r\n\nISO\/IEC 17025:2017 7.8.1.1\r\n\nISO\/IEC 17025:2017 7.8.2.1\r\n\nISO\/IEC 17025:2017 7.8.3.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d\r\n\nWHO Technical Report Series, #986, Annex 2, 15.43\n\n\n6.5 The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates.\n\n\n7 CFR Part 91.26\u201327\r\n21 CFR Part 1.1152 (d)\r\nASTM E1578-18 C-6-4\n\n6.6 The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.\n\n\n\nA2LA C211 5.10\r\n\nASTM E1578-18 C-6-5\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCLSI QMS22 2.2.3\r\n\nISO 15189:2012 5.8.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.4\n\n\n6.7 The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, patient results, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.\n\n\n\n7 CFR Part 331.5\r\n\n9 CFR Part 121.5\u20136\r\n\n21 CFR Part 1.1110\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n21 CFR Part 58.185\r\n\n21 CFR Part 312.64\r\n\n21 CFR Part 812.150\r\n\n40 CFR Part 141.31\r\n\n40 CFR Part 141.721\r\n\n40 CFR Part 370 Subpart C\r\n\n40 CFR Part 372 Subpart B\r\n\n40 CFR Part 704\r\n\n40 CFR Part 717 Subpart A\r\n\n40 CFR Part 720.40\r\n\n42 CFR Part 73.5\u20136\r\n\n42 CFR Part 493.43 (d)\r\n\nABFT Accreditation Manual Sec. E-7\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C13.3\r\n\nACMG Technical Standards for Clinical Genetics Laboratories E8\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G17.1\r\n\nASTM E1578-18 C-6-7\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.3.1\r\n\nEPA ERLN Laboratory Requirements 4.12\u201315\r\n\nEPA QA\/G-5 2.3.2\r\n\nIFS Food 7, Part 4, 2.x\r\n\nIFS PACsecure 2, Part 4, 1.x\r\n\nNIST 800-53, Rev. 5, IR-6 and IR-6(1)\r\n\nOECD GLP Principles 9.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.4\n\n\n6.8 The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, analytical worksheets, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.\n\n\n\n7 CFR Part 91.28\r\n\n21 CFR Part 1.1154 (c)\r\n\n21 CFR Part 58 Sec. 58.185 (c)\r\n\nA2LA C211 5.10.9\r\n\nAAVLD Requirements for an AVMDL Sec. 5.10.9\u201310\r\n\nCLSI QMS22 2.2.3.4\r\n\nICH GCP 4.9.3\r\n\nISO\/IEC 17025:2017 7.8.8\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 9.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)\r\n\n\n\n6.9 The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#2._Sample_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#2._Sample_management<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 20 September 2019, at 17:58.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2,200 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","15457a38f6d575c440f33bcc732c18a2_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Primary_Laboratory_Workflow rootpage-LII_LIMSpec_Primary_Laboratory_Workflow skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Primary Laboratory Workflow<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the core of your typical laboratory workflow, from sample\/specimen receipt and sampling procedures, to analysis, review, and reporting.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"1._Sample_and_experiment_registration\">1. Sample and experiment registration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.1<\/b> The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.121\" target=\"_blank\">21 CFR Part 606.121 (c\u2013i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.140\" target=\"_blank\">21 CFR Part 606.140 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e1-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 15<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.2<\/b> The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/162.410\" target=\"_blank\">45 CFR Part 162.410<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.3<\/b> The system shall provide a means to assign unique identifiers such as a National Provider Identifier (NPI) or Originating Agency Identifier (ORI) to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.4<\/b> The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.19\" target=\"_blank\">7 CFR Part 91.19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.18\" target=\"_blank\">40 CFR Part 262.18<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.5<\/b> The system should permit unique metadata like lot number, patient number, family identifier, client or patient demographics, sampling point, random selection process used, and industry-specific items (like EPA identification number or U.S. Customs and Border Protection number) to be included during registration.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.6<\/b> The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.7<\/b> The system should offer safety information related to a submitted sample upon registration that is relevant to the lab's location and industry.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.8<\/b> The system should support the creation and use of predefined metadata templates, as well as ad-hoc, single, and multiple samples.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.19\" target=\"_blank\">7 CFR Part 91.19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.195<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.170\" target=\"_blank\">21 CFR Part 211.170<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1105\" target=\"_blank\">42 CFR Part 493.1105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1242\" target=\"_blank\">42 CFR Part 493.1242<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.7.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6 and 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=P1000PUE.txt\" target=\"_blank\">EPA 815-R-05-004 Supplement 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.10\u201311<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.7.1\u20136<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.2 and 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11 and 17.21<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.9<\/b> The system shall be able to define the collection details for registered samples or specimens, including container size and type, number of containers, collection date and time, temperature, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.10<\/b> The system should allow for the addition of observations and descriptions to registered samples in the form of free text.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.11<\/b> The system should support the creation of user-definable default sample registration preferences and\/or input screens.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.12<\/b> The system should allow for the recording of sample delivery details such as deliverer, location, and date and time for a preregistered sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.107\" target=\"_blank\">21 CFR Part 58.107 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.8.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual D-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.13<\/b> The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.107\" target=\"_blank\">21 CFR Part 58.107 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.14<\/b> The system shall provide a user-friendly means for tracking and acknowledging the physical reception of submitted sample or specimen material in the laboratory, including date and time of reception.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.15<\/b> The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1.3\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.16<\/b> The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.2 and 2.2.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.17<\/b> The system should provide a means to document sample preparation activities for a given sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D-9\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Appendix A<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.3\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.8\u20139<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.18<\/b> The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.16\" target=\"_blank\">7 CFR Part 331.16<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.16\" target=\"_blank\">9 CFR Part 121.16<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.16\" target=\"_blank\">42 CFR Part 73.16<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.19<\/b> In the case of regulated samples (e.g., select agent or toxin, cannabis, etc.), the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.20<\/b> The system shall be able to link various records together based on a record's metadata, including sample or specimen identifier, patient number, or family identifier.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"2._Sample_management\">2. Sample management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.1<\/b> The system shall record and maintain the chain of custody for the laboratory's standards and reagents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.2<\/b> The system shall record the current and historical storage location for the laboratory's standards and reagents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.3<\/b> The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.4<\/b> The system shall require the recording of a standard and reagent's first opening date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.5<\/b> The system shall allow only active standards and reagents to be shown as available for use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.6<\/b> The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.7<\/b> The system shall allow logically associated samples or specimens to be grouped together based on associated metadata such as type, test method, assigned user, and status.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.8<\/b> The system should allow for the accurate identification of a physical sample or specimen in the system via barcode or RFID technology.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.9<\/b> The system should provide a means to manually or automatically track sample or specimen inventory amounts and status.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.10<\/b> The system shall be able to link test methods and specifications to standards and reagents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1153 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.65\" target=\"_blank\">21 CFR Part 606.65 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.151\" target=\"_blank\">21 CFR Part 606.151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10\u201312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 12.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.22\u201325<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.11<\/b> The system shall allow samples, specimens, and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, remediated testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"3._Core_laboratory_testing_and_experiments\">3. Core laboratory testing and experiments<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>3.1<\/b> The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>3.2<\/b> The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.3<\/b> The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.4<\/b> The system shall be able to check physical, control, and specification limits for an instrument sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.5<\/b> The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.6<\/b> The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.7<\/b> The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.8<\/b> The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.9<\/b> The system shall support, at a minimum, the floating point\/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.10<\/b> The system shall allow users to enter operators such as <, >, +, and - with numeric test results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.11<\/b> The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-13<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.12<\/b> The system should effectively alert users upon entry of out-of-specification test results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1153 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (c\u2013f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.325<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.161<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.202<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.160\" target=\"_blank\">21 CFR Part 606.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G16.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.10<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.1.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.1\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section II.4.i<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>3.13<\/b> The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 1.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.14<\/b> The system shall allow users to link samples, specimens, and tests to a specific accreditation approval status (e.g., World Anti-Doping Agency accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"4._Results_review_and_verification\">4. Results review and verification<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.1<\/b> The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 1.2<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.2<\/b> The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.3<\/b> The system shall accurately maintain a full audit trail for modified results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-28\u201329<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G15.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.2\u20133 and 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.4<\/b> The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.5<\/b> The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.6<\/b> The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 4.0<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>4.7<\/b> The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span id=\"rdp-ebb-5._Sample,_experiment,_and_study_approval_and_verification\"><\/span><span class=\"mw-headline\" id=\"5._Sample.2C_experiment.2C_and_study_approval_and_verification\">5. Sample, experiment, and study approval and verification<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.9\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.12.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>5.1<\/b> The system shall accurately record details of a sample or specimen's final disposition.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>5.2<\/b> The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>5.3<\/b> The system should provide appropriate functions for specific sample statuses like \"approved\" and \"rejected,\" including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"6._Reporting\">6. Reporting<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.1<\/b> The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.12\u201315<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.2<\/b> The system shall be able to export data in a computer-readable (importable into a relational database) format\u2014such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file\u2014as well as PDF format, for reporting purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (g) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.3<\/b> The system shall alert stakeholders in advance to cases when the analyzed sample may be out-of-specification or may not meet expected turnaround time requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.4<\/b> The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., \"less than X mg\/L\") when doing so would provide relevant information to the report recipient.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.25\" target=\"_blank\">7 CFR Part 91.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (c\u2013e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.10.2\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-12 and -32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.43<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.5<\/b> The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.26\" target=\"_blank\">7 CFR Part 91.26\u201327<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.6<\/b> The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.7<\/b> The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, patient results, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.5\" target=\"_blank\">7 CFR Part 331.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.5\" target=\"_blank\">9 CFR Part 121.5\u20136<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.185\" target=\"_blank\">21 CFR Part 58.185<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.64\" target=\"_blank\">21 CFR Part 312.64<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.150\" target=\"_blank\">21 CFR Part 812.150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.31\" target=\"_blank\">40 CFR Part 141.31<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.721\" target=\"_blank\">40 CFR Part 141.721<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-370\/subpart-C\" target=\"_blank\">40 CFR Part 370 Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-372\/subpart-B\" target=\"_blank\">40 CFR Part 372 Subpart B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\" target=\"_blank\">40 CFR Part 704<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-717\/subpart-A\" target=\"_blank\">40 CFR Part 717 Subpart A<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/720.40\" target=\"_blank\">40 CFR Part 720.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.5\" target=\"_blank\">42 CFR Part 73.5\u20136<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C13.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories E8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G17.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.12\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 4, 2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 4, 1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-6 and IR-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.8<\/b> The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, analytical worksheets, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.28\" target=\"_blank\">7 CFR Part 91.28<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.185\" target=\"_blank\">21 CFR Part 58 Sec. 58.185 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.10.9\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.9<\/b> The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173540\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.057 seconds\nReal time usage: 0.060 seconds\nPreprocessor visited node count: 482\/1000000\nPost\u2010expand include size: 76839\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 11.378 1 -total\n 17.77% 2.022 1 Template:LIMSpec\/Sample_and_experiment_registration\n 15.99% 1.820 1 Template:LIMSpec\/Reporting\n 15.94% 1.813 1 Template:LIMSpec\/Results_review_and_verification\n 15.92% 1.811 1 Template:LIMSpec\/Sample_management\n 15.51% 1.765 1 Template:LIMSpec\/Core_laboratory_testing_and_experiments\n 14.69% 1.671 1 Template:LIMSpec\/Sample,_experiment,_and_study_approval_and_verification\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11179-0!canonical and timestamp 20221202173540 and revision id 36389. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#2._Sample_management\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#2._Sample_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","15457a38f6d575c440f33bcc732c18a2_images":[],"15457a38f6d575c440f33bcc732c18a2_timestamp":1670002540,"61aff0fab36cdf9b9d726a3caf608cc1_type":"article","61aff0fab36cdf9b9d726a3caf608cc1_title":"1. Sample and experiment registration","61aff0fab36cdf9b9d726a3caf608cc1_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#1._Sample_and_experiment_registration","61aff0fab36cdf9b9d726a3caf608cc1_plaintext":"\n\nLII:LIMSpec\/Primary Laboratory WorkflowFrom LIMSWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the core of your typical laboratory workflow, from sample\/specimen receipt and sampling procedures, to analysis, review, and reporting.\n\n1. Sample and experiment registration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 1.1149\r\n\n42 CFR Part 493.1241\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 C-1-1\n\n\n1.1 The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.\n\n\n\n21 CFR Part 58.105 (c)\r\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.101\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 606.120 (b)\r\n\n21 CFR Part 606.121 (c\u2013i)\r\n\n21 CFR Part 606.140 (c)\r\n\n29 CFR Part 1910.1030 (g)\r\n\n29 CFR Part 1910.1096 (e1-6)\r\n\n42 CFR Part 493.1232\r\n\nABFT Accreditation Manual Sec. D\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1492-11 4.1.1.6\r\n\nASTM E1578-18 C-1-2\r\n\nCLSI QMS22 2.2.1.2\r\n\nEPA ERLN Laboratory Requirements 3.2.2\r\n\nEPA QA\/G-5 2.2.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 15\r\nOECD GLP Principles 6.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)\r\n\nUSDA Sampling Procedures for PDP 6.4.1.2.6\r\n\nWHO Technical Report Series, #986, Annex 2, 17.11\n\n\n1.2 The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.\n\n\n45 CFR Part 162.410\r\nCJIS Security Policy 5.6.1\n\n1.3 The system shall provide a means to assign unique identifiers such as a National Provider Identifier (NPI) or Originating Agency Identifier (ORI) to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.\n\n\n42 CFR Part 493.1241\r\nASTM E1578-18 C-1-3\n\n1.4 The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.\n\n\n\n7 CFR Part 91.19\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n40 CFR Part 262.18\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C2.1\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 C-1-4\r\n\nUSDA Sampling Procedures for PDP 6.4.1.1.3\n\n\n1.5 The system should permit unique metadata like lot number, patient number, family identifier, client or patient demographics, sampling point, random selection process used, and industry-specific items (like EPA identification number or U.S. Customs and Border Protection number) to be included during registration.\n\n\nASTM E1578-18 C-1-5\n\n1.6 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.\n\n\nASTM E1578-18 C-1-6\n\n1.7 The system should offer safety information related to a submitted sample upon registration that is relevant to the lab's location and industry.\n\n\nASTM E1578-18 C-1-7\n\n1.8 The system should support the creation and use of predefined metadata templates, as well as ad-hoc, single, and multiple samples.\n\n\n\n7 CFR Part 91.19\r\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 1.1149\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 58.105 (c)\r\n\n21 CFR Part 58.195\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.170\r\n\n21 CFR Part 211.194\r\n\n21 CFR Part 312.57 (d)\r\n\n40 CFR Part 141.33\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1105\r\n\n42 CFR Part 493.1241\r\n\n42 CFR Part 493.1242\r\n\n42 CFR Part 493.1274 (f)\r\n\n42 CFR Part 493.1283\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.2\u20133\r\n\nAAVLD Requirements for an AVMDL Sec. 5.7.1.2\r\n\nABFT Accreditation Manual Sec. D\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C2\r\n\nASTM E1578-18 C-1-8\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 6 and 8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8\r\n\nEPA 815-R-05-004 Supplement 1\r\n\nEPA ERLN Laboratory Requirements 3.2\r\n\nEPA ERLN Laboratory Requirements 4.4.10\u201311\r\n\nEPA ERLN Laboratory Requirements 4.7.1\u20136\r\n\nEPA QA\/G-5 2.2.2 and 2.2.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 11.4\r\n\nISO 15189:2012 5.7.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 6.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13\r\n\nUSDA Sampling Procedures for PDP 5.1\r\n\nWHO Technical Report Series, #986, Annex 2, 17.11 and 17.21\n\n\n1.9 The system shall be able to define the collection details for registered samples or specimens, including container size and type, number of containers, collection date and time, temperature, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.\n\n\n\nASTM E1578-18 C-1-9\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G1.4\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA ERLN Laboratory Requirements 3.2.1\r\n\nEPA ERLN Laboratory Requirements 4.4.5\n\n\n1.10 The system should allow for the addition of observations and descriptions to registered samples in the form of free text.\n\n\nASTM E1578-18 C-1-10\n\n1.11 The system should support the creation of user-definable default sample registration preferences and\/or input screens.\n\n\n\n21 CFR Part 1.1149\r\n\nASTM E1578-18 C-1-11\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7)\r\n\nWADA International Standard for Laboratories (ISL) 5.3.2\n\n\n1.12 The system should allow for the recording of sample delivery details such as deliverer, location, and date and time for a preregistered sample.\n\n\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 58.107 (c)\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1241\r\n\n42 CFR Part 493.1274\r\n\n42 CFR Part 493.1283\r\n\nAAVLD Requirements for an AVMDL Sec. 5.8.2\r\n\nABFT Accreditation Manual D-3\r\n\nASTM E1578-18 C-1-12\r\n\nCAP Laboratory Accreditation Manual\r\n\nEPA ERLN Laboratory Requirements 3.2.2\r\n\nEPA ERLN Laboratory Requirements 4.1.11\r\n\nEPA ERLN Laboratory Requirements 4.4.10\r\n\nEPA QA\/G-5 2.2.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 15\r\n\nISO\/IEC 17025:2017 7.4.2\r\n\nOECD GLP Principles 6.2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.1.11\r\n\nUSDA Sampling Procedures for PDP 6.4.1.2.5\r\n\nWADA International Standard for Laboratories (ISL) 5.3.2\r\n\nWHO Technical Report Series, #986, Annex 2, 17.11\n\n\n1.13 The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 58.107 (d)\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 73.17\r\n\nASTM E1578-18 C-1-13\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA ERLN Laboratory Requirements 4.4.7\r\n\nEPA QA\/G-5 2.2.3\r\n\nOECD GLP Principles 6.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3)\n\n\n1.14 The system shall provide a user-friendly means for tracking and acknowledging the physical reception of submitted sample or specimen material in the laboratory, including date and time of reception.\n\n\n\n21 CFR Part 1.1149\r\n\nASTM E1578-18 C-1-14\r\n\nEPA ERLN Laboratory Requirements 4.4.6\n\n\n1.15 The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.\n\n\n\nACMG Technical Standards for Clinical Genetics Laboratories C3.3\r\n\nAAVLD Requirements for an AVMDL Sec. 5.8.3\r\n\nASTM E1492-11 4.1.1.5\r\n\nASTM E1492-11 4.1.6\r\n\nASTM E1492-11 4.3.3.2\r\n\nASTM E1578-18 C-1-15\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA ERLN Laboratory Requirements 4.4.13\r\n\nEPA ERLN Laboratory Requirements 4.11.8\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.1.3\u20137\r\n\nUSDA Sampling Procedures for PDP 6.4.1.1.9\r\n\nWADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1\n\n\n1.16 The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.\n\n\n\n21 CFR Part 1.1149\r\n\nA2LA C211 5.7\r\n\nASTM E1578-18 C-1-16\r\n\nEPA QA\/G-5 2.2.2 and 2.2.3\n\n\n1.17 The system should provide a means to document sample preparation activities for a given sample.\n\n\n\n7 CFR Part 331.11\r\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.11\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 1.1149\r\n\n21 CFR Part 1.1152 (d)\r\n\n42 CFR Part 73.11\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1274\r\n\nA2LA C223 4.13\r\n\nA2LA C223 5.8\r\n\nABFT Accreditation Manual Sec. D-9\u201310\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1\r\n\nASTM E1492-11 (throughout)\r\n\nASTM E1578-18 C-1-17\r\n\nCLSI QMS22 2.2.3.5\r\n\nEPA 815-R-05-004 Chap. III, Sec. 12\r\n\nEPA 815-R-05-004 Appendix A\r\n\nEPA ERLN Laboratory Requirements 3.2.3\u20135\r\n\nEPA ERLN Laboratory Requirements 4.1.13\r\n\nEPA ERLN Laboratory Requirements 4.4.8\u20139\r\n\nEPA QA\/G-5 2.2.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)\r\n\nWADA International Standard for Laboratories (ISL) (throughout)\n\n\n1.18 The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.\n\n\n7 CFR Part 331.16\r\n9 CFR Part 121.16\r\n42 CFR Part 73.16\n\n1.19 In the case of regulated samples (e.g., select agent or toxin, cannabis, etc.), the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required information.\n\n\nACMG Technical Standards for Clinical Genetics Laboratories G1.1\r\nAPHL 2019 LIS Project Management Guidebook\n\n1.20 The system shall be able to link various records together based on a record's metadata, including sample or specimen identifier, patient number, or family identifier.\n\n\n\n2. Sample management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASTM E1578-18 C-2-1\r\n\nEPA ERLN Laboratory Requirements 4.11.14\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2\n\n\n2.1 The system shall record and maintain the chain of custody for the laboratory's standards and reagents.\n\n\nASTM E1578-18 C-2-2\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.2 The system shall record the current and historical storage location for the laboratory's standards and reagents.\n\n\nASTM E1578-18 C-2-3\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.3 The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.\n\n\nASTM E1578-18 C-2-4\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.4 The system shall require the recording of a standard and reagent's first opening date.\n\n\nASTM E1578-18 C-2-5\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.5 The system shall allow only active standards and reagents to be shown as available for use.\n\n\nASTM E1578-18 C-2-6\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.6 The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.\n\n\nASTM E1578-18 C-2-7\n\n2.7 The system shall allow logically associated samples or specimens to be grouped together based on associated metadata such as type, test method, assigned user, and status.\n\n\nASTM E1578-18 C-2-8\r\nEPA ERLN Laboratory Requirements 3.2\r\nISO\/IEC 17025:2017 7.4.2\n\n2.8 The system should allow for the accurate identification of a physical sample or specimen in the system via barcode or RFID technology.\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 211.84\r\n\n42 CFR Part 73.17\r\n\nASTM E1492-11 4.2.1\r\n\nASTM E1578-18 C-2-9\r\n\nCAP Laboratory Accreditation Manual\n\n\n2.9 The system should provide a means to manually or automatically track sample or specimen inventory amounts and status.\n\n\n\n21 CFR Part 1.1152 (d)\r\n\nA2LA C211 5.4\r\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1\r\nASTM E1578-18 C-2-10\n\n\n2.10 The system shall be able to link test methods and specifications to standards and reagents.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 1.1153 (c)\r\n\n21 CFR Part 111.315\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.166\u20137\r\n\n21 CFR Part 211.194 (e)\r\n\n21 CFR Part 212.40 (c)\r\n\n21 CFR Part 212.61\r\n\n21 CFR Part 212.70 (e)\r\n\n21 CFR Part 225.58\r\n\n21 CFR Part 226.58\r\n\n21 CFR Part 606.65 (c)\r\n\n21 CFR Part 606.151\r\n\nA2LA C223 5.9\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.2\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C10\u201312\r\n\nCAP Laboratory Accreditation Manual\r\n\nASTM E1578-18 C-2-11\r\n\nEPA ERLN Laboratory Requirements 3.1.2.1\r\n\nEPA ERLN Laboratory Requirements 4.3.2\r\n\nEPA ERLN Laboratory Requirements 4.11.3.2\r\n\nEPA QA\/G-5 2.2.5\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)\r\n\nUSDA Administrative Procedures for the PDP 8.5\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\nWADA International Standard for Laboratories (ISL) 5.3.7\r\n\nWHO Technical Report Series, #961, Annex 13, 12.1\r\n\nWHO Technical Report Series, #986, Annex 2, 17.7\r\n\nWHO Technical Report Series, #986, Annex 2, 17.22\u201325\n\n\n2.11 The system shall allow samples, specimens, and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, remediated testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.\n\n\n\n3. Core laboratory testing and experiments \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 111.315\r\n\n21 CFR Part 211.84 (d)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1\r\n\nASTM E1578-18 C-3-1\r\n\nCLSI QMS22 2.2.2.1\r\n\nISO 15189:2012 5.3.2.7\r\n\nWADA International Standard for Laboratories (ISL) 5.2.7\n\n\n3.1 The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.\n\n\n\n21 CFR Part 211.84 (e)\r\n\n42 CFR Part 493.1252 (d)\r\n\nASTM E1578-18 C-3-2\r\n\nWADA International Standard for Laboratories (ISL) 5.2.7\n\n\n3.2 The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.\n\n\n42 CFR Part 493.1252 (d)\r\nASTM E1578-18 C-3-3\n\n3.3 The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.\n\n\nASTM E1578-18 C-3-4\n\n3.4 The system shall be able to check physical, control, and specification limits for an instrument sample.\n\n\nASTM E1578-18 C-3-6\n\n3.5 The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.\n\n\nASTM E1578-18 C-3-7\n\n3.6 The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.\n\n\nASTM E1578-18 C-3-8\n\n3.7 The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.\n\n\nASTM E1578-18 C-3-9\n\n3.8 The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.\n\n\nASTM E1578-18 C-3-10\n\n3.9 The system shall support, at a minimum, the floating point\/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.\n\n\nAIHA-LAP Policies 2022 2A.7.8.2\r\nASTM E1578-18 C-3-11\n\n3.10 The system shall allow users to enter operators such as <, >, +, and - with numeric test results.\n\n\nASTM E1578-18 C-3-12\n\n3.11 The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.\n\n\n42 CFR Part 493.1241\r\nASTM E1578-18 C-3-13\r\nEPA ERLN Laboratory Requirements 4.9.11\n\n3.12 The system should effectively alert users upon entry of out-of-specification test results.\n\n\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 1.1153 (c)\r\n\n21 CFR Part 106.100 (c\u2013f)\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.325\r\n\n21 CFR Part 112.161\r\n\n21 CFR Part 114.100 (a)\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.194\r\n\n21 CFR Part 212.60 (g)\r\n\n21 CFR Part 507.202\r\n\n21 CFR Part 606.160\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G16.1\r\n\nA2LA C223 5.10\nASTM E1578-18 C-3-14\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.1\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCLSI QMS22 2.1.2\r\n\nCLSI QMS22 2.2.2.1\r\n\nEPA ERLN Laboratory Requirements 3.1.2.3\u20134\r\n\nEPA ERLN Laboratory Requirements 3.2\r\n\nEPA ERLN Laboratory Requirements 4.3.4\r\n\nEPA ERLN Laboratory Requirements 4.8.1\u20134\r\n\nEPA ERLN Laboratory Requirements 4.11.16\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section II.4.i\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c\r\n\nIFS Food 7, Part 2, 4.18.3\r\n\nIFS PACsecure 2, Part 2, 4.18.3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.4.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6\r\n\nUSDA Data and Instrumentation for PDP 5.4.2\r\n\nUSDA Data and Instrumentation for PDP 8.1.3\r\n\nWHO Technical Report Series, #986, Annex 2, 15.8\n\n\n3.13 The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.\n\n\nWADA International Standard for Laboratories (ISL) 1.2\n\n3.14 The system shall allow users to link samples, specimens, and tests to a specific accreditation approval status (e.g., World Anti-Doping Agency accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.\n\n\n\n4. Results review and verification \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 211.68 (b)\r\n\n42 CFR Part 493.1241\r\n\nASTM E1578-18 C-4-1\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.1.2\r\n\nEPA ERLN Laboratory Requirements 4.9.11\r\n\nEPA QA\/G-5 2.4.1\r\n\nISO 15189:2012 5.5.1.4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.\n\n\n\nASTM E1578-18 C-4-2\r\n\nCLSI AUTO15 1.2\nEPA ERLN Laboratory Requirements 4.9.2\r\n\nEPA ERLN Laboratory Requirements 4.9.11\r\n\nEPA QA\/G-5 2.4.1\r\n\nISO 15189:2012 5.9.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\n\n4.2 The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.\n\n\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 C-4-3\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCLSI QMS22 2.2.2.2\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nICH GCP 4.9.0 and 4.9.3\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12\n\n\n4.3 The system shall accurately maintain a full audit trail for modified results.\n\n\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 211.68 (b)\r\n\nA2LA C211 5.9.1\r\n\nA2LA C223 4.13\r\n\nABFT Accreditation Manual Sec. E-28\u201329\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G15.1\r\n\nAIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4\u20135\r\n\nASTM E1578-18 C-4-4\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.2.2\r\n\nEPA ERLN Laboratory Requirements 3.2.6\r\n\nEPA ERLN Laboratory Requirements 4.9.2\u20133 and 4.9.11\r\n\nEPA ERLN Laboratory Requirements 4.11.4\r\n\nEPA QA\/G-5 2.2.10\r\n\nEPA QA\/G-5 2.4.1\r\n\nE.U. Annex 11-6\r\n\nIFS Food 7, Part 2, 5.6.4\r\n\nIFS PACsecure 2, Part 2, 5.6.4\r\n\nISO 15189:2012 5.7.1\r\n\nISO\/IEC 17025:2017 7.8.1.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nUSDA Data and Instrumentation for PDP 10\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.1\r\n\nWHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1\n\n\n4.4 The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.\n\n\n\nASTM E1578-18 C-4-5\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nBRC GSFS, Issue 8, 5.6.2.5\r\n\nEPA ERLN Laboratory Requirements 4.9.11\r\n\nEPA QA\/G-5 2.2.10\r\n\nEPA QA\/G-5 2.4.1\r\n\nE.U. Annex 11-6\r\n\nIFS Food 7, Part 2, 5.6.4\r\n\nIFS PACsecure 2, Part 2, 5.6.4\r\n\nISO 15189:2012 5.9.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n4.5 The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.\n\n\n\nASTM E1578-18 C-4-6\r\n\nEPA QA\/G-5 2.2.10\r\n\nEPA QA\/G-5 2.4.1\r\n\nE.U. Annex 11-6\n\n\n4.6 The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.\n\n\nCAP Laboratory Accreditation Manual\r\nCLSI AUTO15 4.0\r\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n4.7 The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.\n\n\n\n 5. Sample, experiment, and study approval and verification \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASTM E1578-18 C-5-1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.3.5\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.9\u201310\r\n\nWADA International Standard for Laboratories (ISL) 5.3.12.1\n\n\n5.1 The system shall accurately record details of a sample or specimen's final disposition.\n\n\n\nAIHA-LAP Policies 2022 2A.7.7.2\r\n\nASTM E1578-18 C-5-2\r\n\nCLSI QMS22 2.2.2.2\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12\n\n\n5.2 The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.\n\n\n21 CFR Part 211.160 (b)\r\nASTM E1578-18 C-5-3\r\nEPA 815-R-05-004 Chap. IV, Sec. 6.1\n\n5.3 The system should provide appropriate functions for specific sample statuses like \"approved\" and \"rejected,\" including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.\n\n\n\n6. Reporting \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 C-6-1\n\n6.1 The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.\n\n\nEPA ERLN Laboratory Requirements 3.4\r\nEPA ERLN Laboratory Requirements 4.1.4\r\nEPA ERLN Laboratory Requirements 4.12\u201315\n\n6.2 The system shall be able to export data in a computer-readable (importable into a relational database) format\u2014such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file\u2014as well as PDF format, for reporting purposes.\n\n\n\n42 CFR Part 493.1291 (g) and (h)\r\n\nACMG Technical Standards for Clinical Genetics Laboratories F7.2\r\n\nASTM E1578-18 C-6-2\r\n\nCLSI QMS22 2.1.2.1\r\n\nEPA ERLN Laboratory Requirements 4.11.4\r\n\nEPA QA\/G-5 2.4.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n6.3 The system shall alert stakeholders in advance to cases when the analyzed sample may be out-of-specification or may not meet expected turnaround time requirements.\n\n\nABFT Accreditation Manual Sec. G-2\n\n6.4 The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., \"less than X mg\/L\") when doing so would provide relevant information to the report recipient.\n\n\n\n7 CFR Part 91.25\r\n\n21 CFR Part 1.1152 (d)\r\n\n40 CFR Part 141.33\r\n\n42 CFR Part 493.1291 (c\u2013e)\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.1\r\n\nAAVLD Requirements for an AVMDL Sec. 5.10.2\u20135\r\n\nAIHA-LAP Policies 2022 2A.7.8.1\r\n\nABFT Accreditation Manual Sec. E-12 and -32\r\n\nASTM E1578-18 C-6-3\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8\r\n\nISO 15189:2012 4.5.2\r\n\nISO 15189:2012 5.8.3\r\n\nISO\/IEC 17025:2017 7.5.1\r\n\nISO\/IEC 17025:2017 7.8.1.1\r\n\nISO\/IEC 17025:2017 7.8.2.1\r\n\nISO\/IEC 17025:2017 7.8.3.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d\r\n\nWHO Technical Report Series, #986, Annex 2, 15.43\n\n\n6.5 The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates.\n\n\n7 CFR Part 91.26\u201327\r\n21 CFR Part 1.1152 (d)\r\nASTM E1578-18 C-6-4\n\n6.6 The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.\n\n\n\nA2LA C211 5.10\r\n\nASTM E1578-18 C-6-5\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCLSI QMS22 2.2.3\r\n\nISO 15189:2012 5.8.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.4\n\n\n6.7 The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, patient results, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.\n\n\n\n7 CFR Part 331.5\r\n\n9 CFR Part 121.5\u20136\r\n\n21 CFR Part 1.1110\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n21 CFR Part 58.185\r\n\n21 CFR Part 312.64\r\n\n21 CFR Part 812.150\r\n\n40 CFR Part 141.31\r\n\n40 CFR Part 141.721\r\n\n40 CFR Part 370 Subpart C\r\n\n40 CFR Part 372 Subpart B\r\n\n40 CFR Part 704\r\n\n40 CFR Part 717 Subpart A\r\n\n40 CFR Part 720.40\r\n\n42 CFR Part 73.5\u20136\r\n\n42 CFR Part 493.43 (d)\r\n\nABFT Accreditation Manual Sec. E-7\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C13.3\r\n\nACMG Technical Standards for Clinical Genetics Laboratories E8\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G17.1\r\n\nASTM E1578-18 C-6-7\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.3.1\r\n\nEPA ERLN Laboratory Requirements 4.12\u201315\r\n\nEPA QA\/G-5 2.3.2\r\n\nIFS Food 7, Part 4, 2.x\r\n\nIFS PACsecure 2, Part 4, 1.x\r\n\nNIST 800-53, Rev. 5, IR-6 and IR-6(1)\r\n\nOECD GLP Principles 9.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.4\n\n\n6.8 The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, analytical worksheets, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.\n\n\n\n7 CFR Part 91.28\r\n\n21 CFR Part 1.1154 (c)\r\n\n21 CFR Part 58 Sec. 58.185 (c)\r\n\nA2LA C211 5.10.9\r\n\nAAVLD Requirements for an AVMDL Sec. 5.10.9\u201310\r\n\nCLSI QMS22 2.2.3.4\r\n\nICH GCP 4.9.3\r\n\nISO\/IEC 17025:2017 7.8.8\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 9.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)\r\n\n\n\n6.9 The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#1._Sample_and_experiment_registration\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#1._Sample_and_experiment_registration<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 20 September 2019, at 17:58.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2,200 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","61aff0fab36cdf9b9d726a3caf608cc1_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Primary_Laboratory_Workflow rootpage-LII_LIMSpec_Primary_Laboratory_Workflow skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Primary Laboratory Workflow<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the core of your typical laboratory workflow, from sample\/specimen receipt and sampling procedures, to analysis, review, and reporting.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"1._Sample_and_experiment_registration\">1. Sample and experiment registration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.1<\/b> The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.121\" target=\"_blank\">21 CFR Part 606.121 (c\u2013i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.140\" target=\"_blank\">21 CFR Part 606.140 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e1-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 15<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.2<\/b> The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/162.410\" target=\"_blank\">45 CFR Part 162.410<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.3<\/b> The system shall provide a means to assign unique identifiers such as a National Provider Identifier (NPI) or Originating Agency Identifier (ORI) to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.4<\/b> The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.19\" target=\"_blank\">7 CFR Part 91.19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.18\" target=\"_blank\">40 CFR Part 262.18<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.5<\/b> The system should permit unique metadata like lot number, patient number, family identifier, client or patient demographics, sampling point, random selection process used, and industry-specific items (like EPA identification number or U.S. Customs and Border Protection number) to be included during registration.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.6<\/b> The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.7<\/b> The system should offer safety information related to a submitted sample upon registration that is relevant to the lab's location and industry.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.8<\/b> The system should support the creation and use of predefined metadata templates, as well as ad-hoc, single, and multiple samples.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.19\" target=\"_blank\">7 CFR Part 91.19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.195<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.170\" target=\"_blank\">21 CFR Part 211.170<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1105\" target=\"_blank\">42 CFR Part 493.1105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1242\" target=\"_blank\">42 CFR Part 493.1242<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.7.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6 and 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=P1000PUE.txt\" target=\"_blank\">EPA 815-R-05-004 Supplement 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.10\u201311<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.7.1\u20136<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.2 and 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11 and 17.21<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.9<\/b> The system shall be able to define the collection details for registered samples or specimens, including container size and type, number of containers, collection date and time, temperature, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.10<\/b> The system should allow for the addition of observations and descriptions to registered samples in the form of free text.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.11<\/b> The system should support the creation of user-definable default sample registration preferences and\/or input screens.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.12<\/b> The system should allow for the recording of sample delivery details such as deliverer, location, and date and time for a preregistered sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.107\" target=\"_blank\">21 CFR Part 58.107 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.8.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual D-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.13<\/b> The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.107\" target=\"_blank\">21 CFR Part 58.107 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.14<\/b> The system shall provide a user-friendly means for tracking and acknowledging the physical reception of submitted sample or specimen material in the laboratory, including date and time of reception.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.15<\/b> The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1.3\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.16<\/b> The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.2 and 2.2.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.17<\/b> The system should provide a means to document sample preparation activities for a given sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D-9\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Appendix A<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.3\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.8\u20139<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.18<\/b> The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.16\" target=\"_blank\">7 CFR Part 331.16<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.16\" target=\"_blank\">9 CFR Part 121.16<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.16\" target=\"_blank\">42 CFR Part 73.16<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.19<\/b> In the case of regulated samples (e.g., select agent or toxin, cannabis, etc.), the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.20<\/b> The system shall be able to link various records together based on a record's metadata, including sample or specimen identifier, patient number, or family identifier.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"2._Sample_management\">2. Sample management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.1<\/b> The system shall record and maintain the chain of custody for the laboratory's standards and reagents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.2<\/b> The system shall record the current and historical storage location for the laboratory's standards and reagents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.3<\/b> The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.4<\/b> The system shall require the recording of a standard and reagent's first opening date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.5<\/b> The system shall allow only active standards and reagents to be shown as available for use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.6<\/b> The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.7<\/b> The system shall allow logically associated samples or specimens to be grouped together based on associated metadata such as type, test method, assigned user, and status.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.8<\/b> The system should allow for the accurate identification of a physical sample or specimen in the system via barcode or RFID technology.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.9<\/b> The system should provide a means to manually or automatically track sample or specimen inventory amounts and status.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.10<\/b> The system shall be able to link test methods and specifications to standards and reagents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1153 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.65\" target=\"_blank\">21 CFR Part 606.65 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.151\" target=\"_blank\">21 CFR Part 606.151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10\u201312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 12.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.22\u201325<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.11<\/b> The system shall allow samples, specimens, and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, remediated testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"3._Core_laboratory_testing_and_experiments\">3. Core laboratory testing and experiments<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>3.1<\/b> The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>3.2<\/b> The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.3<\/b> The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.4<\/b> The system shall be able to check physical, control, and specification limits for an instrument sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.5<\/b> The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.6<\/b> The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.7<\/b> The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.8<\/b> The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.9<\/b> The system shall support, at a minimum, the floating point\/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.10<\/b> The system shall allow users to enter operators such as <, >, +, and - with numeric test results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.11<\/b> The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-13<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.12<\/b> The system should effectively alert users upon entry of out-of-specification test results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1153 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (c\u2013f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.325<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.161<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.202<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.160\" target=\"_blank\">21 CFR Part 606.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G16.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.10<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.1.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.1\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section II.4.i<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>3.13<\/b> The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 1.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.14<\/b> The system shall allow users to link samples, specimens, and tests to a specific accreditation approval status (e.g., World Anti-Doping Agency accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"4._Results_review_and_verification\">4. Results review and verification<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.1<\/b> The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 1.2<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.2<\/b> The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.3<\/b> The system shall accurately maintain a full audit trail for modified results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-28\u201329<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G15.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.2\u20133 and 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.4<\/b> The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.5<\/b> The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.6<\/b> The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 4.0<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>4.7<\/b> The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span id=\"rdp-ebb-5._Sample,_experiment,_and_study_approval_and_verification\"><\/span><span class=\"mw-headline\" id=\"5._Sample.2C_experiment.2C_and_study_approval_and_verification\">5. Sample, experiment, and study approval and verification<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.9\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.12.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>5.1<\/b> The system shall accurately record details of a sample or specimen's final disposition.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>5.2<\/b> The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>5.3<\/b> The system should provide appropriate functions for specific sample statuses like \"approved\" and \"rejected,\" including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"6._Reporting\">6. Reporting<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.1<\/b> The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.12\u201315<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.2<\/b> The system shall be able to export data in a computer-readable (importable into a relational database) format\u2014such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file\u2014as well as PDF format, for reporting purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (g) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.3<\/b> The system shall alert stakeholders in advance to cases when the analyzed sample may be out-of-specification or may not meet expected turnaround time requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.4<\/b> The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., \"less than X mg\/L\") when doing so would provide relevant information to the report recipient.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.25\" target=\"_blank\">7 CFR Part 91.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (c\u2013e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.10.2\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-12 and -32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.43<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.5<\/b> The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.26\" target=\"_blank\">7 CFR Part 91.26\u201327<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.6<\/b> The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.7<\/b> The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, patient results, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.5\" target=\"_blank\">7 CFR Part 331.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.5\" target=\"_blank\">9 CFR Part 121.5\u20136<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.185\" target=\"_blank\">21 CFR Part 58.185<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.64\" target=\"_blank\">21 CFR Part 312.64<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.150\" target=\"_blank\">21 CFR Part 812.150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.31\" target=\"_blank\">40 CFR Part 141.31<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.721\" target=\"_blank\">40 CFR Part 141.721<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-370\/subpart-C\" target=\"_blank\">40 CFR Part 370 Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-372\/subpart-B\" target=\"_blank\">40 CFR Part 372 Subpart B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\" target=\"_blank\">40 CFR Part 704<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-717\/subpart-A\" target=\"_blank\">40 CFR Part 717 Subpart A<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/720.40\" target=\"_blank\">40 CFR Part 720.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.5\" target=\"_blank\">42 CFR Part 73.5\u20136<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C13.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories E8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G17.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.12\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 4, 2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 4, 1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-6 and IR-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.8<\/b> The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, analytical worksheets, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.28\" target=\"_blank\">7 CFR Part 91.28<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.185\" target=\"_blank\">21 CFR Part 58 Sec. 58.185 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.10.9\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.9<\/b> The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20221202173540\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.057 seconds\nReal time usage: 0.060 seconds\nPreprocessor visited node count: 482\/1000000\nPost\u2010expand include size: 76839\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 11.378 1 -total\n 17.77% 2.022 1 Template:LIMSpec\/Sample_and_experiment_registration\n 15.99% 1.820 1 Template:LIMSpec\/Reporting\n 15.94% 1.813 1 Template:LIMSpec\/Results_review_and_verification\n 15.92% 1.811 1 Template:LIMSpec\/Sample_management\n 15.51% 1.765 1 Template:LIMSpec\/Core_laboratory_testing_and_experiments\n 14.69% 1.671 1 Template:LIMSpec\/Sample,_experiment,_and_study_approval_and_verification\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11179-0!canonical and timestamp 20221202173540 and revision id 36389. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#1._Sample_and_experiment_registration\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#1._Sample_and_experiment_registration<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","61aff0fab36cdf9b9d726a3caf608cc1_images":[],"61aff0fab36cdf9b9d726a3caf608cc1_timestamp":1670002540,"6a58610d5ca6de721882be7114c8ca86_type":"article","6a58610d5ca6de721882be7114c8ca86_title":"Introduction and methodology","6a58610d5ca6de721882be7114c8ca86_url":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Introduction_and_methodology","6a58610d5ca6de721882be7114c8ca86_plaintext":"\n\nLII:LIMSpec\/Introduction and methodologyFrom LIMSWikiJump to navigationJump to searchContents \n\n1 Introduction and methodology \n\n1.1 Introduction \n1.2 Methodology \n\n\n2 References \n\n\n\nIntroduction and methodology \nIntroduction \nMerriam-Webster defines a \"specification\" as \"a detailed precise presentation of something or of a plan or proposal for something.\"[1] In other words, an existing or theoretical product, concept, or idea is presented in detail for a particular audience. In a broad sense, detailing the specifics about a project, concept, or idea to others is just common sense. This applies just as well to the world of software development, where a software requirements specification is essential for preventing the second most commonly cited reason for project failure: poor requirements management.[2] \nIn fact, the ISO\/IEC\/IEEE 29148:2018 standard (a conglomeration of what was formerly IEEE 830 and other standards) is in place to help specify \"the required processes implemented in the engineering activities that result in requirements for systems and software products\" and provides guidelines for how to apply those requirements.[3] The standard describes the characteristics that make up quality software requirement development, including aspects such as[4]:\n\ncorrectly describing system behavior;\neffectively removing ambiguity from the language used;\ncompletely covering the system behavior and features;\naccurately prioritizing and ranking the requirements; and\nunequivocally ensuring the requirements are testable, modifiable, and traceable.\nA requirement typically comes in the form of a statement that begins with \"the system\/user\/vendor shall\/should ...\" and focuses on a provided service, reaction to input, or expected behavior in a given situation. The statement may be abstract (high-level) or specific and detailed to a precise function. The statement may also be of a functional nature, describing functionality or services in detail, or of a non-functional nature, describing the constraints of a given functionality or service and how it's rendered. An example of a functional software requirement could be \"the user shall be able to query either all of the initial set of databases or select a subset from it.\" This statement describes specific functionality the system should have. On the other hand, a non-functional requirement, for example, may state \"the system's query tool shall conform to the ABC 123-2014 standard.\" The statement describes a constraint placed upon the system's query functionality. Once compiled, a set of requirements can serve not only to strengthen the software requirements specification, but the requirements set can also be used for bidding on a contract or serve as the basis for a specific contract that is being finalized.[5]\nOver the years, a wide variety of companies, consultants, and researchers have compiled public and private software requirements specifications for laboratory informatics systems. These compiled lists of requirements for how a given laboratory informatics solution should be developed, delivered, and maintained have changed as technology and user demand have evolved. Often times, these requirements documents turn into a mix of \"wishlist\" requirements from potential and active clients, as well as regulation-mandated requirements. The wishlist items aren't necessarily ignored by developers, but they do in fact have to be prioritized as \"nice to have\" or \"essential to system operation,\" or something in between.[6][7][8] While this reasonable mix of requirements has served informatics software developers well[9], sometimes a fresh approach is required.\nWhat follows is an attempt to look less at the wishlists of laboratories and more directly at what requirements current regulatory schemes, industry standards, and organizational guidelines place on the ever-evolving array of laboratory informatics systems being developed today. What does the United States' 21 CFR Part 11 have to say about how your laboratory information management system (LIMS), laboratory information system (LIS), electronic laboratory notebook (ELN), and other systems operate? What does the European Union's Annex 11 dictate in those same regards? The following five chapters list those requirements, supported by one or more regulations, standards, and guidelines. The final chapter discusses how to best put this requirements specification to use.\n\nMethodology \nAt its core, this LIMSpec\u2014which has seen several iterations over the years\u2014is rooted in ASTM E1578-18 Standard Guide for Laboratory Informatics. The latest version was released in 2018, which includes an updated Laboratory Informatics Functional Requirements checklist in the appendix. That list of requirements \"covers functionality common to the various laboratory informatics systems discussed throughout [the] guide as well as requirements recommended as part of [the] guide.\" It goes on to state that the checklist \"is an example of typical requirements that can be used to guide the purchase, upgrade, or development of a laboratory informatics system,\" though it is certainly \"not meant to be exhaustive.\"\nThis LIMSpec borrows from that requirements checklist and then adds more to it from a wide variety of sources. An attempt has been made to find the most relevant regulations, standards, and guidance that shape how a compliant laboratory informatics system is developed and maintained. However, this should definitely be considered a work in progress, with more to be added with additional public and private comment on missing sources. \nThat said, this fourth revision (December 2022) taps into more than 130 resources, including the following:\n\n\n\n\n\n\n\nTable 1. Regulations, standards, guidance, and other documents guiding LIMSpec development. * indicates added, updated, or revised for December 2022 update.\n\n\nRegulation, Specification, or Guidance\n\nFamiliar Name and\/or Responsible Entity\n\n\n5 CFR Part 930.301\n\nOffice of Personnel Management > Civil Service Regulations > Programs for Specific Positions and Examinations (Miscellaneous) > Information Security Responsibilities for Employees who Manage or Use Federal Information Systems > Information systems security awareness training program\n\n\n7 CFR Part 91\n\nAgricultural Marketing Service (Standards, Inspections, Marketing Practices), Department of Agriculture > Commodity Laboratory Testing Programs > Services and General Information\n\n\n7 CFR Part 331\n\nAnimal and Plant Health Inspection Service, Department of Agriculture > Possession, Use, and Transfer of Select Agents and Toxins\n\n\n9 CFR Part 2\n\nAnimal and Plant Health Inspection Service, Department of Agriculture > Animal Welfare > Regulations\n\n\n9 CFR Part 121\n\nAnimal and Plant Health Inspection Service, Department of Agriculture > Viruses, Serums, Toxins, and Analogous Products; Organisms and Vectors > Possession, Use, and Transfer of Select Agents and Toxins\n\n\n10 CFR Part 20\n\nNuclear Regulatory Commission > Standards for Protection Against Radiation\n\n\n10 CFR Part 30\n\nNuclear Regulatory Commission > Rules of General Applicability to Domestic Licensing of Byproduct Material\n\n\n21 CFR Part 1*\n\nFood and Drug Administration, Department of Health and Human Services > General > General Enforcement Regulations\n\n\n21 CFR Part 7\n\nFood and Drug Administration, Department of Health and Human Services > General > Enforcement Policy\n\n\n21 CFR Part 11\n\nFood and Drug Administration, Department of Health and Human Services > General > Electronic Records; Electronic Signatures\n\n\n21 CFR Part 58\n\nFood and Drug Administration, Department of Health and Human Services > General > Good Laboratory Practice for Nonclinical Laboratory Studies\n\n\n21 CFR Part 106*\n\nFood and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications\n\n\n21 CFR Part 110*\n\nFood and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food\n\n\n21 CFR Part 111*\n\nFood and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements\n\n\n21 CFR Part 112*\n\nFood and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption\n\n\n21 CFR Part 114*\n\nFood and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Acidified Foods\n\n\n21 CFR Part 117*\n\nFood and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food\n\n\n21 CFR Part 120*\n\nFood and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Hazard Analysis and Critical Control Point (HACCP) Systems\n\n\n21 CFR Part 123*\n\nFood and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Fish and Fishery Products\n\n\n21 CFR Part 129*\n\nFood and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Processing and Bottling of Bottled Drinking Water\n\n\n21 CFR Part 211\n\nFood and Drug Administration, Department of Health and Human Services > Drugs: General > Current Good Manufacturing Practice for Finished Pharmaceuticals\n\n\n21 CFR Part 212\n\nFood and Drug Administration, Department of Health and Human Services > Drugs: General > Current Good Manufacturing Practice for Positron Emission Tomography Drugs\n\n\n21 CFR Part 225\n\nFood and Drug Administration, Department of Health and Human Services > Drugs: General > Current Good Manufacturing Practice for Medicated Feeds\n\n\n21 CFR Part 226\n\nFood and Drug Administration, Department of Health and Human Services > Drugs: General > Current Good Manufacturing Practice for Type A Medicated Articles\n\n\n21 CFR Part 312\n\nFood and Drug Administration, Department of Health and Human Services > Drugs for Human Use > Investigational New Drug Application\n\n\n21 CFR Part 507*\n\nFood and Drug Administration, Department of Health and Human Services > Animal Drugs, Feeds, and Related Products > Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Food for Animals\n\n\n21 CFR Part 606\n\nFood and Drug Administration, Department of Health and Human Services > Biologics > Current Good Manufacturing Practice for Blood and Blood Components\n\n\n21 CFR Part 810\n\nFood and Drug Administration, Department of Health and Human Services > Medical Devices > Medical Device Recall Authority\n\n\n21 CFR Part 812\n\nFood and Drug Administration, Department of Health and Human Services > Medical Devices > Investigational Device Exemptions\n\n\n21 CFR Part 820\n\nFood and Drug Administration, Department of Health and Human Services > Medical Devices > Quality System Regulation\n\n\n29 CFR Part 1910.120\n\nOccupational Safety and Health Standards > Hazardous Materials > Hazardous waste operations and emergency response\n\n\n29 CFR Part 1910.134\n\nOccupational Safety and Health Standards > Personal Protective Equipment > Respiratory protection\n\n\n29 CFR Part 1910.1030\n\nOccupational Safety and Health Standards > Toxic and Hazardous Substances > Bloodborne pathogens\n\n\n29 CFR Part 1910.1096\n\nOccupational Safety and Health Standards > Toxic and Hazardous Substances > Ionizing radiation\n\n\n29 CFR Part 1910.1200\n\nOccupational Safety and Health Standards > Toxic and Hazardous Substances > Hazard communication\n\n\n29 CFR Part 1910.1450\n\nOccupational Safety and Health Standards > Toxic and Hazardous Substances > Occupational exposure to hazardous chemicals in laboratories\n\n\n40 CFR Part 3\n\nEnvironmental Protection Agency > General > Cross-media Electronic Reporting\n\n\n40 CFR Part 60\n\nEnvironmental Protection Agency > Air Programs > Standards of Performance for New Stationary Sources\n\n\n40 CFR Part 62\n\nEnvironmental Protection Agency > Air Programs > Approval and Promulgation of State Plans for Designated Facilities and Pollutants\n\n\n40 CFR Part 63\n\nEnvironmental Protection Agency > Air Programs > National Emission Standards for Hazardous Air Pollutants for Source Categories\n\n\n40 CFR Part 141\n\nEnvironmental Protection Agency > Water Programs > National Primary Drinking Water Regulations\n\n\n40 CFR Part 262\n\nEnvironmental Protection Agency > Solid Wastes > Standards Applicable to Generators of Hazardous Waste\n\n\n40 CFR Part 370\n\nEnvironmental Protection Agency > Superfund, Emergency Planning, and Community Right-to-know Programs > Hazardous Chemical Reporting: Community Right-to-know\n\n\n40 CFR Part 372\n\nEnvironmental Protection Agency > Superfund, Emergency Planning, and Community Right-to-know Programs > Toxic Chemical Release Reporting: Community Right-to-know\n\n\n40 CFR Part 704\n\nEnvironmental Protection Agency > Toxic Substances Control Act > Reporting and Recordkeeping Requirements\n\n\n40 CFR Part 717\n\nEnvironmental Protection Agency > Toxic Substances Control Act > Records and Reports of Allegations that Chemical Substances Cause Significant Adverse Reactions to Health or the Environment\n\n\n40 CFR Part 720\n\nEnvironmental Protection Agency > Toxic Substances Control Act > Premanufacture Notification\n\n\n42 CFR Part 73\n\nPublic Health Service, Department of Health and Human Services > Quarantine, Inspection, Licensing > Select Agents and Toxins\n\n\n42 CFR Part 93\n\nPublic Health Service, Department of Health and Human Services > Health Assessments and Health Effects Studies of Hazardous Substances Releases and Facilities > Public Health Service Policies on Research Misconduct\n\n\n42 CFR Part 493\n\nCenters for Medicare & Medicaid Services, Department of Health and Human Services > Standards and Certification > Laboratory Requirements\n\n\n45 CFR Part 160\n\nDepartment of Health and Human Services > Administrative Data Standards and Related Requirements > General Administrative Requirements\n\n\n45 CFR Part 162\n\nDepartment of Health and Human Services > Administrative Data Standards and Related Requirements > Administrative Requirements\n\n\n45 CFR Part 164\n\nDepartment of Health and Human Services > Administrative Data Standards and Related Requirements > Security and Privacy\n\n\n45 CFR Part 170\n\nDepartment of Health and Human Services > Health Information Technology > Health Information Technology Standards, Implementation Specifications, and Certification Criteria and Certification Programs for Health Information Technology\n\n\n61 FR 38806*\n\nFood Safety and Inspection Service, Department of Agriculture > Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems\n\n\nA2LA C211, Specific Checklist, Combined ISO\/IEC 17025 and Veterinary Laboratory Accreditation Program\n\nAmerican Association for Laboratory Accreditation\n\n\nA2LA C223, Specific Checklist, Forensic Examination Accreditation Program-Testing\n\nAmerican Association for Laboratory Accreditation\n\n\nAAFCO QA\/QC Guidelines for Feed Laboratories\n\nAssociation of American Feed Control Officials\n\n\nAAVLD Requirements for an AVMDL\n\nAmerican Association of Veterinary Laboratory Diagnosticians\n\n\nABFT Accreditation Manual\n\nAmerican Board of Forensic Toxicology\n\n\nACMG Technical Standards for Clinical Genetics Laboratories\n\nAmerican College of Medical Genetics and Genomics\n\n\nAIHA-LAP Policies 2022\n\nAmerican Industrial Hygiene Association Laboratory Accreditation Programs\n\n\nAPHL 2019 LIS Project Management Guidebook\n\nAssociation of Public Health Laboratories\n\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories\n\nAmerican Society of Crime Laboratory Directors\/Laboratory Accreditation Board; note that ASCLD\/LAB merged with ANAB (ANSI National Accreditation Board) in 2016, and their requirements for Forensic Service Provider Accreditation are not made public. As such, this serves as a proxy for ANAB.\n\n\nASTM E1188-11\n\nASTM E1188-11(2017) Standard Practice for Collection and Preservation of Information and Physical Items by a Technical Investigator\n\n\nASTM E1459-13\n\nASTM E1459-13(2018) Standard Guide for Physical Evidence Labeling and Related Documentation\n\n\nASTM E1492-11\n\nASTM E1492-11(2017) Standard Practice for Receiving, Documenting, Storing, and Retrieving Evidence in a Forensic Science Laboratory\n\n\nASTM E1578-18\n\nASTM E1578-18 Standard Guide for Laboratory Informatics\n\n\nBRC GSFS, Issue 8*\n\nBRC Global Standards' Global Standard for Food Safety, Issue 8\n\n\nCAP Laboratory Accreditation Manual\n\nCollege of American Pathologists\n\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL)\n\nU.S. Centers for Disease Control and Prevention\n\n\nCDC PHIN Messaging System\n\nU.S. Centers for Disease Control and Prevention\n\n\nCJIS Security Policy\n\nFederal Bureau of Investigation, Criminal Justice Information Services\n\n\nCLSI AUTO15\n\nClinical and Laboratory Standards Institute\n\n\nCLSI AUTO16\n\nClinical and Laboratory Standards Institute\n\n\nCLSI QMS22\n\nClinical and Laboratory Standards Institute\n\n\nCodex Alimentarius CXC 1-1969*\n\nFood and Agriculture Organization of the United Nations' Codex Alimentarius CXC 1-1969 General Principles of Good Hygiene\n\n\nCodex Alimentarius CXS 193-1995*\n\nFood and Agriculture Organization of the United Nations' Codex Alimentarius CXS 193-1995 General Standard for Contaminants and Toxins in Food and Feed\n\n\nCodex Alimentarius CXS 234-1999*\n\nFood and Agriculture Organization of the United Nations' Codex Alimentarius CXS 234-1999 Recommended Methods of Analysis and Sampling\n\n\nDoD General Data Validation Guidelines\n\nU.S. Department of Defense\n\n\nEMA Guidance on good manufacturing practice and good distribution practice\n\nE.U. European Medicines Agency\n\n\nEPA 815-R-05-004 + supplements\n\nU.S. Environmental Protection Agency\n\n\nEPA ERLN Laboratory Requirements v1.6\n\nU.S. Environmental Protection Agency, Environmental Response Laboratory Network\n\n\nEPA Metadata Technical Specification\n\nU.S. Environmental Protection Agency\n\n\nEPA QA\/G-5\n\nU.S. Environmental Protection Agency Guidance for Quality Assurance Project Plans\n\n\nEPA SEDD Specification and Data Element Dictionary v5.2\n\nU.S. Environmental Protection Agency Staged Electronic Data Deliverable\n\n\nE.U. Annex 11\n\nEuropean Union, European Commission\n\n\nE.U. Commission Directive 2003\/94\/EC\n\nEuropean Union, European Commission\n\n\nE.U. Commission Reg. No. 852\/2004*\n\nEuropean Union, European Commission\n\n\nE.U. Commission Reg. No. 2073\/2005*\n\nEuropean Union, European Commission\n\n\nFDA Office of Regulatory Affairs Data Exchange (ORA DX) Program\n\nU.S. Food and Drug Administration\n\n\nFDA Hazard Analysis Critical Control Point (HACCP)\n\nU.S. Food and Drug Administration\n\n\nGFSI Benchmarking Rqmts., v2020.1*\n\nGlobal Food Safety Initiative Benchmarking Requirements Version 2020.1\n\n\nICAR 15 Data Exchange\n\nInternational Committee for Animal Recording\n\n\nICH GCP\n\nInternational Council for Harmonisation Good Clinical Practice\n\n\nIFS Food 7*\n\nInternational Featured Standards' Food 7 Standard\n\n\nIFS PACsecure 2*\n\nInternational Featured Standards' PACsecure 2 Standard\n\n\nISO 15189:2012\n\nISO 15189:2012 Medical laboratories \u2014 Requirements for quality and competence\n\n\nISO\/IEC 17025:2017\n\nISO\/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories\n\n\nISO\/TS 22002-1:2009*\n\nISO\/TS 22002-1:2009 Prerequisite programmes on food safety \u2014 Part 1: Food manufacturing\n\n\nISO\/TS 22002-4:2013*\n\nISO\/TS 22002-4:2013 Prerequisite programmes on food safety \u2014 Part 4: Food packaging manufacturing\n\n\nISO\/TS 22002-6:2016*\n\nISO\/TS 22002-6:2016 Prerequisite programmes on food safety \u2014 Part 6: Feed and animal food production\n\n\nNAHLN HL7 Messaging Quick User Guide\n\nNational Animal Health Laboratory Network\n\n\nNAHLN Information Technology System\n\nNational Animal Health Laboratory Network\n\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\nNew York State Department of Health Clinical Laboratory Evaluation Program\n\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\n\nNew York State Department of Health Environmental Laboratory Approval Program\n\n\nNIST 800-53, Rev. 5\n\nNational Institute of Standards and Technology\n\n\nOECD GLP Principles\n\nOrganisation for Economic Co-operation and Development Good Laboratory Practice\n\n\nONC United States Core Data for Interoperability (USCDI)\n\nOffice of the National Coordinator for Health Information Technology\n\n\nOSHA 1910.1020\n\nOccupational Safety and Health Administration 1910.1020 - Access to employee exposure and medical records\n\n\nOSHA 1910.1200\n\nOccupational Safety and Health Administration 1910.1200 - Hazard Communication\n\n\nOSHA 1910.1450\n\nOccupational Safety and Health Administration 1910.1450 - Occupational exposure to hazardous chemicals in laboratories\n\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\n\nPartnership for Food Protection\n\n\nSafe Food for Canadians Regulations SOR\/2018-108*\n\nGovernment of Canada, Governor General of Canada\n\n\nSQF FSC 9, Food Manufacturing*\n\nFMI, The Food Industry Association, SQF Institute's Food Safety Code: Manufacture of Food Packaging, Ninth Edition\n\n\nSQF FSC 9, Pet Food Manufacturing*\n\nFMI, The Food Industry Association, SQF Institute's Food Safety Code: Pet Food Manufacturing, Ninth Edition\n\n\nSQF FSC 9, Manufacture of Food Packaging*\n\nFMI, The Food Industry Association, SQF Institute's Food Safety Code: Manufacture of Food Packaging, Ninth Edition\n\n\nTNI EL-V1-2016-Rev.2.1\n\nThe NELAC Institute Management and Technical Requirements for Laboratories Performing Environmental Analysis, Volume 1\n\n\nUSDA Administrative Procedures for the Pesticide Data Program (PDP)\n\nU.S. Department of Agriculture\n\n\nUSDA Data and Instrumentation for Pesticide Data Program\n\nU.S. Department of Agriculture\n\n\nUSDA Hemp Production Program Laboratory Testing Guidelines\n\nU.S. Department of Agriculture\n\n\nUSDA Laboratory Approval Service (LAS) Laboratory Approval Program (LAP) Policies and Procedures\n\nU.S. Department of Agriculture\n\n\nUSDA Sample Processing and Analysis Procedures for Pesticide Data Program\n\nU.S. Department of Agriculture\n\n\nUSDA Sampling Procedures for Pesticide Data Program\n\nU.S. Department of Agriculture\n\n\nVeNom Coding Group terminology\n\nVeterinary Nomenclature\n\n\nVTSL terminology\n\nVeterinary Terminology Services Laboratory at Virginia-Maryland College of Veterinary Medicine\n\n\nVICH GL53\n\nVeterinary International Conference on Harmonization GL53 Electronic Exchange of Documents: Electronic File Format\n\n\nWADA International Standard for Laboratories (ISL)\n\nWorld Anti-Doping Agency\n\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI)\n\nWorld Anti-Doping Agency\n\n\nWHO Technical Report Series, #961, Annex 13\n\nWorld Health Organization TRS, #961, Annex 13 Guidelines for preparing a laboratory information file\n\n\nWHO Technical Report Series, #986, Annex 2\n\nWorld Health Organization TRS, #986, Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles\n\n\nWHO Technical Report Series, #996, Annex 5\n\nWorld Health Organization TRS, #996, Annex 5 Guidance on good data and record management practices\n\n\n\nEach requirement statement has at least one linked regulation, standard, or guidance item. In some cases, the standards covered are proprietary. In those cases, the standard was either purchased for review or heavily researched using supporting documentation, and the link goes to the acquisition page for the standard. In other cases, some sources have been intentionally omitted. For example, the AOAC International Official Methods of Analysis and Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals are both proprietary and more or less prohibitively expensive. In other cases, such as with the U.S. Food Emergency Response Network and Laboratory Response Network, they simply don't make their standardized procedures open to the public and thus can't be included.\n\nReferences \n\n\n\u2191 \"specification\". Merriam-Webster. Merriam-Webster, Inc. https:\/\/www.merriam-webster.com\/dictionary\/specification . Retrieved 27 April 2022 .   \n \n\n\u2191 Bieg, D.P. (August 2014). \"Introduction\" (PDF). Requirements Management: A Core Competency for Project and Program Success. Project Management Institute. p. 3. https:\/\/www.pmi.org\/-\/media\/pmi\/documents\/public\/pdf\/learning\/thought-leadership\/pulse\/requirements-management.pdf . Retrieved 27 April 2022 .   \n \n\n\u2191 \"ISO\/IEC\/IEEE 29148:2018\". International Organization for Standardization. November 2018. https:\/\/www.iso.org\/standard\/72089.html . Retrieved 27 April 2022 .   \n \n\n\u2191 Seibert, P. (28 July 2011). \"How do you write software requirements? What are software requirements? What is a software requirement?\". HubTechInsider. https:\/\/hubtechinsider.wordpress.com\/2011\/07\/28\/how-do-you-write-software-requirements-what-are-software-requirements-what-is-a-software-requirement\/ . Retrieved 27 April 2022 .   \n \n\n\u2191 Memon, A. (Spring 2010). \"Software Requirements: Descriptions and specifications of a system\" (PDF). University of Maryland. https:\/\/www.cs.umd.edu\/~atif\/Teaching\/Spring2010\/Slides\/3.pdf . Retrieved 27 April 2022 .   \n \n\n\u2191 Aasem, M.; Ramzan, M.; Jaffar, A. (2010). \"Analysis and optimization of software requirements prioritization techniques\". Proceedings from the 2010 International Conference on Information and Emerging Technologies: 1\u20136. doi:10.1109\/ICIET.2010.5625687.   \n \n\n\u2191 Hirsch, J. (22 November 2013). \"10 Steps To Successful Requirements Gathering\". Phase2 Technology, LLC. https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering . Retrieved 27 April 2022 .   \n \n\n\u2191 Burris, E. (2007). \"Requirements Specification\". CS451R, University of Missouri\u2013Kansas City. University of Missouri\u2013Kansas City. Archived from the original on 24 July 2019. https:\/\/web.archive.org\/web\/20190724173601\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/ . Retrieved 27 April 2022 .   \n \n\n\u2191 Hofmann, H.F.; Lehner, F. (2001). \"Requirements engineering as a success factor in software projects\". IEEE Software 18 (4): 58\u201366. doi:10.1109\/MS.2001.936219.   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Introduction_and_methodology\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Introduction_and_methodology<\/a>\nNavigation menuPage actionsLIIDiscussionView sourceHistoryPage actionsLIIDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 22 January 2022, at 19:33.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2,518 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","6a58610d5ca6de721882be7114c8ca86_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-202 ns-subject page-LII_LIMSpec_Introduction_and_methodology rootpage-LII_LIMSpec_Introduction_and_methodology skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:LIMSpec\/Introduction and methodology<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\">\n\n<h2><span class=\"mw-headline\" id=\"Introduction_and_methodology\">Introduction and methodology<\/span><\/h2>\n<h3><span class=\"mw-headline\" id=\"Introduction\">Introduction<\/span><\/h3>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Systems_Requirement_Analysis.jpg\" class=\"image wiki-link\" data-key=\"cdbc7c51db09035738b016eb74416252\"><img alt=\"Systems Requirement Analysis.jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/9\/9b\/Systems_Requirement_Analysis.jpg\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div><p>Merriam-Webster defines a \"specification\" as \"a detailed precise presentation of something or of a plan or proposal for something.\"<sup id=\"rdp-ebb-cite_ref-MWSpec_1-0\" class=\"reference\"><a href=\"#cite_note-MWSpec-1\">[1]<\/a><\/sup> In other words, an existing or theoretical product, concept, or idea is presented in detail for a particular audience. In a broad sense, detailing the specifics about a project, concept, or idea to others is just common sense. This applies just as well to the world of software development, where a software requirements specification is essential for preventing the second most commonly cited reason for project failure: poor requirements management.<sup id=\"rdp-ebb-cite_ref-BiegRequire14_2-0\" class=\"reference\"><a href=\"#cite_note-BiegRequire14-2\">[2]<\/a><\/sup> \n<\/p><p>In fact, the ISO\/IEC\/IEEE 29148:2018 standard (a conglomeration of what was formerly IEEE 830 and other standards) is in place to help specify \"the required processes implemented in the engineering activities that result in requirements for systems and software products\" and provides guidelines for how to apply those requirements.<sup id=\"rdp-ebb-cite_ref-ISO29148_3-0\" class=\"reference\"><a href=\"#cite_note-ISO29148-3\">[3]<\/a><\/sup> The standard describes the characteristics that make up quality software requirement development, including aspects such as<sup id=\"rdp-ebb-cite_ref-SeibertHowDoYou11_4-0\" class=\"reference\"><a href=\"#cite_note-SeibertHowDoYou11-4\">[4]<\/a><\/sup>:\n<\/p>\n<ul><li>correctly describing system behavior;<\/li>\n<li>effectively removing ambiguity from the language used;<\/li>\n<li>completely covering the system behavior and features;<\/li>\n<li>accurately prioritizing and ranking the requirements; and<\/li>\n<li>unequivocally ensuring the requirements are testable, modifiable, and traceable.<\/li><\/ul>\n<p>A requirement typically comes in the form of a statement that begins with \"the system\/user\/vendor shall\/should ...\" and focuses on a provided service, reaction to input, or expected behavior in a given situation. The statement may be abstract (high-level) or specific and detailed to a precise function. The statement may also be of a functional nature, describing functionality or services in detail, or of a non-functional nature, describing the constraints of a given functionality or service and how it's rendered. An example of a functional software requirement could be \"the user shall be able to query either all of the initial set of databases or select a subset from it.\" This statement describes specific functionality the system should have. On the other hand, a non-functional requirement, for example, may state \"the system's query tool shall conform to the ABC 123-2014 standard.\" The statement describes a constraint placed upon the system's query functionality. Once compiled, a set of requirements can serve not only to strengthen the software requirements specification, but the requirements set can also be used for bidding on a contract or serve as the basis for a specific contract that is being finalized.<sup id=\"rdp-ebb-cite_ref-MemonSoftware10_5-0\" class=\"reference\"><a href=\"#cite_note-MemonSoftware10-5\">[5]<\/a><\/sup>\n<\/p><p>Over the years, a wide variety of companies, consultants, and researchers have compiled public and private software requirements specifications for <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_informatics\" title=\"Laboratory informatics\" class=\"wiki-link\" data-key=\"00edfa43edcde538a695f6d429280301\">laboratory informatics<\/a> systems. These compiled lists of requirements for how a given laboratory informatics solution should be developed, delivered, and maintained have changed as technology and user demand have evolved. Often times, these requirements documents turn into a mix of \"wishlist\" requirements from potential and active clients, as well as regulation-mandated requirements. The wishlist items aren't necessarily ignored by developers, but they do in fact have to be prioritized as \"nice to have\" or \"essential to system operation,\" or something in between.<sup id=\"rdp-ebb-cite_ref-AasemAnalysis10_6-0\" class=\"reference\"><a href=\"#cite_note-AasemAnalysis10-6\">[6]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Hirsch10Steps13_7-0\" class=\"reference\"><a href=\"#cite_note-Hirsch10Steps13-7\">[7]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BurrissSoftware07_8-0\" class=\"reference\"><a href=\"#cite_note-BurrissSoftware07-8\">[8]<\/a><\/sup> While this reasonable mix of requirements has served informatics software developers well<sup id=\"rdp-ebb-cite_ref-HofmannRequire01_9-0\" class=\"reference\"><a href=\"#cite_note-HofmannRequire01-9\">[9]<\/a><\/sup>, sometimes a fresh approach is required.\n<\/p><p>What follows is an attempt to look less at the wishlists of laboratories and more directly at what requirements current regulatory schemes, industry standards, and organizational guidelines place on the ever-evolving array of laboratory informatics systems being developed today. What does the United States' <a href=\"https:\/\/www.limswiki.org\/index.php\/21_CFR_Part_11\" title=\"21 CFR Part 11\" class=\"wiki-link\" data-key=\"0ec495c20a8f17894bd0c1388eda8e7a\">21 CFR Part 11<\/a> have to say about how your <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_management_system\" title=\"Laboratory information management system\" class=\"wiki-link\" data-key=\"8ff56a51d34c9b1806fcebdcde634d00\">laboratory information management system<\/a> (LIMS), <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_system\" title=\"Laboratory information system\" class=\"wiki-link\" data-key=\"37add65b4d1c678b382a7d4817a9cf64\">laboratory information system<\/a> (LIS), <a href=\"https:\/\/www.limswiki.org\/index.php\/Electronic_laboratory_notebook\" title=\"Electronic laboratory notebook\" class=\"wiki-link\" data-key=\"a9fbbd5e0807980106763fab31f1e72f\">electronic laboratory notebook<\/a> (ELN), and other systems operate? What does the European Union's Annex 11 dictate in those same regards? The following five chapters list those requirements, supported by one or more regulations, standards, and guidelines. The final chapter discusses how to best put this requirements specification to use.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Methodology\">Methodology<\/span><\/h3>\n<p>At its core, this LIMSpec\u2014which has seen several iterations over the years\u2014is rooted in <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> <i>Standard Guide for Laboratory Informatics<\/i>. The latest version was released in 2018, which includes an updated Laboratory Informatics Functional Requirements checklist in the appendix. That list of requirements \"covers functionality common to the various laboratory informatics systems discussed throughout [the] guide as well as requirements recommended as part of [the] guide.\" It goes on to state that the checklist \"is an example of typical requirements that can be used to guide the purchase, upgrade, or development of a laboratory informatics system,\" though it is certainly \"not meant to be exhaustive.\"\n<\/p><p>This LIMSpec borrows from that requirements checklist and then adds more to it from a wide variety of sources. An attempt has been made to find the most relevant regulations, standards, and guidance that shape how a compliant laboratory informatics system is developed and maintained. However, this should definitely be considered a work in progress, with more to be added with additional public and private comment on missing sources. \n<\/p><p>That said, this fourth revision (December 2022) taps into more than 130 resources, including the following:\n<\/p>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<td colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\"><b>Table 1.<\/b> Regulations, standards, guidance, and other documents guiding LIMSpec development. <sup>*<\/sup> indicates added, updated, or revised for December 2022 update.\n<\/td><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Familiar Name and\/or Responsible Entity\n<\/th><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Office of Personnel Management > Civil Service Regulations > Programs for Specific Positions and Examinations (Miscellaneous) > Information Security Responsibilities for Employees who Manage or Use Federal Information Systems > Information systems security awareness training program\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-91\" target=\"_blank\">7 CFR Part 91<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Agricultural Marketing Service (Standards, Inspections, Marketing Practices), Department of Agriculture > Commodity Laboratory Testing Programs > Services and General Information\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Animal and Plant Health Inspection Service, Department of Agriculture > Possession, Use, and Transfer of Select Agents and Toxins\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-2\" target=\"_blank\">9 CFR Part 2<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Animal and Plant Health Inspection Service, Department of Agriculture > Animal Welfare > Regulations\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Animal and Plant Health Inspection Service, Department of Agriculture > Viruses, Serums, Toxins, and Analogous Products; Organisms and Vectors > Possession, Use, and Transfer of Select Agents and Toxins\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/part-20\" target=\"_blank\">10 CFR Part 20<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Nuclear Regulatory Commission > Standards for Protection Against Radiation\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/part-30\" target=\"_blank\">10 CFR Part 30<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Nuclear Regulatory Commission > Rules of General Applicability to Domestic Licensing of Byproduct Material\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > General > General Enforcement Regulations\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > General > Enforcement Policy\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-11\" target=\"_blank\">21 CFR Part 11<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > General > Electronic Records; Electronic Signatures\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > General > Good Laboratory Practice for Nonclinical Laboratory Studies\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Acidified Foods\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Hazard Analysis and Critical Control Point (HACCP) Systems\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Fish and Fishery Products\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Processing and Bottling of Bottled Drinking Water\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Drugs: General > Current Good Manufacturing Practice for Finished Pharmaceuticals\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Drugs: General > Current Good Manufacturing Practice for Positron Emission Tomography Drugs\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Drugs: General > Current Good Manufacturing Practice for Medicated Feeds\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Drugs: General > Current Good Manufacturing Practice for Type A Medicated Articles\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Drugs for Human Use > Investigational New Drug Application\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Animal Drugs, Feeds, and Related Products > Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Food for Animals\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Biologics > Current Good Manufacturing Practice for Blood and Blood Components\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Medical Devices > Medical Device Recall Authority\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Medical Devices > Investigational Device Exemptions\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Medical Devices > Quality System Regulation\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Occupational Safety and Health Standards > Hazardous Materials > Hazardous waste operations and emergency response\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Occupational Safety and Health Standards > Personal Protective Equipment > Respiratory protection\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Occupational Safety and Health Standards > Toxic and Hazardous Substances > Bloodborne pathogens\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Occupational Safety and Health Standards > Toxic and Hazardous Substances > Ionizing radiation\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Occupational Safety and Health Standards > Toxic and Hazardous Substances > Hazard communication\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Occupational Safety and Health Standards > Toxic and Hazardous Substances > Occupational exposure to hazardous chemicals in laboratories\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-3\" target=\"_blank\">40 CFR Part 3<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Environmental Protection Agency > General > Cross-media Electronic Reporting\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-60\" target=\"_blank\">40 CFR Part 60<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Environmental Protection Agency > Air Programs > Standards of Performance for New Stationary Sources\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-62\" target=\"_blank\">40 CFR Part 62<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Environmental Protection Agency > Air Programs > Approval and Promulgation of State Plans for Designated Facilities and Pollutants\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-63\" target=\"_blank\">40 CFR Part 63<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Environmental Protection Agency > Air Programs > National Emission Standards for Hazardous Air Pollutants for Source Categories\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-141\" target=\"_blank\">40 CFR Part 141<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Environmental Protection Agency > Water Programs > National Primary Drinking Water Regulations\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-262\" target=\"_blank\">40 CFR Part 262<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Environmental Protection Agency > Solid Wastes > Standards Applicable to Generators of Hazardous Waste\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-370\" target=\"_blank\">40 CFR Part 370<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Environmental Protection Agency > Superfund, Emergency Planning, and Community Right-to-know Programs > Hazardous Chemical Reporting: Community Right-to-know\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-372\" target=\"_blank\">40 CFR Part 372<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Environmental Protection Agency > Superfund, Emergency Planning, and Community Right-to-know Programs > Toxic Chemical Release Reporting: Community Right-to-know\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\" target=\"_blank\">40 CFR Part 704<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Environmental Protection Agency > Toxic Substances Control Act > Reporting and Recordkeeping Requirements\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-717\" target=\"_blank\">40 CFR Part 717<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Environmental Protection Agency > Toxic Substances Control Act > Records and Reports of Allegations that Chemical Substances Cause Significant Adverse Reactions to Health or the Environment\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-720\" target=\"_blank\">40 CFR Part 720<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Environmental Protection Agency > Toxic Substances Control Act > Premanufacture Notification\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Public Health Service, Department of Health and Human Services > Quarantine, Inspection, Licensing > Select Agents and Toxins\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-93\" target=\"_blank\">42 CFR Part 93<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Public Health Service, Department of Health and Human Services > Health Assessments and Health Effects Studies of Hazardous Substances Releases and Facilities > Public Health Service Policies on Research Misconduct\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-493\" target=\"_blank\">42 CFR Part 493<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Centers for Medicare & Medicaid Services, Department of Health and Human Services > Standards and Certification > Laboratory Requirements\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-160\" target=\"_blank\">45 CFR Part 160<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Department of Health and Human Services > Administrative Data Standards and Related Requirements > General Administrative Requirements\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-162\" target=\"_blank\">45 CFR Part 162<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Department of Health and Human Services > Administrative Data Standards and Related Requirements > Administrative Requirements\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Department of Health and Human Services > Administrative Data Standards and Related Requirements > Security and Privacy\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-170\" target=\"_blank\">45 CFR Part 170<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Department of Health and Human Services > Health Information Technology > Health Information Technology Standards, Implementation Specifications, and Certification Criteria and Certification Programs for Health Information Technology\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food Safety and Inspection Service, Department of Agriculture > Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211, Specific Checklist, Combined ISO\/IEC 17025 and Veterinary Laboratory Accreditation Program<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">American Association for Laboratory Accreditation\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223, Specific Checklist, Forensic Examination Accreditation Program-Testing<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">American Association for Laboratory Accreditation\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Association of American Feed Control Officials\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">American Association of Veterinary Laboratory Diagnosticians\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">American Board of Forensic Toxicology\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">American College of Medical Genetics and Genomics\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2022<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">American Industrial Hygiene Association Laboratory Accreditation Programs\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Association of Public Health Laboratories\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">American Society of Crime Laboratory Directors\/Laboratory Accreditation Board; note that ASCLD\/LAB merged with ANAB (ANSI National Accreditation Board) in 2016, and their requirements for Forensic Service Provider Accreditation are not made public. As such, this serves as a proxy for ANAB.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">ASTM E1188-11(2017) <i>Standard Practice for Collection and Preservation of Information and Physical Items by a Technical Investigator<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">ASTM E1459-13(2018) <i>Standard Guide for Physical Evidence Labeling and Related Documentation<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">ASTM E1492-11(2017) <i>Standard Practice for Receiving, Documenting, Storing, and Retrieving Evidence in a Forensic Science Laboratory<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">ASTM E1578-18 <i>Standard Guide for Laboratory Informatics<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">BRC Global Standards' Global Standard for Food Safety, Issue 8\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">College of American Pathologists\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL)<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Centers for Disease Control and Prevention\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/phin\/tools\/phinms\/index.html\" target=\"_blank\">CDC PHIN Messaging System<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Centers for Disease Control and Prevention\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Federal Bureau of Investigation, Criminal Justice Information Services\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/automation-and-informatics\/documents\/auto15\/\" target=\"_blank\">CLSI AUTO15<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Clinical and Laboratory Standards Institute\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/automation-and-informatics\/documents\/auto16\/\" target=\"_blank\">CLSI AUTO16<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Clinical and Laboratory Standards Institute\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Clinical and Laboratory Standards Institute\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Agriculture Organization of the United Nations' Codex Alimentarius CXC 1-1969 <i>General Principles of Good Hygiene<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Agriculture Organization of the United Nations' Codex Alimentarius CXS 193-1995 <i>General Standard for Contaminants and Toxins in Food and Feed<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Agriculture Organization of the United Nations' Codex Alimentarius CXS 234-1999 <i>Recommended Methods of Analysis and Sampling<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/denix.osd.mil\/edqw\/documents\/documents\/gen-data-validation-rev1\/\" target=\"_blank\">DoD General Data Validation Guidelines<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Department of Defense\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on good manufacturing practice and good distribution practice<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">E.U. European Medicines Agency\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/dwlabcert\/laboratory-certification-manual-drinking-water\" target=\"_blank\">EPA 815-R-05-004 + supplements<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Environmental Protection Agency\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/emergency-response\/environmental-response-laboratory-network-erln-laboratory-requirements\" target=\"_blank\">EPA ERLN Laboratory Requirements v1.6<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Environmental Protection Agency, Environmental Response Laboratory Network\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/geospatial\/epa-metadata-technical-specification\" target=\"_blank\">EPA Metadata Technical Specification<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Environmental Protection Agency\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Environmental Protection Agency Guidance for Quality Assurance Project Plans\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi\/P100WP4J.PDF?Dockey=P100WP4J.PDF\" target=\"_blank\">EPA SEDD Specification and Data Element Dictionary v5.2<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Environmental Protection Agency Staged Electronic Data Deliverable\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">European Union, European Commission\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">European Union, European Commission\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">European Union, European Commission\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">European Union, European Commission\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/orapartners.fda.gov\/cs\/groups\/public\/documents\/document\/b2hh\/bmri\/~edisp\/rpohandbook.pdf\" target=\"_blank\">FDA Office of Regulatory Affairs Data Exchange (ORA DX) Program<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Food and Drug Administration\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (HACCP)<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Food and Drug Administration\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Global Food Safety Initiative Benchmarking Requirements Version 2020.1\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.icar.org\/Guidelines\/15-Data-Exchange.pdf\" target=\"_blank\">ICAR 15 Data Exchange<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">International Committee for Animal Recording\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">International Council for Harmonisation Good Clinical Practice\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">International Featured Standards' Food 7 Standard\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">International Featured Standards' PACsecure 2 Standard\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">ISO 15189:2012 <i>Medical laboratories \u2014 Requirements for quality and competence<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">ISO\/IEC 17025:2017 <i>General requirements for the competence of testing and calibration laboratories<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">ISO\/TS 22002-1:2009 <i>Prerequisite programmes on food safety \u2014 Part 1: Food manufacturing<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">ISO\/TS 22002-4:2013 <i>Prerequisite programmes on food safety \u2014 Part 4: Food packaging manufacturing<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">ISO\/TS 22002-6:2016 <i>Prerequisite programmes on food safety \u2014 Part 6: Feed and animal food production<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphis.usda.gov\/animal_health\/nahln\/downloads\/MessagingQuickGuide.pdf\" target=\"_blank\">NAHLN HL7 Messaging Quick User Guide<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">National Animal Health Laboratory Network\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20170509221853\/https:\/\/www.aphis.usda.gov\/aphis\/ourfocus\/animalhealth\/lab-info-services\/nahln\/ct_nahln_it\" target=\"_blank\">NAHLN Information Technology System<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">National Animal Health Laboratory Network\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">New York State Department of Health Clinical Laboratory Evaluation Program\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">New York State Department of Health Environmental Laboratory Approval Program\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">National Institute of Standards and Technology\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Organisation for Economic Co-operation and Development Good Laboratory Practice\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healthit.gov\/isa\/united-states-core-data-interoperability-uscdi\" target=\"_blank\">ONC United States Core Data for Interoperability (USCDI)<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Office of the National Coordinator for Health Information Technology\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Occupational Safety and Health Administration 1910.1020 - <i>Access to employee exposure and medical records<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1200<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Occupational Safety and Health Administration 1910.1200 - <i>Hazard Communication<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Occupational Safety and Health Administration 1910.1450 - <i>Occupational exposure to hazardous chemicals in laboratories<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Partnership for Food Protection\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Government of Canada, Governor General of Canada\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">FMI, The Food Industry Association, SQF Institute's Food Safety Code: Manufacture of Food Packaging, Ninth Edition\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">FMI, The Food Industry Association, SQF Institute's Food Safety Code: Pet Food Manufacturing, Ninth Edition\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">FMI, The Food Industry Association, SQF Institute's Food Safety Code: Manufacture of Food Packaging, Ninth Edition\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">The NELAC Institute <i>Management and Technical Requirements for Laboratories Performing Environmental Analysis<\/i>, Volume 1\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the Pesticide Data Program (PDP)<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Department of Agriculture\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for Pesticide Data Program<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Department of Agriculture\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Department of Agriculture\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA Laboratory Approval Service (LAS) Laboratory Approval Program (LAP) Policies and Procedures<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Department of Agriculture\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for Pesticide Data Program<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Department of Agriculture\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for Pesticide Data Program<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Department of Agriculture\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/venomcoding.org\/\" target=\"_blank\">VeNom Coding Group terminology<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Veterinary Nomenclature\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vtsl.vetmed.vt.edu\/\" target=\"_blank\">VTSL terminology<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Veterinary Terminology Services Laboratory at Virginia-Maryland College of Veterinary Medicine\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vichsec.org\/en\/guidelines\/general\" target=\"_blank\">VICH GL53<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Veterinary International Conference on Harmonization GL53 <i>Electronic Exchange of Documents: Electronic File Format<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL)<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">World Anti-Doping Agency\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI)<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">World Anti-Doping Agency\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">World Health Organization TRS, #961, Annex 13 <i>Guidelines for preparing a laboratory information file<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">World Health Organization TRS, #986, Annex 2 <i>WHO good manufacturing practices for pharmaceutical products: main principles<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">World Health Organization TRS, #996, Annex 5 <i>Guidance on good data and record management practices<\/i>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<p>Each requirement statement has at least one linked regulation, standard, or guidance item. In some cases, the standards covered are proprietary. In those cases, the standard was either purchased for review or heavily researched using supporting documentation, and the link goes to the acquisition page for the standard. In other cases, some sources have been intentionally omitted. For example, the AOAC International <i>Official Methods of Analysis<\/i> and <i>Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals<\/i> are both proprietary and more or less prohibitively expensive. In other cases, such as with the U.S. Food Emergency Response Network and Laboratory Response Network, they simply don't make their standardized procedures open to the public and thus can't be included.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap\"><ol class=\"references\">\n<li id=\"cite_note-MWSpec-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MWSpec_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.merriam-webster.com\/dictionary\/specification\" target=\"_blank\">\"specification\"<\/a>. <i>Merriam-Webster<\/i>. 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Retrieved 27 April 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=10+Steps+To+Successful+Requirements+Gathering&rft.atitle=&rft.aulast=Hirsch%2C+J.&rft.au=Hirsch%2C+J.&rft.date=22+November+2013&rft.pub=Phase2+Technology%2C+LLC&rft_id=https%3A%2F%2Fwww.phase2technology.com%2Fblog%2Fsuccessful-requirements-gathering&rfr_id=info:sid\/en.wikipedia.org:LII:LIMSpec\/Introduction_and_methodology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BurrissSoftware07-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BurrissSoftware07_8-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Burris, E. (2007). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20190724173601\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/\" target=\"_blank\">\"Requirements Specification\"<\/a>. <i>CS451R, University of Missouri\u2013Kansas City<\/i>. University of Missouri\u2013Kansas City. Archived from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/\" target=\"_blank\">the original<\/a> on 24 July 2019<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20190724173601\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/\" target=\"_blank\">https:\/\/web.archive.org\/web\/20190724173601\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 27 April 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Requirements+Specification&rft.atitle=CS451R%2C+University+of+Missouri%E2%80%93Kansas+City&rft.aulast=Burris%2C+E.&rft.au=Burris%2C+E.&rft.date=2007&rft.pub=University+of+Missouri%E2%80%93Kansas+City&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20190724173601%2Fhttp%3A%2F%2Fsce2.umkc.edu%2FBIT%2Fburrise%2Fpl%2Frequirements%2F&rfr_id=info:sid\/en.wikipedia.org:LII:LIMSpec\/Introduction_and_methodology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HofmannRequire01-9\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HofmannRequire01_9-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Hofmann, H.F.; Lehner, F. (2001). \"Requirements engineering as a success factor in software projects\". <i>IEEE Software<\/i> <b>18<\/b> (4): 58\u201366. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1109%2FMS.2001.936219\" target=\"_blank\">10.1109\/MS.2001.936219<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Requirements+engineering+as+a+success+factor+in+software+projects&rft.jtitle=IEEE+Software&rft.aulast=Hofmann%2C+H.F.%3B+Lehner%2C+F.&rft.au=Hofmann%2C+H.F.%3B+Lehner%2C+F.&rft.date=2001&rft.volume=18&rft.issue=4&rft.pages=58%E2%80%9366&rft_id=info:doi\/10.1109%2FMS.2001.936219&rfr_id=info:sid\/en.wikipedia.org:LII:LIMSpec\/Introduction_and_methodology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20221202173252\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.115 seconds\nReal time usage: 0.122 seconds\nPreprocessor visited node count: 6293\/1000000\nPost\u2010expand include size: 88485\/2097152 bytes\nTemplate argument size: 16969\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 13845\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 86.820 1 -total\n 92.42% 80.241 1 Template:Reflist\n 68.53% 59.500 9 Template:Citation\/core\n 55.90% 48.535 7 Template:Cite_web\n 24.59% 21.350 2 Template:Cite_journal\n 10.90% 9.464 6 Template:Date\n 8.86% 7.692 2 Template:Citation\/identifier\n 7.47% 6.485 1 Template:LIMSpec\/Introduction_and_methodology\n 4.55% 3.949 14 Template:Citation\/make_link\n 2.62% 2.276 4 Template:Hide_in_print\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11182-0!canonical and timestamp 20221202173252 and revision id 45960. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Introduction_and_methodology\">https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Introduction_and_methodology<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","6a58610d5ca6de721882be7114c8ca86_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/9\/9b\/Systems_Requirement_Analysis.jpg"],"6a58610d5ca6de721882be7114c8ca86_timestamp":1670002540,"71418df45ef46a0f40bd390be0bd5434":{"type":"chapter","title":"1. 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Reporting","id":"671d88f9d757ca0494ddc846debb4903","pageUrl":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Primary_Laboratory_Workflow#6._Reporting"}]},{"type":"chapter","name":"3. Maintaining Laboratory Workflow and Operations","id":"7a31c2a25334b3f958d7ebe6d28817be","children":[{"type":"article","name":"7. Document and records management","id":"a764b39a539286107f8212ee654db87b","pageUrl":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#7._Document_and_records_management"},{"type":"article","name":"8. Resource management","id":"fe6f7831accf9866e7094abebdb6a6a1","pageUrl":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#8._Resource_management"},{"type":"article","name":"9. 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Instrument data capture and control","id":"c6dfe1e98f618e279fa954664ddfbb66","pageUrl":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#13._Instrument_data_capture_and_control"},{"type":"article","name":"14. Standard and reagent management","id":"9f172b7fc3c58eff808f985a33cdba7e","pageUrl":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#14._Standard_and_reagent_management"},{"type":"article","name":"15. Inventory management","id":"2d51a618475d6fdd30e9db36ce3c6512","pageUrl":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#15._Inventory_management"},{"type":"article","name":"16. Investigation and quality management","id":"a831dc6b2450793264d359a92c01fa15","pageUrl":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Maintaining_Laboratory_Workflow_and_Operations#16._Investigation_and_quality_management"}]},{"type":"chapter","name":"4. Specialty Laboratory Functions","id":"c61c22f2a2ad55bbb070a7ebe3b9a462","children":[{"type":"article","name":"17. Production management","id":"4a86c66dbb770905efc543883944afb7","pageUrl":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#17._Production_management"},{"type":"article","name":"18. Statistical trending and control charts","id":"5bf95a1f218d7809238a0eb597aff931","pageUrl":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Specialty_Laboratory_Functions#18._Statistical_trending_and_control_charts"},{"type":"article","name":"19. 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Lean laboratory and continuous improvement","id":"85b819c0b9017f33292ab934d84712b4","pageUrl":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Technology_and_Performance_Improvements#29._Lean_laboratory_and_continuous_improvement"},{"type":"article","name":"30. Artificial intelligence and smart systems","id":"8ebbeb8bfec6319a409d1d0afffa6cbf","pageUrl":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Technology_and_Performance_Improvements#30._Artificial_intelligence_and_smart_systems"}]},{"type":"chapter","name":"6. Security and Integrity of Systems and Operations","id":"2c9aefc5353c990014f4af421d73c723","children":[{"type":"article","name":"31. Data integrity","id":"eedafbce6e4049ac527deb43a1e2311d","pageUrl":"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec\/Security_and_Integrity_of_Systems_and_Operations#31._Data_integrity"},{"type":"article","name":"32. 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LIMSpec 2022 R2
A Regulatory-, Standards-, and Guidance-based Laboratory Informatics Specification
Editor: Shawn Douglas
Publisher: LabLynx Press
Copyright LabLynx Inc. All rights reserved.